,,ii #aafth ,,congress #ast ,session ,s4 #ahja ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #ab1 #bjai,ms4 ,smith 7for herself1 ,ms4 ,klobuchar1 ,mr4 ,blumenthal1 ,mr4 ,udall1 ,mr4 ,brown1 ,ms4 ,warren1 ,mr4 ,sanders1 ,ms4 ,hassan1 ,mr4 ,whitehouse1 ,mr4 ,merkley1 ,mr4 ,reed1 ,ms4 ,baldwin1 ,mr4 ,booker1 ,mr4 ,durbin1 and ,mrs4 ,gillibrand7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to ensure medications are affordable4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,affordable ,medications ,act4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,title ,i--,transparency ,sec4 #aja4 ,drug manufacturer reporting4 ,sec4 #ajb4 ,determining the public and private benefit of copayment coupons and other patient assistance programs4 ,title ,,ii--,access and ,affordability ,sec4 #bja4 ,negotiating fair prices for ,medicare prescription drugs4 ,sec4 #bjb4 ,prescription drug price spikes4 ,sec4 #bjc4 ,importing affordable and safe drugs4 ,sec4 #bjd4 ,requiring drug manufacturers to provide drug rebates for drugs dispensed to low-income individuals4 ,sec4 #bje4 ,cap on prescription drug cost-sharing4 ,sec4 #bjf4 ,modification of trade negotiating objectives relating to intellectual property rights to ensure access to biological products4 ,title ,,iii--,innovation ,sec4 #cja4 ,innovation incentive fund for new and more effective treatments of bacterial infections4 ,sec4 #cjb4 ,public funding for clinical trials4 ,sec4 #cjc4 ,rewarding innovative drug development4 ,sec4 #cjd4 ,improving program integrity4 ,title ,,iv--,choice and ,competition ,sec4 #dja4 ,unlawful compensation for delay4 ,sec4 #djb4 #ahj-;day exclusivity period amendments regarding first applicant status4 ,sec4 #djc4 #ahj-;day exclusivity period amendments regarding agreements to defer commercial marketing4 ,sec4 #djd4 ,increasing drug competition and preventing drug shortages4 ,sec4 #dje4 ,disallowance of deduction for advertising for prescription drugs4 ,sec4 #djf4 ,drug manufacturer duty to disclose drug prices to practitioners4 ,sec4 #djg4 ,excluding authorized generic drugs from calculation of average manufacturer price under the ,medicaid drug rebate program4 ,i ,transparency #aja4 ,drug manufacturer reporting ,part ,p of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is amended by adding at the end the following3 #cii,v-#g4 ,drug manufacturer reporting 7a7 ,definitions ,in this section3 7#a7 ,independent charity patient assistance program ,the term independent charity patient assistance program means any organization described in section #eja7;c77#c7 of the ,internal ,revenue ,code of #aihf and exempt from taxation under section #eja7;a7 of such ,code and which is not a private foundation 7as defined in section #eji7;a7 of such ,code7 that offers patient assistance4 7#b7 ,manufacturer patient assistance program ,the term manufacturer patient assistance program means an organization1 including a private foundation 7as so defined71 that is sponsored by1 or receives funding from1 a manufacturer and that offers patient assistance4 ,such term does not include an independent charity patient assistance program4 7#c7 ,patient assistance ,the term patient assistance means assistance provided to offset the cost of drugs for individuals4 ,such term includes free products1 coupons1 rebates1 copay or discount cards1 and other means of providing assistance to individuals related to drug costs1 as determined by the ,secretary4 7b7 ,reporting on domestic sales ,an applicable manufacturer of an approved drug 7including a drug approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act and a biological product licensed under subsection 7a7 or 7k7 of section #cea of this ,act7 shall submit to the ,secretary and to ,congress an annual report1 in such format as the ,secretary shall require1 outlining with respect to the previous calendar year 7except as provided in subsection 7c77#c77-- 7#a7 with respect to each such drug-- 7,a7 the total expenditures of the manufacturer on-- 7i7 domestic and foreign drug research and development1 including an itemized description of-- 7,i7 basic and preclinical research2 7,,ii7 clinical research1 broken out by clinical trial phase2 7,,iii7 development of alternative dosage forms and strengths for the drug molecule or combinations1 including the molecule2 7,,iv7 other drug development activities1 such as nonclinical laboratory studies and record and report maintenance2 7,v7 pursuing new or expanded indications for such drug through supplemental applications under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7,,vi7 carrying out postmarket requirements related to such drug1 including under section #eje7o77#c7 of such ,act2 7,,vii7 carrying out risk evaluation and mitigation strategies in accordance with section #eje-a of such ,act2 and 7,,viii7 marketing research2 7ii7 cost of goods sold1 broken out by source and cost of each component and identifying specific costs that reflect internal transfers within the manufacturer's company2 7iii7 acquisition costs in total and per unit sold1 including costs for the purchase of patents and licensing2 and 7iv7 marketing and advertising for the promotion of the drug1 including a breakdown of amounts aimed at consumers1 prescribers1 managed care organizations1 and others2 7,b7 the gross revenue1 net revenue1 gross profit1 and net profit to the manufacturer2 7,c7 the total number of units of the prescription drug that were sold in interstate commerce in the most recently completed calendar year2 7,d7 pricing information1 including-- 7i7 wholesale acquisition cost2 7ii7 net average price realized by pharmacy benefit managers for drugs provided to individuals in the ,united ,states1 after accounting for any rebates or other payments from the manufacturer to the pharmacy benefit manager and from the pharmacy benefit manager to the manufacturer2 and 7iii7 the net price of the drug1 after accounting for discounts1 rebates1 or other financial considerations1 charged to purchasers in each applicable country of the ,organisation for ,economic ,co-operation and ,development2 7,e7 information1 including the dollar value to the recipient of manufacturer patient assistance programs offered by the manufacturer or a manufacturer patient assistance program sponsored by or associated with the manufacturer1 per patient1 including-- 7i7 the specific forms of such patient assistance available1 such as coupons1 rebates1 discount codes1 or copayment cards2 7ii7 the total dollar value of each manufacturer patient assistance program and the dollar value of each program to the patient1 including the basis used to assign value to the manufacturer patient assistance program2 7iii7 the duration of each type of such patient assistance available2 and 7iv7 any requirements1 such as income thresholds1 for how to qualify for such patient assistance2 7,f7 information on usage of patient assistance offered by the manufacturer or a manufacturer patient assistance program sponsored by or associated with the manufacturer1 including-- 7i7 the number of transactions of each type of patient assistance used2 7ii7 the number of individuals receiving each type of patient assistance2 7iii7 the total value of each type of patient assistance that was used2 7iv7 the average length of time that each individual received each type of patient assistance2 7v7 the number of individuals who were discontinued from receiving each type of patient assistance2 and 7vi7 complete documentation of the terms and conditions for an individual agreeing to participate in the program for each type of patient assistance provided2 7,g7 any ,federal benefits received by the manufacturer1 including the amounts and periods of impact for each such benefit1 including tax credits1 patent applications that benefited from a ,federal grant1 patent extensions1 exclusivity periods1 and other ,federal benefits with respect to such drug2 and 7,h7 the percentage of research and development expenditures on-- 7i7 activities conducted by the manufacturer2 7ii7 activities funded by ,federal entities2 and 7iii7 activities conducted by other entities such as academic institutions or other drug manufacturers2 7#b7 executive compensation for the chief executive officer1 chief financial officer1 and the three other most highly compensated executive officers1 including bonuses1 paid by such manufacturer1 and stock options affiliated with the manufacturer that were offered to or accrued by such officers2 7#c7 any additional information the manufacturer chooses to provide related to drug pricing decisions1 such as total expenditures on drug research1 drug development1 and clinical trials on drugs that failed to receive approval by the ,food and ,drug ,administration1 a list of drugs and drug prices against which the manufacturer compared the applicable drug1 and other relevant information2 and 7#d7 any other information as the ,secretary may require4 7c7 ,submission of reports 7#a7 ,in general 7,a7 ,submission by drug manufacturers ,drug manufacturers shall submit the annual reports required under this section submitted to the ,secretary in a usable format1 as the ,secretary may require4 7,b7 ,collation by the ,secretary ,the ,secretary shall collate the reports received as described in subparagraph 7,a7 and submit such collated reports to ,congress1 together with an analysis of the reports by the ,secretary that includes-- 7i7 a summary of data from the reports2 7ii7 consideration of factors such as trends on research and development costs1 ,federal benefits1 and manufacturer patient assistance programs2 and 7iii7 the relationship between the factors described in clause 7ii7 and prescription drug prices4 7,c7 ,public availability ,the ,secretary shall make the reports submitted by manufacturers as described in subparagraph 7,a7 and the collated reports together with the analysis of the ,secretary described in subparagraph 7,b7 publicly available1 including by posting such reports to the internet website of the ,department of ,health and ,human ,services1 in a searchable format4 ,in publicizing such reports1 the ,secretary may redact such proprietary information as the ,secretary determines appropriate4 7#b7 ,single reports ,a drug manufacturer shall submit all information required under subsection 7b7 with respect to each applicable drug1 in a single1 annual report4 7#c7 ,initial report 7,a7 ,in general ,an applicable drug manufacturer shall submit a report pursuant to this section one year after the date of enactment of the ,affordable ,medications ,act 7except as provided in subparagraph 7,b77 that includes the information required under subsection 7b77#a7 with respect to each calendar year since the drug for which the report is required was approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 licensed under section #cea of this ,act1 or received an exemption under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea7;a77#c7 of this ,act1 or the calendar year in which the manufacturer acquired the drug4 7,b7 ,small businesses ,in the case of an applicable drug manufacturer that has fewer than #ejj employees1 the initial report described in subparagraph 7,a7 shall be submitted by a date determined by the ,secretary1 which shall be not earlier than the date described in subparagraph 7,a7 and not later than the date that is #c years after the date of enactment of the ,affordable ,medications ,act4 7d7 ,penalty for noncompliance ,the ,secretary shall report to the ,office of the ,inspector ,general any manufacturer's failure to submit a complete report as required under this section4 ,any manufacturer that fails to submit a complete report required under this section shall be subject to a civil penalty of up to #bjj1jjj for each day on which the violation continues4 ,the ,secretary shall collect the civil penalties under this subsection1 and without further appropriation1 shall use such funds to support the programs under sections #dji,k and #dhe;,e1 and1 at the discretion of the ,secretary1 research of the ,national ,institutes of ,health and other activities authorized under the ,affordable ,medications ,act1 including any amendments made by such ,act4 4 #ajb4 ,determining the public and private benefit of copayment coupons and other patient assistance programs 7a7 ,information reporting by independent charity patient assistance programs ,section #fjcc7;b7 of the ,internal ,revenue ,code of #aihf is amended by striking the period at the end of paragraph 7#af7 and inserting 1 and and by inserting after paragraph 7#af7 the following new paragraph3 7#ag7 the total amount of patient assistance 7within the meaning of section #cii,v-#g of the ,public ,health ,service ,act7 provided to individuals who are prescribed drugs manufactured by any contributor to the organization4 4 7b7 ,,gao study and report on impact of copayment coupons and other patient assistance programs on prescription drug pricing and expenditures 7#a7 ,study ,the ,comptroller ,general of the ,united ,states shall conduct a study on the impact of copayment coupons and other patient assistance programs on prescription drug pricing and expenditures4 ,such study shall include an analysis of the following3 7,a7 ,the extent to which copayment coupons and patient assistance programs contribute to inflated prescription drug prices and health insurance premiums1 including with respect to-- 7i7 the ,medicaid program under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq472 7ii7 the ,medicare program under title ,,xviii of such ,act 7#db ,u4,s4,c4 #acie et seq472 7iii7 the ,,tricare program under chapter #ee of title #aj1 ,united ,states ,code2 7iv7 health care under the laws administered by the ,secretary of ,veterans ,affairs2 7v7 the commercial health insurance market2 and 7vi7 the cash pay health market4 7,b7 ,the extent to which manufacturers offering copayment coupons and other patient assistance programs or sponsoring manufacturer patient assistance programs report obtaining tax deductions for offering or sponsoring such assistance 7either as business expenses or charitable deductions71 including-- 7i7 the total reported value of the tax deductions claimed by manufacturers for offering or sponsoring patient assistance programs during the #aj years preceding the date of enactment of this ,act2 7ii7 a description of the methodology manufacturers reported for assigning a value to the tax deduction claimed by manufacturers for offering or sponsoring patient assistance programs2 and 7iii7 a description of the extent to which the activities of independent charity patient assistance programs1 which are sponsored by1 or receive funding from1 pharmaceutical manufacturers 7as determined using tax returns1 sales data1 and other public disclosures7 provide a financial benefit to the manufacturers that sponsor them4 7,c7 ,oversight that is conducted to ensure that independent charity patient assistance programs adhere to guidance from the ,office of the ,inspector ,general of the ,department of ,health and ,human ,services on avoiding waste1 fraud1 and abuse4 7#b7 ,definitions ,in this subsection1 the terms 8patient assistance01 8independent charity patient assistance program01 8manufacturer01 and 8manufacturer patient assistance program0 have the meaning given those terms under section #cii,v-#g of the ,public ,health ,service ,act1 as added by section #aja4 7#c7 ,report ,not later than #b years after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report describing the findings of the study required under this subsection4 ,,ii ,access and ,affordability #bja4 ,negotiating fair prices for ,medicare prescription drugs 7a7 ,negotiating fair prices 7#a7 ,in general ,section #ahfj;,d-#aa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7 is amended by striking subsection 7i7 7relating to noninterference7 and by inserting the following3 7i7 ,negotiating fair prices with drug manufacturers 7#a7 ,in general ,notwithstanding any other provision of law1 in furtherance of the goals of providing quality care and containing costs under this part1 the ,secretary shall1 with respect to applicable covered part ,d drugs1 and may1 with respect to other covered part ,d drugs1 negotiate1 using the negotiation technique or techniques that the ,secretary determines will maximize savings and value to the government for prescription drug plans and ,,ma-,,pd plans and for plan enrollees 7in a manner that may be similar to ,federal entities and that may include1 but is not limited to1 formularies1 reference pricing1 discounts1 rebates1 other price concessions1 and coverage determinations71 with drug manufacturers the prices that may be charged to ,,pdp sponsors and ,,ma organizations for such drugs for part ,d eligible individuals who are enrolled in a prescription drug plan or in an ,,ma-,,pd plan4 ,in conducting such negotiations1 the ,secretary shall consider the drug's current price1 initial launch price1 prevalence of disease and usage1 and approved indications1 the number of similarly effective alternative treatments for each approved use of the drug1 the budgetary impact of providing coverage under this part for such drug for all individuals who would likely benefit from the drug1 evidence on the drug's effectiveness and safety compared to similar drugs1 and the quality and quantity of clinical data and rigor of the applicable process of approval of a drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or a biological product under section #cea of the ,public ,health ,service ,act4 7#b7 ,use of lower of ,,va or big four price if negotiations fail ,if1 after attempting to negotiate for a price with respect to a covered part ,d drug under paragraph 7#a7 for a period of #a year1 the ,secretary is not successful in obtaining an appropriate price for the drug 7as determined by the ,secretary71 the ,secretary shall establish the price that may be charged to ,,pdp sponsors and ,,ma organizations for such drug for part ,d eligible individuals who are enrolled in a prescription drug plan or in an ,,ma-,,pd plan at an amount equal to the lesser of-- 7,a7 the price paid by the ,secretary of ,veterans ,affairs to procure the drug under the laws administered by the ,secretary of ,veterans ,affairs2 or 7,b7 the price paid to procure the drug under section #habf of title #ch1 ,united ,states ,code4 7#c7 ,applicable covered part ,d drug defined ,for purposes of this subsection1 the term applicable covered part ,d drug means a covered part ,d drug that the ,secretary determines to be appropriate for negotiation under paragraph 7#a7 based on one or more of the following factors as applied to such drug3 7,a7 ,spending on a per beneficiary basis4 7,b7 ,the proportion of total spending under this title4 7,c7 ,unit price increases over the preceding #e years4 7,d7 ,initial launch price4 7,e7 ,availability of less expensive1 similarly effective alternative treatments4 7,f7 ,status of the drug as a follow-on to previously approved drugs4 7,g7 ,any other criteria determined by the ,secretary4 7#d7 ,,pdp sponsors and ,,ma organization may negotiate lower prices ,nothing in this subsection shall be construed as preventing the sponsor of a prescription drug plan1 or an organization offering an ,,ma-,,pd plan1 from obtaining a discount or reduction of the price for a covered part ,d drug below the price negotiated under paragraph 7#a7 or the price established under paragraph 7#b74 7#e7 ,no effect on existing appeals process ,nothing in this subsection shall be construed to affect the appeals procedures under subsections 7g7 and 7h7 of section #ahfj;,d-#d4 4 7#b7 ,effective date ,the amendments made by this subsection shall take effect on the date of the enactment of this ,act and shall first apply to negotiations and prices for plan years beginning on ,january #a1 #bjbj4 7b7 ,requirement ,to include a link to the ,medicare ,drug ,spending ,dashboard on the ,medicare ,plan ,finder ,beginning not later than ,january #a1 #bjbj1 the ,secretary of ,health and ,human ,services shall ensure that the ,medicare ,plan ,finder on the ,medicare4gov internet website includes a link to the ,medicare ,drug ,spending ,dashboard on the ,,cms4gov internet website4 ,such link shall be easily accessible on the ,medicare ,plan ,finder4 7c7 ,reports to ,congress 7#a7 ,secretary of ,,hhs 7,a7 ,in general ,not later than #c years after the date of the enactment of this ,act1 and every #f months thereafter1 the ,secretary of ,health and ,human ,services shall submit to ,congress a report on the following3 7i7 ,the price negotiations conducted by the ,secretary under section #ahfj;,d-#aa7;i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;i771 as amended by subsection 7a71 including a description of-- 7,i7 how such price negotiations are achieving lower prices for covered part ,d drugs 7as defined in section #ahfj;,d-#b7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;e777 for ,medicare beneficiaries2 7,,ii7 how such lower prices are passed through to ,medicare beneficiaries2 7,,iii7 how such price negotiations are affecting drug prices in the private market2 and 7,,iv7 how such price negotiations are affecting the list price of covered part ,d drugs4 7ii7 ,data on spending under part ,d of the ,medicare program on covered part ,d drugs1 including data on covered part ,d drugs with-- 7,i7 spending on a per beneficiary basis that is above the median spending on other drugs in the same class or above the median spending of other drug classes2 and 7,,ii7 high unit cost increases over the past five years1 especially where such increases are greater than the increases for covered part ,d drugs in general4 7iii7 ,a list of the covered part ,d drugs with no therapeutic substitute and data on spending under part ,d of the ,medicare program on such drugs4 7iv7 ,access to covered part ,d drugs and1 where available1 compliance rates and health outcomes associated with compliance rates4 7v7 ,appeals by enrollees with respect to covered part ,d drugs not included on plan formularies4 7,b7 ,public availability of report ,the ,secretary of ,health and ,human ,services shall publish on the internet website of the ,centers for ,medicare ,medicaid ,services a copy of each report submitted under subparagraph 7,a71 including the detailed tables1 figures1 and data published in the report and its appendices4 7#b7 ,med,p,a,c 7,a7 ,study ,the ,comptroller ,general of the ,united ,states shall conduct a study on the price negotiations conducted by the ,secretary under section #ahfj;,d-#aa7;i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;i771 as amended by subsection 7a71 including an analysis of-- 7i7 how such price negotiations are achieving lower prices for covered part ,d drugs 7as defined in section #ahfj;,d-#b7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;e777 for ,medicare beneficiaries2 7ii7 who is benefiting from such lower prices1 such as ,medicare beneficiaries1 the ,federal ,government1 ,states1 prescription drug plans and ,,ma-,,pd plans1 or other entities2 7iii7 how such price negotiations are a factor affecting drug prices in the private market2 and 7iv7 how such price negotiations are a factor affecting the list price of covered part ,d drugs4 7,b7 ,report ,not later than ,january #a1 #bjbb1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report on the study conducted under subparagraph 7,a71 together with recommendations for improving such price negotiations4 7d7 ,,cmi testing of negotiating drug and biological prices ,to improve value ,section #aaae;,a7b77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acae;a7b77#b77 is amended-- 7#a7 in subparagraph 7,a71 by adding at the end the following new sentence3 ,the models selected under this subparagraph shall include at least three of the models described in subparagraph 7,d71 which shall be implemented by not later than #ah months after the date of the enactment of the ,affordable ,medications ,act2 and 7#b7 by adding at the end the following new subparagraph3 7,d7 ,models of negotiating drug and biological prices to improve value ,the models described in this subparagraph are the following models for negotiating drug and biological prices under the applicable titles 7including under both parts ,b and ,d of title ,,xviii7 in order to improve the value of payments for such drugs and biologicals under such titles3 7i7 ,discounting or eliminating patient cost-sharing on high-value drugs and biologicals4 7ii7 ,value-based formularies4 7iii7 ,indications-based pricing4 7iv7 ,reference pricing4 7v7 ,risk-sharing agreements based on outcomes4 7vi7 ,pricing based on comparative effectiveness research4 7vii7 ,episode-based payments for chemotherapy and other conditions determined appropriate by the ,secretary4 7viii7 ,alternative ways of paying for drugs and biologicals under part ,b of title ,,xviii4 7ix7 ,other models determined appropriate by the ,secretary4 4 #bjb4 ,prescription drug price spikes 7a7 ,identification of prescription drug price spikes 7#a7 ,definitions ,in this subsection3 7,a7 ,applicable entity ,the term applicable entity means the holder of an application approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or of a license issued under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 for a drug described in paragraph 7#e77;,a74 7,b7 ,average manufacturer price ,the term average manufacturer price-- 7i7 has the same meaning given such term under section #aibg7k77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#a772 or 7ii7 with respect to a drug for which there is no average manufacturer price as so defined1 such term shall mean the wholesale acquisition cost of the drug4 7,c7 ,commerce ,the term commerce has the meaning given such term in section #d of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #dd74 7,d7 ,inspector ,general ,the term ,inspector ,general means the ,inspector ,general of the ,department of ,health and ,human ,services4 7,e7 ,prescription drug 7i7 ,in general ,the term prescription drug means any drug 7as defined in section #bja7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g7771 including a combination product whose primary mode of action is determined under section #ejc7;g7 of such ,act 7#ba ,u4,s4,c4 #cec7;g77 to be that of a drug1 and that-- 7,i7 is subject to section #ejc7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;b77#a772 and 7,,ii7 is covered by a ,federal health care program 7as defined in section #aabh;,b7f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b7f7774 7ii7 ,treatment of reformulated drugs ,for purposes of this subsection1 a prescription drug with respect to which the ,secretary of ,health and ,human ,services has approved any minor reformulation that does not produce a meaningful therapeutic benefit1 the drug that was approved prior to any such reformulation and the drug with any such reformulation shall be considered one prescription drug4 7,f7 ,price spike 7i7 ,in general ,the term price spike means an increase in the average manufacturer price in commerce of a prescription drug for which the price spike percentage is equal to or greater than applicable price increase allowance4 7ii7 ,price spike percentage ,the price spike percentage is the percentage 7if any7 by which-- 7,i7 the average manufacturer price of a prescription drug in commerce for the calendar year2 exceeds 7,,ii7 the average manufacturer price of such prescription drug in commerce for the calendar year preceding such year4 7iii7 ,applicable price increase allowance ,the applicable price increase allowance for any calendar year is the percentage 7rounded to the nearest one-tenth of #a percent7 by which the ,c-,,cpi-,u 7as defined in section #a7;f77#f7 of the ,internal ,revenue ,code of #aihf7 for that year exceeds the ,c-,,cpi-,u for the preceding calendar year4 7,g7 ,price spike revenue 7i7 ,in general ,the price spike revenue for any calendar year is an amount equal to-- 7,i7 the gross price spike revenue2 minus 7,,ii7 the adjustment amount4 7ii7 ,gross price spike revenue ,the gross price spike revenue for any calendar year is an amount equal to the product of-- 7,i7 an amount equal to the difference between subclause 7,i7 of subparagraph 7,f77ii7 and subclause 7,,ii7 of such subparagraph2 and 7,,ii7 the total number of units of the prescription drug which were sold in commerce in such calendar year4 7iii7 ,adjustment amount ,the adjustment amount is the amount1 if any1 of the gross price spike revenue which the ,inspector ,general has determined is due solely to an increase in the cost of the inputs necessary to manufacture the prescription drug subject to the price spike4 7#b7 ,submission by pharmaceutical companies of information to ,inspector ,general 7,a7 ,in general ,for each prescription drug1 the applicable entity shall submit to the ,inspector ,general a quarterly report that includes the following3 7i7 ,for each prescription drug of the applicable entity-- 7,i7 the total number of units of the prescription drug which were sold in commerce in the preceding calendar quarter2 7,,ii7 the average and median price per unit of such prescription drug in commerce in the preceding calendar quarter1 disaggregated by month2 and 7,,iii7 the gross revenues from sales of such prescription drug in commerce in the preceding calendar quarter4 7ii7 ,such information related to increased input costs or public health considerations as the applicable entity may wish the ,inspector ,general to consider in making a determination under subclause 7,,ii7 of paragraph 7#c77;,b77ii7 or an assessment in subclause 7,,iii7 of such paragraph for the preceding calendar quarter4 7iii7 ,such information related to any anticipated increased input costs for the subsequent calendar quarter as the applicable entity may wish the ,inspector ,general to consider in making a determination under subclause 7,,ii7 of paragraph 7#c77;,b77ii7 or an assessment in subclause 7,,iii7 of such paragraph for such calendar quarter4 7,b7 ,penalty for failure to submit 7i7 ,in general ,an applicable entity described in subparagraph 7,a7 that fails to submit information to the ,inspector ,general regarding a prescription drug1 as required by such subparagraph1 before the date specified in subparagraph 7,c7 shall be liable for a civil penalty1 as determined under clause 7ii74 7ii7 ,amount of penalty ,the amount of the civil penalty shall be equal to the product of-- 7,i7 an amount1 as determined appropriate by the ,inspector ,general1 which is-- 7aa7 not less than #j4e percent of the gross revenues from sales of the prescription drug described in clause 7i7 for the preceding calendar year1 and 7bb7 not greater than #a percent of the gross revenues from sales of such prescription drug for the preceding calendar year1 and 7,,ii7 the number of days in the period between-- 7aa7 the applicable date specified in subparagraph 7,c71 and 7bb7 the date on which the ,inspector ,general receives the information described in subparagraph 7,a7 from the applicable entity4 7,c7 ,submission deadline ,an applicable entity shall submit each quarterly report described in subparagraph 7,a7 not later than ,january #ag1 ,april #ah1 ,june #ae1 and ,september #ae of each calendar year4 7#c7 ,assessment by ,inspector ,general 7,a7 ,in general ,not later than the last day in ,february of each year1 the ,inspector ,general1 in consultation with other relevant ,federal agencies 7including the ,federal ,trade ,commission71 shall-- 7i7 complete an assessment of the information the ,inspector ,general received pursuant to paragraph 7#b77;,a7 with respect to sales of prescription drugs in the preceding calendar year2 and 7ii7 in the case of any prescription drug which satisfies the conditions described in subparagraph 7,a7 or 7,b7 of paragraph 7#d71 submit a recommendation to the ,secretary of ,health and ,human ,services that such drug be exempted from application of the tax imposed under section #daib of the ,internal ,revenue ,code of #aihf 7as added by subsection 7b7 of this section7 for such year4 7,b7 ,elements ,the assessment required by subparagraph 7,a7 shall include the following3 7i7 ,identification of each price spike relating to a prescription drug in the preceding calendar year4 7ii7 ,for each price spike identified under clause 7i7-- 7,i7 a determination of the price spike revenue2 7,,ii7 a determination regarding the accuracy of the information submitted by the applicable entity regarding increased input costs2 and 7,,iii7 an assessment of the rationale of the applicable entity for the price spike4 7#d7 ,exemption of certain drugs 7,a7 ,in general ,the ,secretary of ,health and ,human ,services1 upon recommendation of the ,inspector ,general pursuant to paragraph 7#c77;,a77ii71 may exempt any prescription drug which has been subject to a price spike during the preceding calendar year from application of the tax imposed under section #daib of the ,internal ,revenue ,code of #aihf for such year1 if the ,secretary determines that-- 7i7 based on information submitted pursuant to paragraph 7#b77;,a77ii71 a for-cause price increase exemption should apply2 or 7ii7 7,i7 the prescription drug which has been subject to a price spike has an average manufacturer price of not greater than #aj for a #cj-;day supply2 and 7,,ii7 such drug is marketed by not less than three other holders of applications approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 where such applications approved under such subsection 7j7 use as a reference drug the drug so approved under such subsection 7c74 7,b7 ,clarification ,in considering1 under subparagraph 7,a77i71 information submitted pursuant to paragraph 7#b77;,a77ii71 the ,secretary-- 7i7 has the discretion to determine that such information does not warrant a for-cause price increase exemption2 and 7ii7 shall exclude from such consideration any information submitted by the applicable entity threatening to curtail or limit production of the prescription drug if the ,secretary does not grant an exemption from the application of the tax under section #daib of the ,internal ,revenue ,code of #aihf4 7#e7 ,inspector ,general report to ,internal ,revenue ,service 7,a7 ,in general ,subject to subparagraph 7,c71 not later than the last day in ,february of each year1 the ,inspector ,general shall transmit to the ,internal ,revenue ,service a report on the findings of the ,inspector ,general with respect to the information the ,inspector ,general received under paragraph 7#b77;,a7 with respect to the preceding calendar year and the assessment carried out by the ,inspector ,general under paragraph 7#c77;,a7 with respect to such information4 7,b7 ,contents ,the report transmitted under subparagraph 7,a7 shall include the following3 7i7 ,the information received under paragraph 7#b77;,a7 with respect to the preceding calendar year4 7ii7 ,the price spikes identified under clause 7i7 of paragraph 7#c77;,b74 7iii7 ,the price spike revenue determinations made under clause 7ii77,i7 of such paragraph4 7iv7 ,the determinations and assessments made under subclauses 7,,ii7 and 7,,iii7 of clause 7ii7 of such paragraph4 7,c7 ,notice and opportunity for hearing 7i7 ,in general ,no report shall be transmitted to the ,internal ,revenue ,service under subparagraph 7,a7 in regards to a prescription drug unless the ,inspector ,general has provided the applicable entity with-- 7,i7 the assessment of such drug under paragraph 7#c77;,a72 and 7,,ii7 notice of their right to a hearing in regards to such assessment4 7ii7 ,notice ,the notice required under clause 7i7 shall be provided to the applicable entity not later than #cj days after completion of the assessment under paragraph 7#c77;,a74 7iii7 ,request for hearing ,subject to clause 7v71 an applicable entity may request a hearing before the ,secretary of ,health and ,human ,services not later than #cj days after the date on which the notice under clause 7ii7 is received4 7iv7 ,completion of hearing ,in the case of an applicable entity which requests a hearing pursuant to clause 7iii71 the ,secretary of ,health and ,human ,services shall1 not later than #ab months after the date on which the assessment under paragraph 7#c77;,a7 was completed by the ,inspector ,general-- 7,i7 make a final determination in regards the accuracy of such assessment2 and 7,,ii7 provide the report described in subparagraph 7,b7 to the ,internal ,revenue ,service4 7v7 ,limitation ,an applicable entity may request a hearing under clause 7iii7 with respect to a particular prescription drug only once within a #e-year period4 7,d7 ,publication 7i7 ,in general ,not later than the last day in ,february of each year1 subject to clause 7ii71 the ,inspector ,general shall make the report transmitted under subparagraph 7,a7 available to the public1 including on the internet website of the ,inspector ,general4 7ii7 ,proprietary information ,the ,inspector ,general shall ensure that any information made public in accordance with clause 7i7 excludes trade secrets and confidential commercial information4 7#f7 ,notification ,the ,secretary of the ,treasury1 in conjunction with the ,inspector ,general1 shall notify1 at such time and in such manner as the ,secretary of the ,treasury shall provide1 each applicable entity in regard to any prescription drug which has been determined to have been subject to a price spike during the preceding calendar year and the amount of the tax imposed on such applicable entity pursuant to section #daib of the ,internal ,revenue ,code of #aihf4 7b7 ,excise tax on prescription drugs subject to price spikes 7#a7 ,in general ,subchapter ,e of chapter #cb of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new section3 #daib4 ,prescription drugs subject to price spikes 7a7 ,imposition of tax 7#a7 ,in general ,subject to paragraph 7#c71 for each taxable prescription drug sold by an applicable entity during the calendar year1 there is hereby imposed on such entity a tax equal to the greater of-- 7,a7 the annual price spike tax for such prescription drug1 or 7,b7 subject to paragraph 7#b71 the cumulative price spike tax for such prescription drug4 7#b7 ,limitation ,in the case of a taxable prescription drug for which the applicable period 7as determined under subsection 7c77#b77;,e77i77 is less than #b calendar years1 the cumulative price spike tax shall not apply4 7#c7 ,exemption ,for any calendar year in which the ,secretary of ,health and ,human ,services has provided an exemption for a taxable prescription drug pursuant to section #bjb7;a77#d7 of the ,affordable ,medications ,act1 the amount of the tax determined under paragraph 7#a7 for such drug or device for such calendar year shall be reduced to zero4 7b7 ,annual price spike tax 7#a7 ,in general ,the amount of the annual price spike tax shall be equal to the applicable percentage of the price spike revenue received by the applicable entity on the sale of the taxable prescription drug during the calendar year4 7#b7 ,applicable percentage ,for purposes of paragraph 7#a71 the applicable percentage shall be equal to-- 7,a7 in the case of a taxable prescription drug which has been subject to a price spike percentage greater than the applicable price increase allowance 7as defined in section #bjb7;a77#a77;,f77iii7 of the ,affordable ,medications ,act7 but less than #ae percent1 #ej percent1 7,b7 in the case of a taxable prescription drug which has been subject to a price spike percentage equal to or greater than #ae percent but less than #bj percent1 #ge percent1 and 7,c7 in the case of a taxable prescription drug which has been subject to a price spike percentage equal to or greater than #bj percent1 #ajj percent4 7c7 ,cumulative price spike tax 7#a7 ,in general ,the amount of the cumulative price spike tax shall be equal to the applicable percentage of the cumulative price spike revenue received by the applicable entity on the sale of the taxable prescription drug during the calendar year4 7#b7 ,applicable percentage 7,a7 ,in general ,for purposes of paragraph 7#a71 the applicable percentage shall be equal to-- 7i7 in the case of a taxable prescription drug which has been subject to a cumulative price spike percentage greater than the cumulative price increase allowance but less than the first multi-year percentage1 #ej percent1 7ii7 in the case of a taxable prescription drug which has been subject to a cumulative price spike percentage equal to or greater than the first multi-year percentage but less than the second multi-year percentage1 #ge percent1 and 7iii7 in the case of a taxable prescription drug which has been subject to a cumulative price spike percentage equal to or greater than the second multi-year percentage1 #ajj percent4 7,b7 ,cumulative price spike percentage ,the cumulative price spike percentage is the percentage 7if any7 by which-- 7i7 the average manufacturer price of the taxable prescription drug in commerce for the preceding calendar year1 exceeds 7ii7 the average manufacturer price of such prescription drug in commerce for the base year4 7,c7 ,cumulative price increase allowance ,for purposes of clause 7i7 of subparagraph 7,a71 the cumulative price increase allowance for any calendar year is the percentage 7rounded to the nearest one-tenth of #a percent7 by which the ,c-,,cpi-,u 7as defined in section #a7;f77#f77 for that year exceeds the ,c-,,cpi-,u for the base year4 7,d7 ,multi-year percentages ,for purposes of subparagraph 7,a71 the first multi-year percentage and second multi-year percentage shall be determined in accordance with the following table3 ,number of years in applicable period,first multi-year percentage,second multi-year percentage#b years#ag4ebb4ec years#bjbed years#bb4ebg4ee years#becj4 7,e7 ,applicable period and base year 7i7 ,applicable period ,the applicable period shall be the lesser of-- 7,i7 the #e preceding calendar years1 7,,ii7 all calendar years beginning after the date of enactment of this section1 or 7,,iii7 all calendar years in which the taxable prescription drug was sold in commerce4 7ii7 ,base year ,the base year shall be the calendar year immediately preceding the applicable period4 7#c7 ,cumulative price spike revenue ,for purposes of paragraph 7#a71 the cumulative price spike revenue for any taxable prescription drug shall be an amount equal to-- 7,a7 an amount equal to the product of-- 7i7 an amount 7not less than zero7 equal to-- 7,i7 the average manufacturer price of such prescription drug in commerce for the preceding calendar year1 minus 7,,ii7 the average manufacturer price of such prescription drug in commerce for the base year1 and 7ii7 the total number of units of such prescription drug which were sold in commerce in the preceding calendar year1 minus 7,b7 an amount equal to the sum of the adjustment amounts1 if any1 determined under section #bjb7;a77#a77;,g77iii7 of the ,affordable ,medications ,act for each calendar year during the applicable period4 7d7 ,definitions ,for purposes of this section-- 7#a7 ,taxable prescription drug ,the term taxable prescription drug means a prescription drug 7as defined in section #bjb7;a77#a77;,e7 of the ,affordable ,medications ,act7 which has been identified by the ,inspector ,general of the ,department of ,health and ,human ,services1 under section #bjb7;a77#c77;,b77i7 of such ,act1 as being subject to a price spike4 7#b7 ,other terms ,the terms applicable entity1 average manufacturer price1 price spike1 price spike percentage1 and price spike revenue have the same meaning given such terms under section #bjb7;a77#a7 of the ,affordable ,medications ,act4 4 7#b7 ,clerical amendments 7,a7 ,the heading of subchapter ,e of chapter #cb of the ,internal ,revenue ,code of #aihf is amended by striking ,medical devices and inserting ,certain medical devices and prescription drugs4 7,b7 ,the table of subchapters for chapter #cb of such ,code is amended by striking the item relating to subchapter ,e and inserting the following new item3 ,subchapter ,e4 ,certain medical devices and prescription drugs 4 7#c7 ,the table of sections for subchapter ,e of chapter #cb of such ,code is amended by adding at the end the following new item3 ,sec4 #daib4 ,prescription drugs subject to price spikes4 4 7#d7 ,effective date ,the amendments made by this section shall apply to sales after the date of the enactment of this ,act4 7c7 ,revenues collected ,there are authorized to be appropriated to the ,secretary of ,health and ,human ,services such sums as are equal to any increase in revenue to the ,treasury by reason of the provisions of this section or the amendments made by this section for the purposes of-- 7#a7 funding or conducting research on the economic and policy implications of price patterns of prescription drugs2 7#b7 increasing amounts available to the ,national ,institutes of ,health for research and development of drugs2 7#c7 reducing prescription drug cost-sharing for patients2 or 7#d7 reducing health insurance premiums4 #bjc4 ,importing affordable and safe drugs 7a7 ,in general ,section #hjd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd7 is amended to read as follows3 #hjd4 ,importation of safe and affordable drugs by wholesale distributors1 pharmacies1 and individuals 7a7 ,in general ,not later than #ahj days after the date of enactment of the ,affordable ,medications ,act1 the ,secretary shall promulgate regulations permitting the importation of qualifying prescription drugs into the ,united ,states1 in accordance with this section4 7b7 ,definitions ,for purposes of this section3 7#a7 ,certified foreign seller ,the term certified foreign seller means a licensed foreign pharmacy or foreign wholesale distributor that the ,secretary certifies under subsection 7d77#a77;,b71 that pays the fee required under subsection 7d77#a77;,c71 and that is included on the list described in subsection 7c74 7#b7 ,foreign wholesale distributor ,the term foreign wholesale distributor means a person 7other than a manufacturer1 a manufacturer's co-licensed partner1 a third-party logistics provider1 or a repackager7 engaged in wholesale distribution4 7#c7 ,importer ,the term importer means a dispenser 7as defined in section #eha7c77 or wholesale distributor registered under section #ejc7;e7 who imports prescription drugs into the ,united ,states in accordance with this section4 7#d7 ,licensed foreign pharmacy ,the term licensed foreign pharmacy means a pharmacy located in ,canada1 or subject to subsection 7e71 another applicable country1 that-- 7,a7 operates in accordance with applicable pharmacy standards set forth by the provincial pharmacy rules and regulations enacted in ,canada1 or1 subject to subsection 7e71 such applicable rules and regulations of the permitted country in which such seller is located2 and 7,b7 is licensed to operate and dispense prescription drugs to individuals in ,canada1 or1 subject to subsection 7e71 the permitted country in which the pharmacy is located4 7#e7 ,qualifying prescription drug ,the term qualifying prescription drug-- 7,a7 means a prescription drug that-- 7i7 is approved for use in patients1 and marketed1 in ,canada1 or subject to subsection 7e71 approved for use in patients1 and marketed1 in another permitted country2 7ii7 is manufactured in a facility registered under subsection 7b77#a7 or 7i7 of section #eaj that is in compliance with good manufacturing practices regulations of the ,food and ,drug ,administration2 7iii7 has the same active ingredient or ingredients1 route of administration1 and strength as a prescription drug approved under chapter ,v1 or1 for purposes of subparagraph 7,b77iv71 is biosimilar to an approved biological product and has the same route of administration and strength as the approved biological product2 and 7iv7 is labeled in accordance with-- 7,i7 the laws of ,canada1 or another country from which importation is permitted pursuant to subsection 7e72 and 7,,ii7 the requirements promulgated by the ,secretary1 which shall include labeling in ,english2 7,b7 with respect to importers only1 includes-- 7i7 peritoneal dialysis solution2 7ii7 insulin2 7iii7 a drug for which a risk evaluation and mitigation strategy is required under section #eje-a2 7iv7 biological products1 as defined in section #cea of the ,public ,health ,service ,act that are proteins 7except any chemically synthesized polypeptides7 or analogous products2 and 7v7 intravenously infused drugs2 and 7,c7 does not include-- 7i7 a controlled substance 7as defined in section #ajb of the ,controlled ,substances ,act72 7ii7 an anesthetic drug inhaled during surgery2 or 7iii7 a compounded drug4 7#f7 ,valid prescription ,the term valid prescription means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by-- 7,a7 a practitioner who has conducted at least one in-person medical evaluation of the patient2 or 7,b7 a covering practitioner4 7c7 ,publication of certified foreign sellers ,the ,secretary shall publish on a dedicated internet website a list of certified foreign sellers1 including the internet website address1 physical address1 and telephone number of each such certified foreign seller4 7d7 ,additional criteria 7#a7 ,certified foreign sellers 7,a7 ,in general ,to be a certified foreign seller1 such seller shall-- 7i7 be certified by the ,secretary in accordance with subparagraph 7,b72 7ii7 pay the registration fee established under subparagraph 7,c72 and 7iii7 sell only qualifying prescription drugs to importers or individuals who import prescription drugs into the ,united ,states in accordance with this section4 7,b7 ,certification ,to be a certified foreign seller1 the ,secretary shall certify that such seller-- 7i7 is a foreign wholesale distributor or licensed foreign pharmacy operating an establishment1 which may include an online foreign pharmacy1 that is located in ,canada1 or1 subject to subsection 7e71 another permitted country2 7ii7 is engaged in the distribution or dispensing of a prescription drug that is imported or offered for importation into the ,united ,states2 7iii7 has been in existence for a period of at least #e years preceding the date of such certification and has a purpose other than to participate in the program established under this section2 7iv7 in the case of a certified foreign seller that is a licensed foreign pharmacy1 agrees to dispense a qualifying prescription drug to an individual in the ,united ,states only after receiving a valid prescription1 as described in paragraph 7#b77;,c72 7v7 has processes established by the seller1 or participates in another established process1 to certify that the physical premises and data reporting procedures and licenses are in compliance with all applicable laws and regulations of ,canada1 or1 subject to subsection 7e71 the permitted country in which the seller is located1 and has implemented policies designed to monitor ongoing compliance with such laws and regulations2 7vi7 conducts or commits to participate in ongoing and comprehensive quality assurance programs and implements such quality assurance measures1 including blind testing1 to ensure the veracity and reliability of the findings of the quality assurance program2 7vii7 agrees that1 pursuant to subsection 7g71 laboratories approved by the ,secretary may be authorized to conduct product testing to determine the chemical authenticity of sample pharmaceutical products2 7viii7 agrees to notify the ,secretary1 importers1 and individuals of product recalls in ,canada1 or pursuant to subsection 7e71 the permitted country in which the seller is located1 and agrees to cease1 or refrain from1 exporting such product2 7ix7 has established1 or will establish or participate in1 a process for resolving grievances1 as defined by the ,secretary1 and will be held accountable for violations of established guidelines and rules2 7x7 except as otherwise permitted under this section1 does not sell products that the seller could not otherwise legally sell in ,canada1 or1 subject to subsection 7e71 the permitted country in which such seller is located to customers in the ,united ,states2 and 7xi7 meets any other criteria established by the ,secretary4 7,c7 ,certification fee ,not later than #cj days before the start of each fiscal year1 the ,secretary shall establish a fee to be collected from foreign sellers for such fiscal year that are certified under subparagraph 7,b71 in an amount that is sufficient1 and not more than necessary1 to pay the costs of administering the program under this section1 and enforcing this section pursuant to section #cjc7;h71 for that fiscal year4 7,d7 ,recertification ,a certification under subparagraph 7,b7 shall be in effect for a period of #b years1 or until there is a material change in the circumstances under which the foreign seller meets the requirements under such subparagraph1 whichever occurs earlier4 ,a foreign seller may reapply for certification under such subparagraph 7,b71 in accordance with a process established by the ,secretary4 7#b7 ,individuals ,an individual may import a qualifying prescription drug described in subsection 7b7 from ,canada or another country pursuant to subsection 7e7 if such drug-- 7,a7 is dispensed1 including through an online pharmacy1 by a certified foreign seller that is a licensed foreign pharmacy2 7,b7 is purchased for personal use by the individual1 not for resale1 in quantities that do not exceed a #ij-;day supply2 and 7,c7 is filled only after providing to the licensed foreign pharmacy a valid prescription issued by a health care practitioner licensed to practice in a ,state in the ,united ,states4 7e7 ,importation from other countries ,beginning on the date that is #b years after the date on which final regulations are promulgated to carry out this section1 if1 based on a review of the evidence obtained after such effective date1 including the reports submitted under section #b7;d7 of the ,affordable ,medications ,act1 that importation of qualifying prescription drugs from ,canada under this section resulted in cost savings for consumers in the ,united ,states and increased access to safe medication1 the ,secretary shall have the authority to permit importation of qualifying prescription drugs by importers and individuals from1 in addition to ,canada1 any country that-- 7#a7 is a member of the ,organisation for ,economic ,co-operation and ,development2 and 7#b7 has statutory or regulatory standards for the approval and sale of prescription drugs that are comparable to the standards in the ,united ,states and that-- 7,a7 authorizes the approval of drugs only if a drug has been determined to be safe and effective by experts employed by or acting on behalf of a governmental entity and qualified by scientific training and experience to evaluate the safety and effectiveness of drugs2 7,b7 requires that any determination of safety and effectiveness described in subparagraph 7,a7 be made on the basis of adequate and well-controlled investigations1 including clinical investigations1 as appropriate1 conducted by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs2 7,c7 requires the methods used in1 and the facilities and controls used for1 the manufacture1 processing1 and packing of drugs in the country to be adequate to preserve the identity1 quality1 purity1 and strength of the drugs2 and 7,d7 requires the reporting of adverse reactions to drugs and establish procedures to recall1 and withdraw approval of1 drugs found not to be safe or effective4 7f7 ,labeling ,any qualifying prescription drug imported that meets the labeling requirements described in subsection 7b77#e77;,a77iv7 is deemed not misbranded for purposes of section #ejb4 7g7 ,drug testing laboratories ,the ,secretary may approve one or more laboratories to conduct random testing of prescription drugs sold by certified foreign sellers to assess the chemical authenticity of such drugs4 7h7 ,unfair and discriminatory ,acts and practices ,it is unlawful for a manufacturer1 directly or indirectly 7including by being a party to a licensing agreement or other agreement7-- 7#a7 to discriminate by charging a higher price for a prescription drug sold to a certified foreign seller that sells such drug to an importer in accordance with this section than the price that is charged1 inclusive of rebates or other incentives to the country from which the drug is exported1 to another person that is in the same country and that does not import such a drug into the ,united ,states in accordance with this section2 7#b7 except with respect to a prescription drug on the drug shortage list under section #ejf;,e1 discriminate by denying1 restricting1 or delaying supplies of a prescription drug to a certified foreign seller1 on account of such seller's status as a certified foreign seller1 that sells such drug to an importer in accordance with this section1 or by publicly1 privately1 or otherwise refusing to do business with such a certified foreign seller on account of such seller's status as a certified foreign seller2 7#c7 cause there to be a difference 7including a difference in active ingredient1 route of administration1 bioequivalence1 strength1 formulation1 manufacturing establishment1 manufacturing process1 or person that manufactures the drug7 between a prescription drug for distribution in the ,united ,states and the drug for distribution in ,canada or another permitted country1 subject to subsection 7e71 for the purpose of avoiding sales by certified foreign sellers2 or 7#d7 except with respect to a prescription drug on the drug shortage list under section #ejf;,e1 engage in any other action to restrict1 prohibit1 or delay the importation of a prescription drug under this section4 7i7 ,information and records 7#a7 ,biannual reports ,each importer shall submit biannual reports to the ,secretary which shall contain1 for each qualifying prescription drug imported into the ,united ,states-- 7,a7 the unique facility identifier of the manufacturer of the drug1 described in section #eaj2 7,b7 the transaction information described in section #eha7bf7 7other than the information described in subparagraph 7,c772 and 7,c7 the price paid by the importer for the drug4 7#b7 ,maintenance of records by ,secretary ,the ,secretary shall maintain information and documentation submitted under paragraph 7#a7 for such period of time as the ,secretary determines to be appropriate4 7j7 ,suspension of importation 7#a7 ,patterns of noncompliance ,the ,secretary shall require that importation of a specific qualifying prescription drug or importation by a specific certified foreign seller or importer pursuant to this section be immediately suspended if the ,secretary determines that there is a pattern of importation of such specific drug or by such specific seller or importer that involves counterfeit drugs1 drugs that have been recalled or withdrawn1 or drugs in violation of any requirement of this section1 until an investigation is completed and the ,secretary determines that importation of such drug or by such seller or importer does not endanger the public health4 7#b7 ,temporary suspension ,the ,secretary may require that importation of a specific qualifying prescription drug or importation by a specific certified foreign seller or importer pursuant to this section be temporarily suspended if1 with respect to such drug1 seller1 or importer1 there is a violation of any requirement of this section or if the ,secretary determines that importation of such drug or by such seller or importer might endanger the public health4 ,such temporary suspension shall apply until the ,secretary completes an investigation and determines that importation of such drug or by such seller or importer does not endanger the public health4 7k7 ,supply chain security 7#a7 ,purchase from registered facilities and certified foreign sellers 7,a7 ,in general ,except as provided in subparagraph 7,b71 certified foreign sellers who sell qualifying prescription drugs for importation into the ,united ,states pursuant to this section may purchase such drugs only from manufacturers or entities registered under section #eaj or other certified foreign sellers4 7,b7 ,exception ,certified foreign sellers who sell qualifying prescription drugs for importation into the ,united ,states pursuant to this section may purchase such drugs from foreign sellers in ,canada or another permitted country1 even if such foreign seller is not a manufacturer registered under section #eaj or a certified foreign seller1 if the ,secretary enters into a memorandum of understanding or cooperative agreement with ,canada1 or such other permitted country1 to ensure compliance1 to the extent appropriate and feasible1 with subchapter ,h of chapter ,v4 ,the ,secretary shall seek to enter into such a memorandum of understanding or cooperative agreement with ,canada and each country from which importation is permitted under subsection 7e74 7#b7 ,importation tracing ,certified foreign sellers shall provide importers with the unique facility identifier associated with the manufacturer registered under section #eaj of the qualifying prescription drug and the information under paragraph 7#be71 paragraph 7#bf7 7other than subparagraph 7,c771 and subparagraphs 7,d71 7,f71 and 7,g7 of paragraph 7#bg7 of section #eha4 ,certified foreign sellers shall provide such information to individuals purchasing such drugs1 upon request4 7l7 ,r,e,ms ,in the case of an importer that imports a qualifying prescription drug1 where the drug with the same active ingredient or ingredients 7or that is biosimilar to an approved biological product71 route of administration1 and strength that is approved under chapter ,v or section #cea of the ,public ,health ,service ,act is subject to elements to assure safe use under section #eje-a1 such importer shall be subject to such elements to assure safe use1 as applicable and appropriate4 7m7 ,construction ,nothing in this section limits the authority of the ,secretary relating to the importation of prescription drugs1 other than with respect to section #hja7;d77#a7 as provided in this section4 4 7b7 ,penalties with respect to online pharmacies ,section #cjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 is amended by adding at the end the following3 7h7 ,in the case of a person operating an internet website1 whether in the ,united ,states or in another country1 that violates section #cja7;aa7 by-- 7#a7 selling1 by means of the internet1 with the intent to defraud or mislead or with reckless disregard for safety of the public1 an adulterated or counterfeit drug to an individual in the ,united ,states2 or 7#b7 dispenses1 by means of the internet1 a drug to an individual in the ,united ,states who the person knows or has reasonable cause to believe1 does not possess a valid prescription for that drug1 such person shall be imprisoned for not more than #aj years or fined not more than #bej1jjj4 4 7c7 ,no preemption ,nothing in this section1 including the amendments made by this section1 shall be construed to preempt1 alter1 displace1 abridge1 or supplant any remedy available under any ,state or ,federal law1 including common law1 that provides a remedy for civil relief4 7d7 ,reports 7#a7 ,,hhs ,not later than #a year after the date on which final regulations are promulgated to carry out section #hjd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd71 as amended by subsection 7a71 and every #b years thereafter1 the ,secretary of ,health and ,human ,services1 after consultation with appropriate ,federal agencies1 shall submit to ,congress and make public a report on the importation of drugs into the ,united ,states4 7#b7 ,,gao report ,not later than #ah months after the first report is submitted under paragraph 7#a71 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report containing an analysis of the implementation of the amendments made by this section1 including a review of drug safety and cost-savings and expenses1 including cost-savings to consumers in the ,united ,states and trans-shipment and importation tracing processes1 resulting from such implementation4 #bjd4 ,requiring drug manufacturers to provide drug rebates for drugs dispensed to low-income individuals 7a7 ,in general ,section #ahfj;,d-#b of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7 is amended-- 7#a7 in subsection 7e77#a71 in the matter preceding subparagraph 7,a71 by inserting and subsection 7f7 after this subsection2 and 7#b7 by adding at the end the following new subsection3 7f7 ,prescription drug rebate agreement for rebate eligible individuals 7#a7 ,requirement 7,a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbj1 in this part1 the term covered part ,d drug does not include any drug or biological product that is manufactured by a manufacturer that has not entered into and have in effect a rebate agreement described in paragraph 7#b74 7,b7 #bjbj plan year requirement ,any drug or biological product manufactured by a manufacturer that declines to enter into a rebate agreement described in paragraph 7#b7 for the period beginning on ,january #a1 #bjbj1 and ending on ,december #ca1 #bjbj1 shall not be included as a covered part ,d drug for the subsequent plan year4 7#b7 ,rebate agreement ,a rebate agreement under this subsection shall require the manufacturer to provide to the ,secretary a rebate for each rebate period 7as defined in paragraph 7#f77;,b77 ending after ,december #ca1 #bjai1 in the amount specified in paragraph 7#c7 for any covered part ,d drug of the manufacturer dispensed after ,december #ca1 #bjai1 to any rebate eligible individual 7as defined in paragraph 7#f77;,a77 for which payment was made by a ,,pdp sponsor or ,,ma organization under this part for such period1 including payments passed through the low-income and reinsurance subsidies under sections #ahfj;,d-#ad and #ahfj;,d-#ae7;b71 respectively4 ,such rebate shall be paid by the manufacturer to the ,secretary not later than #cj days after the date of receipt of the information described in section #ahfj;,d-#ab7;b77#h71 including as such section is applied under section #aheg7;f77#c71 or #cj days after the receipt of information under subparagraph 7,d7 of paragraph 7#c71 as determined by the ,secretary4 ,insofar as not inconsistent with this subsection1 the ,secretary shall establish terms and conditions of such agreement relating to compliance1 penalties1 and program evaluations1 investigations1 and audits that are similar to the terms and conditions for rebate agreements under paragraphs 7#c7 and 7#d7 of section #aibg7;b74 7#c7 ,rebate for rebate eligible ,medicare drug plan enrollees 7,a7 ,in general ,the amount of the rebate specified under this paragraph for a manufacturer for a rebate period1 with respect to each dosage form and strength of any covered part ,d drug provided by such manufacturer and dispensed to a rebate eligible individual1 shall be equal to the product of-- 7i7 the total number of units of such dosage form and strength of the drug so provided and dispensed for which payment was made by a ,,pdp sponsor or an ,,ma organization under this part for the rebate period1 including payments passed through the low-income and reinsurance subsidies under sections #ahfj;,d-#ad and #ahfj;,d-#ae7;b71 respectively2 and 7ii7 the amount 7if any7 by which-- 7,i7 the ,medicaid rebate amount 7as defined in subparagraph 7,b77 for such form1 strength1 and period2 exceeds 7,,ii7 the average ,medicare drug program rebate eligible rebate amount 7as defined in subparagraph 7,c77 for such form1 strength1 and period4 7,b7 ,medicaid rebate amount ,for purposes of this paragraph1 the term ,medicaid rebate amount means1 with respect to each dosage form and strength of a covered part ,d drug provided by the manufacturer for a rebate period-- 7i7 in the case of a single source drug or an innovator multiple source drug1 the amount specified in paragraph 7#a77;,a77ii77,,ii7 or 7#b77;,c7 of section #aibg7;c7 plus the amount1 if any1 specified in subparagraph 7,a77ii7 of paragraph 7#b7 of such section1 for such form1 strength1 and period2 or 7ii7 in the case of any other covered outpatient drug1 the amount specified in paragraph 7#c77;,a77i7 of such section for such form1 strength1 and period4 7,c7 ,average ,medicare drug program rebate eligible rebate amount ,for purposes of this subsection1 the term average ,medicare drug program rebate eligible rebate amount means1 with respect to each dosage form and strength of a covered part ,d drug provided by a manufacturer for a rebate period1 the sum1 for all ,,pdp sponsors under part ,d and ,,ma organizations administering an ,,ma-,,pd plan under part ,c1 of-- 7i7 the product1 for each such sponsor or organization1 of-- 7,i7 the sum of all rebates1 discounts1 or other price concessions 7not taking into account any rebate provided under paragraph 7#b7 or any discounts under the program under section #ahfj;,d-#ad;,a7 for such dosage form and strength of the drug dispensed1 calculated on a per-unit basis1 but only to the extent that any such rebate1 discount1 or other price concession applies equally to drugs dispensed to rebate eligible ,medicare drug plan enrollees and drugs dispensed to ,,pdp and ,,ma-,,pd enrollees who are not rebate eligible individuals2 and 7,,ii7 the number of the units of such dosage and strength of the drug dispensed during the rebate period to rebate eligible individuals enrolled in the prescription drug plans administered by the ,,pdp sponsor or the ,,ma-,,pd plans administered by the ,,ma organization2 divided by 7ii7 the total number of units of such dosage and strength of the drug dispensed during the rebate period to rebate eligible individuals enrolled in all prescription drug plans administered by ,,pdp sponsors and all ,,ma-,,pd plans administered by ,,ma organizations4 7,d7 ,use of estimates ,the ,secretary may establish a methodology for estimating the average ,medicare drug program rebate eligible rebate amounts for each rebate period based on bid and utilization information under this part and may use these estimates as the basis for determining the rebates under this section4 ,if the ,secretary elects to estimate the average ,medicare drug program rebate eligible rebate amounts1 the ,secretary shall establish a reconciliation process for adjusting manufacturer rebate payments not later than #c months after the date that manufacturers receive the information collected under section #ahfj;,d-#ab7;b77#h77;,b74 7#d7 ,length of agreement ,the provisions of paragraph 7#d7 of section #aibg7;b7 7other than clauses 7iv7 and 7v7 of subparagraph 7,b77 shall apply to rebate agreements under this subsection in the same manner as such paragraph applies to a rebate agreement under such section4 7#e7 ,other terms and conditions ,the ,secretary shall establish other terms and conditions of the rebate agreement under this subsection1 including terms and conditions related to compliance1 that are consistent with this subsection4 7#f7 ,definitions ,in this subsection and section #ahfj;,d-#ab7;b77#h73 7,a7 ,rebate eligible individual ,the term rebate eligible individual means-- 7i7 a subsidy eligible individual 7as defined in section #ahfj;,d-#ad7;a77#c77;,a772 7ii7 a ,medicaid beneficiary treated as a subsidy eligible individual under clause 7v7 of section #ahfj;,d-#ad7;a77#c77;,b72 and 7iii7 any part ,d eligible individual not described in clause 7i7 or 7ii7 who is determined for purposes of the ,state plan under title ,,xix to be eligible for medical assistance under clause 7i71 7iii71 or 7iv7 of section #aijb7;a77#aj77;,e74 7,b7 ,rebate period ,the term rebate period has the meaning given such term in section #aibg7k77#h74 4 7b7 ,reporting requirement for the determination and payment of rebates by manufacturers related to rebate for rebate eligible ,medicare drug plan enrollees 7#a7 ,requirements for ,,pdp sponsors ,section #ahfj;,d-#ab7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is amended by adding at the end the following new paragraph3 7#h7 ,reporting requirement for the determination and payment of rebates by manufacturers related to rebate for rebate eligible ,medicare drug plan enrollees 7,a7 ,in general ,for purposes of the rebate under section #ahfj;,d-#b7;f7 for contract years beginning on or after ,january #a1 #bjbj1 each contract entered into with a ,,pdp sponsor under this part with respect to a prescription drug plan shall require that the sponsor comply with subparagraphs 7,b7 and 7,c74 7,b7 ,report form and contents ,not later than a date specified by the ,secretary1 a ,,pdp sponsor of a prescription drug plan under this part shall report to each manufacturer-- 7i7 information 7by ,national ,drug ,code number7 on the total number of units of each dosage1 form1 and strength of each drug of such manufacturer dispensed to rebate eligible ,medicare drug plan enrollees under any prescription drug plan operated by the ,,pdp sponsor during the rebate period2 7ii7 information on the price discounts1 price concessions1 and rebates for such drugs for such form1 strength1 and period2 7iii7 information on the extent to which such price discounts1 price concessions1 and rebates apply equally to rebate eligible ,medicare drug plan enrollees and ,,pdp enrollees who are not rebate eligible ,medicare drug plan enrollees2 and 7iv7 any additional information that the ,secretary determines is necessary to enable the ,secretary to calculate the average ,medicare drug program rebate eligible rebate amount 7as defined in paragraph 7#c77;,c7 of such section71 and to determine the amount of the rebate required under this section1 for such form1 strength1 and period4 ,such report shall be in a form consistent with a standard reporting format established by the ,secretary4 7,c7 ,submission to ,secretary ,each ,,pdp sponsor shall promptly transmit a copy of the information reported under subparagraph 7,b7 to the ,secretary for the purpose of audit oversight and evaluation4 7,d7 ,confidentiality of information ,the provisions of subparagraph 7,d7 of section #aibg7;b77#c71 relating to confidentiality of information1 shall apply to information reported by ,,pdp sponsors under this paragraph in the same manner that such provisions apply to information disclosed by manufacturers or wholesalers under such section1 except-- 7i7 that any reference to this section in clause 7i7 of such subparagraph shall be treated as being a reference to this section2 7ii7 the reference to the ,director of the ,congressional ,budget ,office in clause 7iii7 of such subparagraph shall be treated as including a reference to the ,medicare ,payment ,advisory ,commission2 and 7iii7 clause 7iv7 of such subparagraph shall not apply4 7,e7 ,oversight ,information reported under this paragraph may be used by the ,inspector ,general of the ,department of ,health and ,human ,services for the statutorily authorized purposes of audit1 investigation1 and evaluations4 7,f7 ,penalties for failure to provide timely information and provision of false information ,in the case of a ,,pdp sponsor-- 7i7 that fails to provide information required under subparagraph 7,b7 on a timely basis1 the sponsor is subject to a civil money penalty in the amount of #aj1jjj for each day in which such information has not been provided2 or 7ii7 that knowingly 7as defined in section #aabh;,a7i77 provides false information under such subparagraph1 the sponsor is subject to a civil money penalty in an amount not to exceed #ajj1jjj for each item of false information4 ,such civil money penalties are in addition to other penalties as may be prescribed by law4 ,the provisions of section #aabh;,a 7other than subsections 7a7 and 7b77 shall apply to a civil money penalty under this subparagraph in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a7a74 4 7#b7 ,application to ,,ma organizations ,section #aheg7;f77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;f77#c77 is amended by adding at the end the following3 7,e7 ,reporting requirement related to rebate for rebate eligible ,medicare drug plan enrollees ,section #ahfj;,d-#ab7;b77#h74 4 7c7 ,deposit of rebates into ,medicare ,prescription ,drug ,account ,section #ahfj;,d-#af7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaf7;c77 is amended by adding at the end the following new paragraph3 7#f7 ,rebate for rebate eligible ,medicare drug plan enrollees ,amounts paid under a rebate agreement under section #ahfj;,d-#b7;f7 shall be deposited into the ,account4 4 7d7 ,exclusion from determination of best price and average manufacturer price under ,medicaid 7#a7 ,exclusion from best price determination ,section #aibg7;c77#a77;,c77ii77,i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#a77;,c77ii77,i77 is amended by inserting and amounts paid under a rebate agreement under section #ahfj;,d-#b7;f7 after this section4 7#b7 ,exclusion from average manufacturer price determination ,section #aibg7k77#a77;,b77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#a77;,b77i77 is amended-- 7,a7 in subclause 7,,iv71 by striking and after the semicolon2 7,b7 in subclause 7,v71 by striking the period at the end and inserting 2 and2 and 7,c7 by adding at the end the following3 7,,vi7 amounts paid under a rebate agreement under section #ahfj;,d-#b7;f74 4 #bje4 ,cap on prescription drug cost-sharing 7a7 ,qualified health plans ,section #acjb7;c7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjbb7;c77 is amended-- 7#a7 in paragraph 7#c77;,a77i71 by inserting 1 including cost-sharing with respect to prescription drugs covered by the plan after charges2 and 7#b7 by adding at the end the following3 7#e7 ,prescription drug cost-sharing 7,a7 #bjbj ,for plan years beginning in #bjbj1 the cost-sharing incurred under a health plan with respect to prescription drugs covered by the plan shall not exceed #bej per month for each enrolled individual1 or #ejj for each family4 7,b7 #bjba and later 7i7 ,in general ,in the case of any plan year beginning in a calendar year after #bjbj1 the limitation under this paragraph shall be equal to the applicable dollar amount under subparagraph 7,a7 for plan years beginning in #bjbj1 increased by an amount equal to the product of that amount and the medical care component of the consumer price index for all urban consumers 7as published by the ,bureau of ,labor ,statistics7 for that year4 7ii7 ,adjustment to amount ,if the amount of any increase under clause 7i7 is not a multiple of #e1 such increase shall be rounded to the next lowest multiple of #e4 4 7b7 ,group health plans ,section #bgjg7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#f7;b77 is amended-- 7#a7 by striking annual2 and 7#b7 by striking paragraph 7#a7 of section #acjb7;c7 and inserting paragraphs 7#a7 and 7#e7 of section #acjb7;c7 of the ,patient ,protection and ,affordable ,care ,act4 7c7 ,effective date ,the amendments made by subsections 7a7 and 7b7 shall take effect with respect to plans beginning after ,december #ca1 #bjai4 #bjf4 ,modification of trade negotiating objectives relating to intellectual property rights to ensure access to biological products ,section #ajb7;b77#e77;,c7 of the ,bipartisan ,congressional ,trade ,priorities and ,accountability ,act of #bjae 7#ai ,u4,s4,c4 #dbja7;b77#e77;,c77 is amended by striking the end period and inserting the following3 1 including by ensuring that trade agreements do not require a party to provide biological product exclusivity of more than #g years4 4 ,,iii ,innovation #cja4 ,innovation incentive fund for new and more effective treatments of bacterial infections ,part ,b of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhd et seq47 is amended by adding at the end the following3 #dji,k4 ,innovation incentive fund for new and more effective treatments of bacterial infections 7a7 ,establishment of fund ,there is hereby established in the ,treasury of the ,united ,states a revolving fund to be known as the ,antibiotics ,innovation ,incentive ,fund1 which shall consist of funds transferred under subsection 7b74 7b7 ,amounts credited to the fund ,there are hereby authorized to be appropriated1 and appropriated1 to the ,antibiotics ,innovation ,incentive ,fund1 for fiscal year #bjbj1 out of any monies in the ,treasury not otherwise appropriated1 #b1jjj1jjj1jjj4 ,such funds shall remain available until expended4 7c7 ,awards 7#a7 ,in general ,during the #aj-year period following the date of enactment of the ,affordable ,medications ,act1 the ,director of the ,,nih1 in accordance with the criteria under subsection 7d7 and the goals under subsection 7e71 shall award-- 7,a7 up to #c market entry awards for qualifying products that provide added benefit for patients over existing therapies in the treatment of serious and life-threatening bacterial infections demonstrating in superiority trials2 and 7,b7 award open source dividend prizes for contributions that significantly advance the field of antibiotic research with openly sourced materials1 technology1 data1 and knowledge4 7#b7 ,award amount requirements ,no more than #e percent of the amount available in the ,antibiotics ,innovation ,incentive shall be dedicated to open source dividend prizes4 7d7 ,criteria and structure of prizes 7#a7 ,establishment of criteria ,not later than #abj days after the date of enactment of the ,affordable ,medications ,act1 the ,director of ,,nih shall establish criteria for the selection of recipients and eligibility of persons for market entry rewards and open source dividend prizes under this section and criteria for determining the amounts of such prizes1 through notice and comment rulemaking4 7#b7 ,considerations in establishing criteria for qualifying products ,in establishing the criteria for selection of recipients and amounts of market entry rewards and open source dividend prizes under paragraph 7#a71 the ,director of ,,nih1 in consultation with other agencies as appropriate1 shall consider the following3 7,a7 ,the number of patients in the ,united ,states and in other countries who would benefit from the qualifying product that treats a serious or life-threatening bacterial infection1 and the number of patients in the ,united ,states and in other countries projected to benefit during the upcoming #aj-year period4 7,b7 ,whether the qualifying product treats1 or has the potential to treat1 a serious or life-threatening bacterial infection for which no other treatment is currently available or for which there is a high threat of resistance to existing treatments4 7,c7 ,the incremental and additional therapeutic benefit to human in the ,united ,states and other countries of the qualifying product as compared to other treatments available to treat the bacterial infection1 evaluating the incremental therapeutic benefit in comparison to treatments that were not recently developed4 7,d7 ,the transmissibility of the bacterial infection the qualifying product would treat1 and barriers to prevention of that infection4 7,e7 ,the extent to which knowledge1 data1 materials1 and technology that are openly sourced have contributed to the successful development of new treatments that provide an added benefit to patients1 such as decreasing mortality or irreversible morbidity on patient-centered outcomes1 significantly advancing the field of antibiotic research1 or improving processes for manufacturing products used for the treatment4 7,f7 ,other criteria that the ,director of ,,nih determines to be relevant and useful in ensuring that the prizes provide appropriate incentives4 7#c7 ,criteria for open source dividend prizes ,an open source dividend prize under this section shall reward persons that openly shared on a royalty-free1 not-for-profit and non-discriminatory basis1 materials1 technology1 data1 and knowledge that contribute in a significant way to the successful development of a qualifying product or significantly advanced the field of antibiotic research4 7e7 ,goals ,with respect to each year for which the ,director of ,,nih awards market entry rewards and open source dividend prizes under subsection 7c71 the ,director of ,,nih shall establish a framework of goals that a qualifying product or contribution that significantly advances the field of antibiotic research is required to show promise to help meet in order for a person to be eligible to receive a market entry reward or open source dividend prize with respect to such product or such contribution4 ,such goals may include-- 7#a7 reduced hospital admissions or readmissions2 7#b7 use of diagnostics prior to prescribing of drugs2 and 7#c7 use of innovative programs for antibiotic stewardship4 7f7 ,condition on receipt of market entry reward 7#a7 ,in general ,each market entry reward for a qualifying product offered under this section shall be conditioned on the following3 7,a7 ,the recipient shall agree to offer the qualifying product at a reasonable price as described in paragraph 7#c74 7,b7 ,subject to applicable patient privacy protections1 the recipient shall agree to publicly disclose all pre-clinical and clinical trial data with respect to the qualifying product4 7,c7 ,the recipient shall agree to submit to the ,director of ,,nih1 for review and approval by such director1 in collaboration with the ,commissioner of ,food and ,drugs and the ,director of the ,centers for ,disease ,control and ,prevention1 all marketing1 sales1 and other promotional and educational activities associated with the qualifying product1 to ensure that such activities align with1 and advance the goals of1 resource conserving stewardship1 protecting the utility of antibiotics1 and encouraging and ensuring the correct use of antibiotics4 7,d7 ,the recipient shall irrevocably waive-- 7i7 all periods of exclusivity available to the product under chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea of this ,act2 and 7ii7 all applicable patent rights under title #ce1 ,united ,states ,code4 7,e7 ,any other conditions the ,director of ,,nih determines appropriate4 7#b7 ,applicability ,all conditions described in paragraph 7#a7 shall apply to subsequent owners1 licensees1 producers1 and manufacturers1 and assignees of the product or any chemical component of the qualifying product for which the market entry reward was awarded4 7#c7 ,reasonable price 7,a7 ,in general ,a recipient may satisfy the requirement to offer a qualifying product or contribution at a reasonable price for purposes of paragraph 7#a77;,a7 by-- 7i7 7,i7 providing open licensing of all necessary rights to patents1 manufacturing processes1 rights in data1 and other intellectual property rights needed to make and sell the product to manufacturers of the generic version of such product2 or 7,,ii7 selling such product at a price that is no more than twice the price of antibiotic drugs approved under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act with similar manufacturing costs2 and 7ii7 selling such product at a price that is not higher than the median price charged1 at the time of such sale1 in the applicable #g countries1 as determined under in subparagraph 7,b74 7,b7 ,criteria ,for purposes of subparagraph 7,a77ii71 the ,director of ,,nih shall identify1 on an annual basis1 the countries that have a per capita income that is not less than half the per capita income of the ,united ,states1 select the #g of such countries that have the largest gross domestic product1 and determine the median price charged for each qualifying product for which an award has been granted under subsection 7c74 7g7 ,enforcement ,if the market entry reward recipient1 or subsequent owner1 licensee1 or assignee of the qualifying product1 does not fulfill the conditions described subsection 7f77#a71 the ,secretary1 in collaboration with the ,attorney ,general1 shall take all necessary action to clawback the market entry reward4 7h7 ,transparency ,with respect to each market entry reward or open source dividend prize awarded under this section1 the ,director of ,,nih shall make public-- 7#a7 the methodology used and criteria analyzed in determining the market entry reward or open source dividend prize recipient2 and 7#b7 a complete analysis of the recipient's fulfillment of award conditions under subsection 7e77#a74 7i7 ,qualifying product ,for purposes of this section1 the term qualifying product means a drug 7as defined in section #bja7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act7 subject to section #ejc7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7j7 ,study 7#a7 ,in general ,the ,director of ,,nih shall seek to enter into an agreement with the ,national ,academies of ,sciences1 ,engineering1 and ,medicine to conduct a study to examine-- 7,a7 the use of innovation inducement reward funds and push financing mechanisms as ways to stimulate investments in biomedical research and development that de-links costs from product prices2 7,b7 models of different possible means of de-linking research and development costs from drug prices1 including the progressive replacement of the monopoly on new products with a combination of expanded research subsidies and new incentives from innovation inducement funds to stimulate the development of drugs1 including drugs to treat bacterial infections1 rare diseases1 ,,hiv_/,,aids1 and cancer2 7,c7 the size of market entry rewards1 open source dividends and other innovation inducement prizes that would be necessary to achieve innovation objectives and the relative cost effectiveness of incentives delinked from the prices of products and services in stimulating innovation1 compared to time-limited monopolies2 and 7,d7 methods of progressively implementing policies that delink research and development funding from prices of products and services1 including to the progressive reduction in the effective term of exclusive rights1 accompanied by a progressive introduction and expansion of market entry rewards4 7#b7 ,authorization of appropriations ,for the purpose of carrying out this subsection1 there are authorized to be appropriated1 and there are appropriated1 #c1jjj1jjj for fiscal year #bjbj4 ,such funds shall remain available until expended4 4 #cjb4 ,public funding for clinical trials 7a7 ,in general ,part ,e of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhg et seq47 is amended by adding at the end the following3 #f ,center for ,clinical ,research #dhe;,e4 ,center for ,clinical ,research 7a7 ,in general ,there is established within the ,national ,institutes of ,health the ,center for ,clinical ,research1 for the purpose of conducting clinical trials on drugs1 as described in subsection 7b71 with the intention of obtaining approval of such drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea of this ,act4 ,the ,director of ,,nih shall appoint a ,director of the ,center for ,clinical ,research referred to in this section as the ,director7 not later than #ij days after the date of enactment of the ,affordable ,medications ,act4 7b7 ,clinical trials 7#a7 ,in general ,each year1 beginning not later than #a year after the date of enactment of the ,affordable ,medications ,act1 the ,director shall select at least #b molecules1 compounds1 drugs1 or biological products and conduct clinical trials on such molecules1 compounds1 drugs1 or biological products1 or enter into contracts with other entities to conduct such clinical trials4 7#b7 ,selection of drugs 7,a7 ,criteria ,the ,director shall establish criteria1 which shall be made public1 for acquiring the patent rights for1 and selecting1 drugs under paragraph 7#a7 to ensure that the drugs selected for clinical trials through the ,center-- 7i7 have the potential to address an existing or emerging need1 including drugs that can be repurposed to treat a new condition in the case of a national emergency2 and 7ii7 are not solely drugs that private sector researchers with access to all available information on such drugs chose not to develop4 7,b7 ,process ,the ,director shall secure all patent rights to each drug selected under paragraph 7#a71 as applicable1 and perform the clinical trials at ,,nih or subcontract with another entity to conduct the clinical trials4 7c7 ,treatment of approved drugs ,if a drug for which clinical trials have been conducted by the ,center for ,clinical ,research is approved by the ,food and ,drug ,administration under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea of this ,act1 the ,director shall-- 7#a7 execute non-exclusive licenses to allow drug manufacturers to manufacture and sell the drug2 or 7#b7 in collaboration with other ,federal agencies as appropriate1 enter into purchasing contracts4 7d7 ,public information 7#a7 ,research data and findings ,subject to applicable patient privacy protections1 the ,secretary shall-- 7,a7 7i7 submit all completed studies 7and terminated studies1 if terminated for safety or ethical reasons7 for publication in a peer-reviewed publication within #ahj days of completion or termination2 and 7ii7 if a study submitted as described in clause 7i7 is not selected for publication1 publicly disclose all de-identified primary clinical data not later than #ahj days after the ,secretary's final decision not to pursue further submissions for publication2 and 7,b7 publicly disclose all de-identified primary clinical data upon publication of a study as described in subparagraph 7,a77i74 7#b7 ,financial information ,the ,director shall make public all costs to the ,federal ,government associated with carrying out clinical trials by the ,center for ,clinical ,research and with subcontract agreements under this section1 in a manner that identifies the cost associated with each trial4 7e7 ,definition ,in this section1 the term drug has the meaning given such term in section #bja7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7f7 ,appropriations ,for the purpose of carrying out this section1 in addition to any other funds available for such purpose1 there are authorized to be appropriated1 and there are appropriated1 #a1jjj1jjj1jjj for each of fiscal years #bjbj through #bjcj1 to remain available until expended4 4 7b7 ,clerical amendment ,section #dja7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bha7;b77 is amended-- 7#a7 by redesignating paragraph 7#be7 as paragraph 7#bf72 and 7#b7 by inserting after paragraph 7#bd7 the following3 7#be7 ,the ,center for ,clinical ,research4 4 #cjc4 ,rewarding innovative drug development 7a7 ,drug exclusivity 7#a7 ,new chemical entity exclusivity 7,a7 ,in general ,section #eje7;j77#e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77 is amended-- 7i7 in subparagraph 7,b7-- 7,i7 in clause 7i71 by inserting except that such approval may not be made effective before the date that is #e years after the date on which the drug to which the application refers was approved under subsection 7c7 before the period2 and 7,,ii7 in clause 7ii71 by inserting except that such approval may not be made effective before the date that is #e years after the date on which the drug to which the application refers was approved under subsection 7c7 before the period2 and 7ii7 in subparagraph 7,f77ii7-- 7,i7 by striking expiration of five years and inserting expiration of #c years2 7,,ii7 by striking 1 except that such an application may be submitted under this subsection after the expiration of four years from the date of the approval of the subsection 7b7 application if it contains a certification of patent invalidity or noninfringement described in subclause 7,,iv7 of paragraph 7#b77;,a77vii72 and 7,,iii7 by striking seven and one-half years and inserting #f and one-half years4 7,b7 ,conforming amendments ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended-- 7i7 in subsection 7v77#b77;,a77i77,,ii7 of section #eje1 by inserting the #c-year exclusivity period referred to before under clause 7ii7 of subsection 7j77#e77;,f72 7ii7 in subsections 7b77#a77;,a77i77,i7 and 7c77#a77;,a77i77,i7 of section #eje;,a-- 7,i7 by striking five years each place such term appears and inserting #c years2 7,,ii7 by striking seven and one-half years each place such term appears and inserting #f and one-half years2 and 7,,iii7 by striking eight years each place such term appears and inserting #g years2 and 7iii7 in section #eje;,e1 by striking the #d- and #e-year periods described in subsections 7c77#c77;,e77ii7 and 7j77#e77;,f77ii7 of section #eje1 the #c-year periods described in clauses 7iii7 and 7iv7 of subsection 7c77#c77;,e7 and clauses 7iii7 and 7iv7 of subsection 7j77#e77;,f7 and inserting the #d- and #e-year periods described in subsection 7c77#c77;,e77ii7 of section #eje1 the #c-year periods described in clauses 7iii7 and 7iv7 of subsection 7c77#c77;,e7 and clauses 7ii71 7iii71 and 7iv7 of subsection 7j77#e77;,f74 7#b7 ,new clinical investigation exclusivity ,section #eje7;c77#c77;,e77iv7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77#c77;,e77iv77 is amended by inserting 1 and the supplement shows a significant clinical benefit over existing therapies manufactured by the applicant in the #e-year period preceding the submission of the application1 before the ,secretary4 7#c7 ,biological product exclusivity 7,a7 ,in general ,section #cea7k77#g77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#g77;,a77 is amended by striking #ab years and inserting #g years4 7,b7 ,conforming amendments ,paragraphs 7#b77;,a7 and 7#c77;,a7 of section #cea7m7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7m77 is amended by striking #ab years each place it appears and inserting #g years4 7b7 ,applicability ,the amendments made by subsection 7a7 apply only with respect to a drug or biological product for which the listed drug 7as described in section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g777 or reference product 7as such term is used in section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb77 is approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under section #cea7;a7 of the ,public ,health ,service ,act1 as applicable1 on or after the date of enactment of this ,act4 7c7 ,,gao study ,not later than #a year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a study and submit to ,congress a report that includes-- 7#a7 7,a7 the number of requests for designation as a drug for a rare disease or condition under section #ebf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb7 the ,food and ,drug ,administration receives each year in the previous #aj-year period2 7,b7 the number of such requests granted1 denied1 and pending2 7,c7 the names of all drugs receiving such designation during such period1 including the date of approval and indication for which market exclusivity was granted2 and 7,d7 any drugs for which such designation has been revoked or amended during such period2 7#b7 for each drug so designated as a drug for a rare disease or condition in the previous #aj-year period1 the total annual expenditures for such drugs under the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 and the ,medicaid program under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq471 the number of ,medicare and ,medicaid beneficiaries who used each such drug each year during such time period1 and any changes in price per unit during such time period2 and 7#c7 for a sample of drugs 7selected by the ,comptroller ,general7 so designated in the previous #aj-year period1 to the extent feasible-- 7,a7 gross revenues of the manufacturers with respect to each such drug1 and manufacturer spending for marketing and patient assistance programs2 7,b7 the average price per drug and how those prices changed over time for the selected drugs based on industry drug pricing benchmarks2 and 7,c7 the indications that were the basis of such designation and other approved indications for the drugs1 and the indications for which each drug has most commonly been used1 including non-approved indications for which the drug may be recommended by external organizations such as physician or patient organizations4 #cjd4 ,improving program integrity 7a7 ,in general ,subchapter ,e of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb et seq47 is amended by adding at the end the following3 #efi;,e4 ,conditions on award of drug exclusivity 7a7 ,termination of exclusivity ,notwithstanding any other provision of this ,act1 any period of exclusivity described in subsection 7b7 granted to a person or assigned to a person on or after the date of enactment of this section with respect to a drug shall be terminated if the person to which such exclusivity was granted or any person to which such exclusivity is assigned commits a violation described in subsection 7c77#a7 with respect to such drug4 7b7 ,exclusivities affected ,the periods of exclusivity described in this subsection are those periods of exclusivity granted under any of the following sections3 7#a7 ,clause 7ii71 7iii71 or 7iv7 of section #eje7;c77#c77;,e74 7#b7 ,clause 7iv7 of section #eje7;j77#e77;,b74 7#c7 ,clause 7ii71 7iii71 or 7iv7 of section #eje7;j77#e77;,f74 7#d7 ,section #eje;,a4 7#e7 ,section #eje;,e4 7#f7 ,section #ebg4 7#g7 ,section #cea7k77#g7 of the ,public ,health ,service ,act4 7#h7 ,any other provision of this ,act that provides for market exclusivity 7or extension of market exclusivity7 with respect to a drug4 7c7 ,violations 7#a7 ,in general ,a violation described in this subsection is a violation of a law described in paragraph 7#b71 enforced by a ,federal or ,state governmental entity that results in-- 7,a7 a criminal conviction of a person described in subsection 7a72 7,b7 a civil judgment against a person described in subsection 7a72 or 7,c7 a settlement agreement in which a person described in subsection 7a7 admits to fault4 7#b7 ,laws described ,the laws described in this paragraph are the following3 7,a7 ,the provisions of this ,act that prohibit-- 7i7 the adulteration or misbranding of a drug2 7ii7 the making of false statements to the ,secretary or committing fraud2 or 7iii7 the illegal marketing of a drug4 7,b7 ,section #cgbi of title #ca1 ,united ,states ,code4 7,c7 ,section #bhf or #bhg of title #ah1 ,united ,states ,code4 7,d7 ,the ,medicare and ,medicaid ,patient ,protection and ,program ,act of #aihg 7commonly known as the ,antikickback ,statute74 7,e7 ,section #aibg of the ,social ,security ,act4 7,f7 ,a ,state law against fraud comparable to a law described in subparagraphs 7,a7 through 7,e74 7d7 ,date of exclusivity termination ,the date on which the exclusivity shall be terminated as described in subsection 7a7 is the date on which1 as applicable-- 7#a7 a final judgment is entered relating to a violation described in subparagraph 7,a7 or 7,b7 of subsection 7c77#a72 or 7#b7 7,a7 a settlement agreement described in subsection 7c77#a77;,c7 is approved by a court order that is or becomes final and nonappealable2 or 7,b7 if there is no court order approving a settlement agreement described in subsection 7c77#a77;,c71 a court order dismissing the applicable case1 issued after the settlement agreement1 is or becomes final and nonappealable4 7e7 ,reporting of information 7#a7 ,in general ,a person described in subsection 7a7 that commits a violation described in subsection 7c77#a7 shall report such violation to the ,secretary no later than #cj days after the date that-- 7,a7 a final judgment is entered relating to a violation described in subparagraph 7,a7 or 7,b7 of subsection 7c77#a72 or 7,b7 7i7 a settlement agreement described in subsection 7c77#a77;,c7 is approved by a court order that is or becomes final and nonappealable2 or 7ii7 if there is no court order approving a settlement agreement described in subsection 7c77#a77;,c71 a court order dismissing the applicable case1 issued after the settlement agreement1 is or becomes final and nonappealable4 7#b7 ,civil penalty ,a person who fails to report a violation as required under paragraph 7#a7 shall be subject to a civil penalty in the amount of #bjj1jjj for each day the failure to report continues1 beginning with the day after the date on which such report is due as described in paragraph 7#a74 4 7b7 ,,ftc ,there are authorized to be appropriated to the ,federal ,trade ,commission such sums as may be necessary for the purpose of carrying out activities related to addressing criminal activity and anticompetitive practices by pharmaceutical companies4 ,,iv ,choice and ,competition #dja4 ,unlawful compensation for delay 7a7 ,in general ,the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #dd et seq47 is amended by inserting after section #bf 7#ae ,u4,s4,c4 #eg;c-#b7 the following3 #bg4 ,preserving access to affordable generics and biosimilars 7a7 ,in general 7#a7 ,enforcement proceeding ,the ,commission may initiate a proceeding to enforce the provisions of this section against the parties to any agreement resolving or settling1 on a final or interim basis1 a patent infringement claim1 in connection with the sale of a drug product or biological product4 7#b7 ,presumption and violation 7,a7 ,in general ,subject to subparagraph 7,b71 in such a proceeding1 an agreement shall be presumed to have anticompetitive effects and shall be a violation of this section if-- 7i7 an ,,anda filer or a biosimilar biological product application filer receives anything of value1 including an exclusive license2 and 7ii7 the ,,anda filer or biosimilar biological product application filer agrees to limit or forego research1 development1 manufacturing1 marketing1 or sales of the ,,anda product or biosimilar biological product1 as applicable1 for any period of time4 7,b7 ,exception ,subparagraph 7,a7 shall not apply if the parties to such agreement demonstrate by clear and convincing evidence that-- 7i7 the value described in subparagraph 7,a77i7 is compensation solely for other goods or services that the ,,anda filer or biosimilar biological product application filer has promised to provide2 or 7ii7 the procompetitive benefits of the agreement outweigh the anticompetitive effects of the agreement4 7b7 ,limitations ,in determining whether the settling parties have met their burden under subsection 7a77#b77;,b71 the fact finder shall not presume-- 7#a7 that entry would not have occurred until the expiration of the relevant patent or statutory exclusivity2 or 7#b7 that the agreement's provision for entry of the ,,anda product or biosimilar biological product prior to the expiration of the relevant patent or statutory exclusivity means that the agreement is procompetitive4 7c7 ,exclusions ,nothing in this section shall prohibit a resolution or settlement of a patent infringement claim in which the consideration granted by the ,,nda holder or biological product license holder to the ,,anda filer or biosimilar biological product application filer1 respectively1 as part of the resolution or settlement includes only one or more of the following3 7#a7 ,the right to market the ,,anda product or biosimilar biological product in the ,united ,states prior to the expiration of-- 7,a7 any patent that is the basis for the patent infringement claim2 or 7,b7 any patent right or other statutory exclusivity that would prevent the marketing of such ,,anda product or biosimilar biological product4 7#b7 ,a payment for reasonable litigation expenses not to exceed #g1ejj1jjj4 7#c7 ,a covenant not to sue on any claim that the ,,anda product or biosimilar biological product infringes a ,united ,states patent4 7d7 ,enforcement 7#a7 ,enforcement ,a violation of this section shall be treated as a violation of section #e4 7#b7 ,judicial review 7,a7 ,in general ,any party that is subject to a final order of the ,commission1 issued in an administrative adjudicative proceeding under the authority of subsection 7a77#a71 may1 within #cj days of the issuance of such order1 petition for review of such order in-- 7i7 the ,united ,states ,court of ,appeals for the ,district of ,columbia ,circuit2 7ii7 the ,united ,states ,court of ,appeals for the circuit in which the ultimate parent entity1 as defined in section #hja4a7;a77#c7 of title #af1 ,code of ,federal ,regulations1 or any successor thereto1 of the ,,nda holder or biological product license holder is incorporated as of the date that the ,,nda or biological product license application1 as applicable1 is filed with the ,commissioner of ,food and ,drugs2 or 7iii7 the ,united ,states ,court of ,appeals for the circuit in which the ultimate parent entity of the ,,anda filer or biosimilar biological product application filer is incorporated as of the date that the ,,anda or biosimilar biological product application is filed with the ,commissioner of ,food and ,drugs4 7,b7 ,treatment of findings ,in a proceeding for judicial review of a final order of the ,commission1 the findings of the ,commission as to the facts1 if supported by evidence1 shall be conclusive4 7e7 ,antitrust laws ,nothing in this section shall modify1 impair1 limit1 or supersede the applicability of the antitrust laws as defined in subsection 7a7 of the first section of the ,clayton ,act 7#ae ,u4,s4,c4 #ab7;a771 and of section #e of this ,act to the extent that section #e applies to unfair methods of competition4 ,nothing in this section shall modify1 impair1 limit1 or supersede the right of an ,,anda filer or biosimilar biological product application filer to assert claims or counterclaims against any person1 under the antitrust laws or other laws relating to unfair competition4 7f7 ,penalties 7#a7 ,forfeiture ,each party that violates or assists in the violation of this section shall forfeit and pay to the ,united ,states a civil penalty sufficient to deter violations of this section1 but in no event greater than #c times the value received by the party that is reasonably attributable to the violation of this section4 ,if no such value has been received by the ,,nda holder or biological product license holder1 the penalty to the ,,nda holder or biological product license holder shall be sufficient to deter violations1 but in no event greater than #c times the value given to the ,,anda filer or biosimilar biological product application filer reasonably attributable to the violation of this section4 ,such penalty shall accrue to the ,united ,states and may be recovered in a civil action brought by the ,commission1 in its own name by any of its attorneys designated by it for such purpose1 in a district court of the ,united ,states against any party that violates this section4 ,in such actions1 the ,united ,states district courts are empowered to grant mandatory injunctions and such other and further equitable relief as they deem appropriate4 7#b7 ,cease and desist 7,a7 ,in general ,if the ,commission has issued a cease and desist order with respect to a party in an administrative adjudicative proceeding under the authority of subsection 7a77#a71 an action brought pursuant to paragraph 7#a7 may be commenced against such party at any time before the expiration of #a year after such order becomes final pursuant to section #e7;g74 7,b7 ,exception ,in an action under subparagraph 7,a71 the findings of the ,commission as to the material facts in the administrative adjudicative proceeding with respect to the violation of this section by a party shall be conclusive unless-- 7i7 the terms of such cease and desist order expressly provide that the ,commission's findings shall not be conclusive2 or 7ii7 the order became final by reason of section #e7;g77#a71 in which case such finding shall be conclusive if supported by evidence4 7#c7 ,civil penalty ,in determining the amount of the civil penalty described in this section1 the court shall take into account-- 7,a7 the nature1 circumstances1 extent1 and gravity of the violation2 7,b7 with respect to the violator1 the degree of culpability1 any history of violations1 the ability to pay1 any effect on the ability to continue doing business1 profits earned by the ,,nda holder or biological product license holder1 compensation received by the ,,anda filer or biosimilar biological product application filer1 and the amount of commerce affected2 and 7,c7 other matters that justice requires4 7#d7 ,remedies in addition ,remedies provided in this subsection are in addition to1 and not in lieu of1 any other remedy provided by ,federal law4 ,nothing in this paragraph shall be construed to affect any authority of the ,commission under any other provision of law4 7g7 ,definitions ,in this section3 7#a7 ,agreement ,the term agreement means anything that would constitute an agreement under section #a of the ,sherman ,act 7#ae ,u4,s4,c4 #a7 or section #e of this ,act4 7#b7 ,agreement resolving or settling a patent infringement claim ,the term agreement resolving or settling a patent infringement claim includes any agreement that is entered into within #cj days of the resolution or the settlement of the claim1 or any other agreement that is contingent upon1 provides a contingent condition for1 or is otherwise related to the resolution or settlement of the claim4 7#c7 ,,anda ,the term ,,anda means an abbreviated new drug application filed under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 or a new drug application filed under section #eje7;b77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#b774 7#d7 ,,anda filer ,the term ,,anda filer means a party that owns or controls an ,,anda filed with the ,food and ,drug ,administration or has the exclusive rights under such ,,anda to distribute the ,,anda product4 7#e7 ,,anda product ,the term ,,anda product means the product to be manufactured under the ,,anda that is the subject of the patent infringement claim4 7#f7 ,biological product ,the term biological product has the meaning given such term in section #cea7;i77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i77#a774 7#g7 ,biological product license application ,the term biological product license application means an application under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a774 7#h7 ,biological product license holder ,the term biological product license holder means-- 7,a7 the holder of an approved biological product license application for a biological product2 7,b7 a person owning or controlling enforcement of any patents that claim the biological product that is the subject of such approved application2 or 7,c7 the predecessors1 subsidiaries1 divisions1 groups1 and affiliates controlled by1 controlling1 or under common control with any of the entities described in subparagraphs 7,a7 and 7,b7 7such control to be presumed by direct or indirect share ownership of #ej percent or greater71 as well as the licensees1 licensors1 successors1 and assigns of each of the entities4 7#i7 ,biosimilar biological product ,the term biosimilar biological product means the product to be manufactured under the biosimilar biological product application that is the subject of the patent infringement claim4 7#aj7 ,biosimilar biological product application ,the term biosimilar biological product application means an application under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 for licensure of a biological product as biosimilar to1 or interchangeable with1 a reference product4 7#aa7 ,biosimilar biological product application filer ,the term biosimilar biological product application filer means a party that owns or controls a biosimilar biological product application filed with the ,food and ,drug ,administration or has the exclusive rights under such application to distribute the biosimilar biological product4 7#ab7 ,drug product ,the term drug product has the meaning given such term in section #cad4c7;b7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulation74 7#ac7 ,,nda ,the term ,,nda means a new drug application filed under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b774 7#ad7 ,,nda holder ,the term ,,nda holder means-- 7,a7 the holder of an approved ,,nda application for a drug product2 7,b7 a person owning or controlling enforcement of the patent listed in the ,approved ,drug ,products ,with ,therapeutic ,equivalence ,evaluations 7commonly known as the ,,fda ,orange ,book7 in connection with the ,,nda2 or 7,c7 the predecessors1 subsidiaries1 divisions1 groups1 and affiliates controlled by1 controlling1 or under common control with any of the entities described in subparagraphs 7,a7 and 7,b7 7such control to be presumed by direct or indirect share ownership of #ej percent or greater71 as well as the licensees1 licensors1 successors1 and assigns of each of the entities4 7#ae7 ,party ,the term party means any person1 partnership1 corporation1 or other legal entity4 7#af7 ,patent infringement ,the term patent infringement means infringement of any patent or of any filed patent application1 extension1 reissue1 renewal1 division1 continuation1 continuation in part1 reexamination1 patent term restoration1 patents of addition1 and extensions thereof4 7#ag7 ,patent infringement claim ,the term patent infringement claim means any allegation made to an ,,anda filer or biosimilar biological product application filer1 whether or not included in a complaint filed with a court of law1 that its ,,anda or ,,anda product1 or biological product license application or biological product1 may infringe any patent held by1 or exclusively licensed to1 the ,,nda holder or biological product license holder of the drug product or biological product1 as applicable4 7#ah7 ,statutory exclusivity ,the term statutory exclusivity means those prohibitions on the approval of drug applications under clauses 7ii7 through 7iv7 of section #eje7;c77#c77;,e7 7#e- and #c-year data exclusivity71 section #ebg 7orphan drug exclusivity71 or section #eje;,a 7pediatric exclusivity7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77#c77;,e71 #cfj;cc1 #cee;a71 or on the licensing of biological product applications under section #cea7k77#g7 7#ab-year exclusivity7 or paragraph 7#b7 or 7#c7 of section #cea7m7 7pediatric exclusivity7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 or under section #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7orphan drug exclusivity74 4 7b7 ,effective date ,section #bg of the ,federal ,trade ,commission ,act1 as added by this section1 shall apply to all agreements described in section #bg7;a77#a7 of that ,act entered into after ,june #ag1 #bjac4 ,section #bg7;f7 of the ,federal ,trade ,commission ,act1 as added by this section1 shall apply to agreements entered into on or after the date of enactment of this ,act4 #djb4 #ahj-;day exclusivity period amendments regarding first applicant status 7a7 ,amendments to ,federal ,food1 ,drug1 and ,cosmetic ,act 7#a7 ,in general ,section #eje7;j77#e77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b77 is amended-- 7,a7 in clause 7iv77,,ii7-- 7i7 by striking item 7bb72 and 7ii7 by redesignating items 7cc7 and 7dd7 as items 7bb7 and 7cc71 respectively2 and 7,b7 by adding at the end the following3 7v7 ,first applicant defined ,as used in this subsection1 the term first applicant means an applicant-- 7,i7 7aa7 that1 on the first day on which a substantially complete application containing a certification described in paragraph 7#b77;,a77vii77,,iv7 is submitted for approval of a drug1 submits a substantially complete application that contains and lawfully maintains a certification described in paragraph 7#b77;,a77vii77,,iv7 for the drug2 and 7bb7 that has not entered into a disqualifying agreement described under clause 7vii77,,ii72 or 7,,ii7 7aa7 for the drug that is not described in subclause 7,i7 and that1 with respect to the applicant and drug1 each requirement described in clause 7vi7 is satisfied2 and 7bb7 that has not entered into a disqualifying agreement described under clause 7vii77,,ii74 7vi7 ,requirement ,the requirements described in this clause are the following3 7,i7 ,the applicant described in clause 7v77,,ii7 submitted and lawfully maintains a certification described in paragraph 7#b77;,a77vii77,,iv7 or a statement described in paragraph 7#b77;,a77viii7 for each unexpired patent for which a first applicant described in clause 7v77,i7 had submitted a certification described in paragraph 7#b77;,a77vii77,,iv7 on the first day on which a substantially complete application containing such a certification was submitted4 7,,ii7 ,with regard to each such unexpired patent for which the applicant described in clause 7v77,,ii7 submitted a certification described in paragraph 7#b77;,a77vii77,,iv71 no action for patent infringement was brought against such applicant within the #de-;day period specified in paragraph 7#e77;,b77iii72 or if an action was brought within such time period1 such an action was withdrawn or dismissed by a court 7including a district court7 without a decision that the patent was valid and infringed2 or if an action was brought within such time period and was not withdrawn or so dismissed1 such applicant has obtained the decision of a court 7including a district court7 that the patent is invalid or not infringed 7including any substantive determination that there is no cause of action for patent infringement or invalidity1 and including a settlement order or consent decree signed and entered by the court stating that the patent is invalid or not infringed74 7,,iii7 ,if an applicant described in clause 7v77,i7 has begun commercial marketing of such drug1 the applicant described in clause 7v77,,ii7 does not begin commercial marketing of such drug until the date that is #cj days after the date on which the applicant described in clause 7v77,i7 began such commercial marketing4 4 7#b7 ,conforming amendment ,section #eje7;j77#e77;,d77i77,,iv7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,d77i77,,iv77 is amended by striking ,the first applicant and inserting ,the first applicant1 as defined in subparagraph 7,b77v77,i714 7b7 ,applicability ,the amendments made by subsection 7a7 shall apply only with respect to an application filed under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 to which the amendments made by section #aajb7;a7 of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc 7,public ,law #ajh-agc7 apply4 #djc4 #ahj-;day exclusivity period amendments regarding agreements to defer commercial marketing 7a7 ,amendments to ,federal ,food1 ,drug1 and ,cosmetic ,act 7#a7 ,limitations on agreements to defer commercial marketing date ,section #eje7;j77#e77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b771 as amended by section #djb1 is further amended by adding at the end the following3 7vii7 ,agreement by first applicant to defer commercial marketing2 limitation on acceleration of deferred commercial marketing date 7,i7 ,agreement to defer approval or commercial marketing date ,an agreement described in this subclause is an agreement between a first applicant and the holder of the application for the listed drug or an owner of one or more of the patents as to which any applicant submitted a certification qualifying such applicant for the #ahj-;day exclusivity period whereby that applicant agrees1 directly or indirectly1 7aa7 not to seek an approval of its application that is made effective on the earliest possible date under this subparagraph1 subparagraph 7,f7 of this paragraph1 section #eje;,a1 or section #ebg1 7bb7 not to begin the commercial marketing of its drug on the earliest possible date after receiving an approval of its application that is made effective under this subparagraph1 subparagraph 7,f7 of this paragraph1 section #eje;,a1 or section #ebg1 or 7cc7 to both items 7aa7 and 7bb74 7,,ii7 ,agreement that disqualifies applicant from first applicant status ,an agreement described in this subclause is an agreement between an applicant and the holder of the application for the listed drug or an owner of one or more of the patents as to which any applicant submitted a certification qualifying such applicant for the #ahj-;day exclusivity period whereby that applicant agrees1 directly or indirectly1 not to seek an approval of its application or not to begin the commercial marketing of its drug until a date that is after the expiration of the #ahj-;day exclusivity period awarded to another applicant with respect to such drug 7without regard to whether such #ahj-;day exclusivity period is awarded before or after the date of the agreement74 7viii7 ,limitation on acceleration ,if an agreement described in clause 7vii77,i7 includes more than #a possible date when an applicant may seek an approval of its application or begin the commercial marketing of its drug-- 7,i7 the applicant may seek an approval of its application or begin such commercial marketing on the date that is the earlier of-- 7aa7 the latest date set forth in the agreement on which that applicant can receive an approval that is made effective under this subparagraph1 subparagraph 7,f7 of this paragraph1 section #eje;,a1 or section #ebg1 or begin the commercial marketing of such drug1 without regard to any other provision of such agreement pursuant to which the commercial marketing could begin on an earlier date2 or 7bb7 #ahj days after another first applicant begins commercial marketing of such drug2 and 7,,ii7 the latest date set forth in the agreement on which that applicant can receive an approval that is made effective under this subparagraph1 subparagraph 7,f7 of this paragraph1 section #eje;,a1 or section #ebg1 or begin the commercial marketing of such drug1 without regard to any other provision of such agreement pursuant to which commercial marketing could begin on an earlier date1 shall be the date used to determine whether an applicant is disqualified from first applicant status pursuant to clause 7vii77,,ii74 4 7#b7 ,notification of ,,fda ,section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 is amended by adding at the end the following3 7#ad7 7,a7 ,the holder of an abbreviated application under this subsection shall submit to the ,secretary a notification that includes-- 7i7 7,i7 the text of any agreement entered into by such holder described under paragraph 7#e77;,b77vii77,i72 or 7,,ii7 if such an agreement has not been reduced to text1 a written detailed description of such agreement that is sufficient to disclose all the terms and conditions of the agreement2 and 7ii7 the text1 or a written detailed description in the event of an agreement that has not been reduced to text1 of any other agreements that are contingent upon1 provide a contingent condition for1 or are otherwise related to an agreement described in clause 7i74 7,b7 ,the notification described under subparagraph 7,a7 shall be submitted not later than #aj business days after execution of the agreement described in subparagraph 7,a77i74 ,such notification is in addition to any notification required under section #aaab of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc4 7,c7 ,any information or documentary material filed with the ,secretary pursuant to this paragraph shall be exempt from disclosure under section #eeb of title #e1 ,united ,states ,code1 and no such information or documentary material may be made public1 except as may be relevant to any administrative or judicial action or proceeding4 ,nothing in this paragraph is intended to prevent disclosure to either body of the ,congress or to any duly authorized committee or subcommittee of the ,congress4 4 7#c7 ,prohibited acts ,section #cja7;e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7;e77 is amended by striking #eje 7i7 or 7k7 and inserting #eje 7i71 7j77#aa71 or 7k74 7b7 ,infringement of patent ,section #bga7;e7 of title #ce1 ,united ,states ,code1 is amended by adding at the end the following3 7#g7 ,the exclusive remedy under this section for an infringement of a patent for which the ,secretary of ,health and ,human ,services has published information pursuant to subsection 7b77#a7 or 7c77#b7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act shall be an action brought under this subsection within the #de-;day period described in subsection 7j77#e77;,b77iii7 or 7c77#c77;,c7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 4 7c7 ,applicability 7#a7 ,limitations on acceleration of deferred commercial marketing date ,the amendment made by subsection 7a77#a7 shall apply only with respect to-- 7,a7 an application filed under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 to which the amendments made by section #aajb7;a7 of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc 7,public ,law #ajh-agc7 apply2 and 7,b7 an agreement described under section #eje7;j77#e77;,b77vii77,i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7a77#a77 executed after the date of enactment of this ,act4 7#b7 ,notification of ,,fda ,the amendments made by paragraphs 7#b7 and 7#c7 of subsection 7a7 shall apply only with respect to an agreement described under section #eje7;j77#e77;,b77vii77,i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7a77#a77 executed after the date of enactment of this ,act4 #djd4 ,increasing drug competition and preventing drug shortages ,section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is amended by adding at the end the following3 7,d7 7i7 ,the ,commissioner shall-- 7,i7 not later than #i months after the date of enactment of the ,affordable ,medications ,act1 publish a complete1 up-to-date list on the internet website of the ,food and ,drug ,administration of all drugs1 including authorized generics1 together with1 with respect to the drug1 as applicable-- 7aa7 the drug trade name2 7bb7 the established name2 7cc7 each active pharmaceutical ingredient facility 7as defined in section #gdd;,b7a77#d77;a77ii772 7dd7 each generic drug facility2 7ee7 each contract manufacturing organization facility 7as defined in section #gdd;,a7#e772 7ff7 the date any authorized generic drug entered the market2 7gg7 the marketing status2 and 7hh7 any other information the ,secretary may require to mitigate or prevent drug shortages2 7,,ii7 designate each drug on the list that is a sole-source generic drug2 7,,iii7 designate each drug on the list that is an essential medicine1 as identified by the ,world ,health ,organization1 or another entity designated by the ,secretary that meets evidence-based standards as required by the ,secretary2 and 7,,iv7 maintain a confidential list of the identity and address of each facility described in subclause 7,i71 and publicly report on the website only the city and ,state or country of each such facility4 7ii7 ,the ,commissioner may choose not to make information collected under clause 7i7 publicly available if the ,secretary determines that disclosure of such information would adversely affect the public health 7such as by increasing the possibility of hoarding or other disruption of the availability of drug products to patients74 7iii7 ,the ,commissioner shall notify relevant ,federal agencies1 including the ,centers for ,medicare ,medicaid ,services and the ,federal ,trade ,commission1 when the ,commissioner first publishes the information under clause 7i7 that the information has been published and will be updated regularly4 7iv7 ,in this subparagraph1 the term sole-source means1 with respect to a drug1 there is not more than one approved drug on the list of drugs under subparagraph 7,a71 not including drugs on the discontinued section of such list4 4 #dje4 ,disallowance of deduction for advertising for prescription drugs 7a7 ,in general ,part ,,ix of subchapter ,b of chapter #a of subtitle ,a of the ,internal ,revenue ,code of #aihf 7relating to items not deductible7 is amended by adding at the end the following new section3 #bhj;,i4 ,disallowance of deduction for direct-to-consumer advertising of prescription drugs 7a7 ,in general ,no deduction shall be allowed under this chapter for expenses relating to direct-to-consumer advertising of prescription drugs for any taxable year4 7b7 ,direct-to-,consumer advertising ,for purposes of this section1 the term direct-to-consumer advertising means any dissemination1 by or on behalf of a sponsor of a prescription drug product 7as such term is defined in section #gce7c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act71 of an advertisement which-- 7#a7 is in regard to such prescription drug product1 and 7#b7 primarily targeted to the general public1 including through-- 7,a7 publication in journals1 magazines1 other periodicals1 and newspapers1 7,b7 broadcasting through media such as radio1 television1 telephone communication systems1 direct mail1 and billboards1 7,c7 dissemination on the internet 7including social media71 and 7,d7 manufacturer patient assistance programs1 as defined in section #cii,v-#g of the ,public ,health ,service ,act4 4 7b7 ,conforming amendment ,the table of sections for such part ,,ix of the ,internal ,revenue ,code of #aihf is amended by adding after the item relating to section #bhj;,h the following new item3 ,sec4 #bhj;,i4 ,disallowance of deduction for direct-to-consumer advertising of prescription drugs4 4 7c7 ,effective date ,the amendments made by subsections 7a7 and 7b7 shall apply to amounts paid or incurred after the date of the enactment of this ,act1 in taxable years ending after such date4 7d7 ,oversight of prescription drugs 7#a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary71 acting through the ,commissioner of ,food and ,drugs and in coordination with other ,federal agencies1 shall conduct oversight of the risks and benefits of drugs that are on the market and how such risks are presented in drug advertisements for the purpose of correcting false or misleading information published in direct-to-consumer advertisements and to disseminate corrective information to health care providers and the general public regarding the risks and benefits of a drug on an quarterly basis4 7#b7 ,prereview of television advertisements ,the ,secretary1 acting through the ,commissioner of ,food and ,drugs and in consultation with relevant stakeholders1 shall issue new1 or update current1 guidance issued under section #ejc;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;c74 ,in carrying out this paragraph1 the ,secretary shall focus on drugs that present the greatest risk to consumers1 drugs that represent the greatest proportion of total spending in ,federal programs1 drugs with high unit price increases over the preceding year1 drugs with high launch prices1 or any other priority drugs identified by the ,secretary4 7#c7 ,funding ,there is authorized to be appropriated to the ,secretary an amount equal to the increase in revenue resulting from the enactment of section #bhj;,i of the ,internal ,revenue ,code of #aihf1 as added by subsection 7a74 #djf4 ,drug manufacturer duty to disclose drug prices to practitioners 7a7 ,duty ,to disclose ,whenever a drug manufacturer1 including any representative of the manufacturer1 communicates with a health care practitioner about a drug manufactured by the drug manufacturer1 including through promotional1 educational1 or marketing communications1 meetings or paid events1 and the provision of goods1 gifts1 and samples1 the drug manufacturer shall disclose to the practitioner the wholesale acquisition cost 7as defined in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b777 for a #cj-;day supply of the drug1 which may include a brief qualitative explanation of reduced cost availability for certain consumers4 7b7 ,enforcement by ,federal ,trade ,commission 7#a7 ,unfair or deceptive acts or practices ,a violation of subsection 7a7 by a person with respect to whom the ,commission is empowered under section #e7;a77#b7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#b77 shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under section #ah7;a77#a77;,b7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #eg;a7a77#a77;,b774 7#b7 ,powers of ,federal ,trade ,commission 7,a7 ,in general ,the ,federal ,trade ,commission shall enforce this section in the same manner1 by the same means1 and with the same jurisdiction1 powers1 and duties as though all applicable terms and provisions of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et seq47 were incorporated into and made a part of this ,act4 7,b7 ,privileges and immunities ,any person who violates this section shall be subject to the penalties and entitled to the privileges and immunities provided in the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et seq474 7c7 ,rulemaking ,the ,federal ,trade ,commission shall promulgate in accordance with section #eec of title #e1 ,united ,states ,code1 such rules as may be necessary to carry out this section4 7d7 ,savings provision ,nothing in this section shall be construed to limit1 impair1 or supersede the operation of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et seq47 or any other provision of ,federal law4 #djg4 ,excluding authorized generic drugs from calculation of average manufacturer price under the ,medicaid drug rebate program 7a7 ,in general ,subparagraph 7,c7 of section #aibg7k77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#a77 is amended-- 7#a7 in the subparagraph heading1 by striking ,inclusion and inserting ,exclusion2 7#b7 by striking a new drug application and inserting the manufacturer's new drug application2 and 7#c7 by striking inclusive and inserting exclusive4 7b7 ,effective date ,the amendments made by this section shall take effect on the first day of the first fiscal quarter that begins after the date of enactment of this ,act4