,,ii #aafth ,,congress #b;d ,session ,s4 #caff ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,january #h1 #bjbj,mr4 ,booker 7for himself1 ,mr4 ,sanders1 and ,ms4 ,harris7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to lower the cost of drugs for all ,americans4 #a4 ,short title ,this ,act may be cited as the ,prescription ,drug ,affordability and ,access ,act4 #b4 ,establishment of the ,bureau of ,prescription ,drug ,affordability and ,access 7a7 ,establishment 7#a7 ,in general ,there is established within the ,department of ,health and ,human ,services an independent bureau1 known as the ,bureau of ,prescription ,drug ,affordability and ,access 7in this ,act referred to as the ,bureau7 to carry out the duties described in this section4 ,the purposes of the ,bureau are to-- 7,a7 attain lower prescription drug costs for patients2 7,b7 decrease government expenditures on prescription drugs2 and 7,c7 ensure access to prescription drugs4 7#b7 ,executive agency ,the ,bureau shall be considered an ,executive agency1 as defined in section #aje of title #e1 ,united ,states ,code4 7#c7 ,director 7,a7 ,appointment ,the ,bureau shall be headed by a ,director 7in this ,act referred to as the ,director7 who shall be appointed by the ,president1 by and with the advice and consent of the ,senate4 7,b7 ,qualification ,the ,president shall nominate the ,director from among individuals who are citizens of the ,united ,states4 7,c7 ,term ,the ,director shall serve for a term of #e years4 ,the term of the first ,director to be appointed shall begin on the date that is #ahj days after the date of enactment of this ,act4 7#d7 ,consultation 7,a7 ,in general ,in carrying out the duties under this section1 the ,bureau shall regularly consult with relevant stakeholders1 including patients1 representatives of relevant ,federal agencies1 and medical and health care finance experts4 ,the ,bureau shall have regular public meetings to solicit input from relevant stakeholders4 7,b7 ,patient engagement 7i7 ,in general ,the ,director shall ensure that patients or organizations representing patients have opportunities to meaningfully engage with the ,bureau as it conducts its work1 including while the ,bureau makes appropriate price determinations under section #c7;d74 ,such opportunities may include holding regular panels1 forums1 and other meetings for patient engagement4 7ii7 ,petition ,the ,director shall establish a process by which patients can petition the entity and raise concerns about the price of their prescription drugs4 7,c7 ,consumer ,advisory ,council 7i7 ,establishment ,the ,director shall establish a ,consumer ,advisory ,council to advise and consult with the ,bureau as it conducts its work4 7ii7 ,membership ,the ,council established under this subparagraph shall be composed of not fewer than #f members appointed by the ,director4 ,in appointing members to the ,council1 the ,director shall ensure that at least half of the members of the ,council are patients or organizations representing patients1 particularly those who have been significantly impacted by high priced medications4 ,the ,director shall also seek to appoint members to the ,council who are experts in relevant areas1 including medicine and health care finance4 7iii7 ,meetings ,the ,consumer ,advisory ,council shall meet from time to time at the call of the ,director but shall meet at least twice a year4 7#e7 ,employment condition 7,a7 ,in general ,an individual who has a conflict of interest shall not be appointed to be a member of1 or employed by1 the ,bureau1 including the ,consumer ,advisory ,council established under paragraph 7#d77;,c74 7,b7 ,disclosure ,individuals under consideration for employment by1 or appointment to1 the ,bureau1 including the ,consumer ,advisory ,council1 must disclose any potential conflict of interest1 including the type1 nature1 and magnitude of the interests involved4 7b7 ,duties ,the ,bureau shall carry out the following duties3 7#a7 ,carry out the provisions of section #c4 7#b7 ,submit the annual reports under subsection 7c74 7#c7 ,any other duty that the ,director determines appropriate4 7c7 ,annual reporting 7#a7 ,in general ,not later than ,january #a1 #bjba1 and annually thereafter1 the ,director shall submit to ,congress a report on the activities of the ,bureau4 7#b7 ,contents ,each report under paragraph 7#a7 shall contain the following3 7,a7 ,a description of the activities of the ,bureau1 including-- 7i7 the total estimated savings achieved by the ,bureau since the most recent report2 7ii7 the disaggregated savings achieved since the most recent report1 including by each therapeutic class of prescription drugs2 7iii7 a summary of the information submitted by prescription drug manufacturers as required under section #c2 and 7iv7 the impact of the ,bureau's work on patient affordability and access to prescription drugs4 7,b7 ,recommendations for such legislation and administrative action as the ,bureau determines appropriate4 7,c7 ,a copy of each report submitted by drug manufacturers as required under section #c4 7,d7 ,other items that the ,bureau determines appropriate4 7d7 ,funding ,there are appropriated1 from amounts in the ,treasury not otherwise appropriated1 #ej1jjj1jjj for fiscal year #bjbj and each subsequent fiscal year to carry out the activities of the ,bureau4 ,amounts appropriated under the preceding sentence shall remain available until expended4 #c4 ,prescription drug consumer price protections 7a7 ,review of prices 7#a7 ,in general ,the ,bureau shall conduct reviews of the prices of prescription drugs to ensure that the wholesale acquisition cost of each such drug is appropriate4 7#b7 ,information on prescription drugs approved as of enactment 7,a7 ,manufacturer submission ,with respect to any prescription drug that1 as of the date of enactment of this ,act1 has in effect an application approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 each manufacturer1 not later than #ahj days after such date of enactment1 shall provide to the ,bureau the following information3 7i7 ,the name of the prescription drug4 7ii7 ,a description of the prescription drug and its approved indications4 7iii7 ,the number of individuals in the ,united ,states and globally for which such prescription drug is clinically indicated4 7iv7 ,a list of patents that claim the prescription drug1 a use of the prescription drug1 a form of the prescription drug1 a method of use of the prescription drug1 or a method of manufacture of the prescription drug4 7v7 ,a list of government-granted exclusivities that prohibit the submission or approval of a prescription drug and the date that each such government-granted exclusivity was granted4 7vi7 ,the date on which the prescription drug was approved under such section #eje or such section #cea of the ,public ,health ,service ,act4 7vii7 ,the total expenditures of the manufacturer on-- 7,i7 domestic and foreign research and development1 including an itemized description of-- 7aa7 clinical research1 including the cost of each clinical trial associated with the prescription drug1 reported separately for each clinical trial2 7bb7 the development of alternative dosage forms and strengths for the prescription drug molecule or combinations1 including the molecule2 7cc7 other prescription drug development activities1 such as nonclinical laboratory studies and record and report maintenance2 7dd7 pursuing new or expanded indications for such prescription drug through supplemental applications under such section #eje or such section #cea2 7ee7 carrying out postmarket requirements related to such prescription drug1 including under subsection 7o7 of such section #eje or such section #cea2 7ff7 carrying out risk evaluation and mitigation strategies in accordance with section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7 or such section #cea2 and 7gg7 marketing research2 7,,ii7 the acquisition of prescription drug components and packaging1 in total and per unit sold1 broken out by source and cost and identifying specific costs that reflect internal transfers within the manufacturer's company2 7,,iii7 other acquisitions relating to the prescription drug1 including for the purchase of patents and licensing or acquisition of any corporate entity owning any rights to the drug during or after development of the prescription drug2 7,,iv7 the cost of manufacturing the prescription drug2 7,v7 marketing1 advertising1 and educating for the promotion of a prescription drug1 including a breakdown of amounts aimed at consumers1 prescribers1 managed care organizations1 and others1 irrespective of whether a prescription drug is mentioned in marketing1 advertising1 or educating2 and 7,,vi7 patient assistance and co-pay programs that the manufacturer sponsors or contributes to4 7viii7 ,the gross revenue1 net revenue1 gross profit1 and net profit of the manufacturer with respect to such prescription drug4 7ix7 ,the total number of units of such prescription drug that were sold in interstate commerce4 7x7 ,pricing information with respect to the sale of such prescription drug1 including-- 7,i7 the current wholesale acquisition cost2 7,,ii7 the introductory wholesale acquisition cost2 7,,iii7 the net average price realized by pharmacy benefit managers for such prescription drug 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 7,,iv7 the list price of such prescription drug charged to purchasers in each applicable prescription drug reference country2 7,v7 the net price of such prescription drug1 after accounting for discounts1 rebates1 or other financial considerations1 charged to purchasers in each applicable prescription drug reference country2 7,,vi7 a description of all price changes of the prescription drug since the introductory wholesale acquisition cost2 and 7,,vii7 the average net price of such prescription drug for each year since first being sold in the ,united ,states4 7xi7 ,any ,federal benefits and amounts and periods of impact for each such benefit received by the manufacturer with respect to the prescription drug1 including tax credits1 ,federal grants1 patent applications that benefitted from such grants1 patent extensions1 exclusivity periods1 and waivers of fees4 7xii7 ,the percentage of research and development expenditures described in this section that were derived from ,federal funds4 7xiii7 ,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 officers4 7xiv7 ,other information as the ,director may require4 7,b7 ,bureau review priorities ,in reviewing submissions under subparagraph 7,a71 the ,bureau shall prioritize prescription drugs that meet any of the following criteria3 7i7 ,in the top #ejth percentile of net spending on prescription drugs under any ,federal program1 including the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 or the ,medicaid program under title ,,xix of such ,act 7#db ,u4,s4,c4 #acif et seq474 7ii7 ,in the top #ejth percentile of utilization under any ,federal program1 including such ,medicare program or such ,medicaid program4 7iii7 ,experienced an increase in the wholesale acquisition cost of #be percent or more over the preceding #c years4 7iv7 ,other qualifications1 as determined by the ,director4 7#c7 ,information on prescription drugs approved after enactment ,with respect to any prescription drug approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 after the date of enactment of this ,act1 each manufacturer1 not later than #de days prior to introducing such prescription drug into interstate commerce in the ,united ,states1 shall provide to the ,bureau the following information3 7,a7 ,the information described in the following provisions of paragraph 7#b77;,a73 7i7 ,clauses 7i7 through 7vi74 7ii7 ,subclauses 7,i7 through 7,,iv7 of clause 7vii74 7iii7 ,clauses 7xi7 through 7xiv74 7,b7 ,pricing information with respect to the sale of such prescription drug1 including-- 7i7 the planned introductory wholesale acquisition cost2 7ii7 the list price of such prescription drug charged or planned to be charged to purchasers in each applicable prescription drug reference country2 and 7iii7 the net price of such prescription drug1 after accounting for discounts1 rebates1 or other financial considerations1 charged or planned to be charged to purchasers in each applicable prescription drug reference country1 as defined in this ,act4 7,c7 ,the estimated annual profit and revenue that will be generated by the prescription drug1 both domestically and globally4 7,d7 ,other information as the ,director may require4 7b7 ,review of certain price increases 7#a7 ,in general ,the ,bureau shall conduct a review of the price of a prescription drug for which a submission is required under paragraph 7#b74 7#b7 ,notification of intention to increase price ,if a manufacturer intends to increase the wholesale acquisition cost of a prescription drug by more than the percentage by which the ,consumer ,price ,index for ,all ,urban ,consumers for that year exceeds such index for the preceding calendar year1 such manufacturer1 not later than #fj days before the price increase takes effect1 shall submit to the ,bureau the following information3 7,a7 ,the information described in subsection 7a77#b77;,a74 7,b7 ,the planned increase in the wholesale acquisition cost and the planned date the increase will go into effect4 7,c7 ,a justification of the planned increase in wholesale acquisition cost4 7,d7 ,any other information as the ,secretary may require4 7c7 ,revenue benchmark review 7#a7 ,in general ,the ,bureau shall conduct a review of a prescription drug when revenue for such prescription drug surpasses the revenue benchmark in order to ensure that the wholesale acquisition cost of the prescription drug remains appropriate4 7#b7 ,required submission ,not later than #fj days before the manufacturer of a prescription drug anticipates the global revenue for such drug will surpass the revenue benchmark1 the manufacturer shall submit to the ,bureau the information outlined in subsection 7a77#b77;,a74 7#c7 ,revenue benchmark 7,a7 ,in general ,subject to subparagraph 7,b71 for purposes of this subsection1 the revenue benchmark is #e1jjj1jjj1jjj in global revenue4 7,b7 ,update ,the ,bureau may update the amount of the global benchmark over time4 7d7 ,general authority ,to review 7#a7 ,in general ,the ,bureau may at any time review the wholesale acquisition cost of a prescription drug to determine if such price is appropriate1 including in response to a patient petition as described in section 7#b77;a77#c77;,b77ii74 7#b7 ,procedure ,the ,bureau shall notify the manufacturer of a prescription drug it wishes to review pursuant to the authority under this subsection1 and1 within #de days of receiving such a notification1 the manufacturer shall submit to the ,bureau information the ,bureau determines necessary for its review4 7e7 ,appropriate price determinations 7#a7 ,considerations ,in determining whether the wholesale acquisition cost or proposed wholesale acquisition cost of a prescription drug is appropriate1 the ,bureau shall consider the following3 7,a7 ,the size of the affected patient population4 7,b7 ,the therapeutic benefits of the prescription drug to patients4 7,c7 ,the impact of the price on access to the prescription drug1 including for patients who are uninsured1 and the associated financial burden on patients that utilize such prescription drug4 7,d7 ,the total annual ,federal ,government expenditures on the prescription drug and the budgetary impact of ,federal health programs providing coverage of the prescription drug4 7,e7 ,the risk-adjusted value of ,federal ,government subsidies and investments related to the prescription drug4 7,f7 ,the costs associated with the development of the prescription drug4 7,g7 ,the number of similarly effective prescription drugs or alternative treatment regimens for each approved use of such prescription drug4 7,h7 ,whether the prescription drug provided a significant improvement in health outcomes1 compared to other therapies available at the time of its approval1 as determined through clinical effectiveness4 7,i7 ,the current wholesale acquisition cost of comparable prescription drugs in the ,united ,states1 to the extent that those prices have been deemed appropriate4 7,j7 ,the cumulative and expected global revenue generated by the prescription drug4 7,k7 ,the price of the drug in other countries1 including in the prescription drug reference countries4 7,l7 ,the public health benefit of the drug4 7,m7 ,the information that the manufacturer submits to the ,bureau as required under this section4 7,n7 ,any other information1 as the ,bureau requires4 7#b7 ,special rules 7,a7 ,interim appropriate price of prescription drugs 7i7 ,in general ,for each prescription drug described in clause 7ii71 the ,bureau shall-- 7,i7 establish an interim appropriate price1 which shall be the lesser of-- 7aa7 the median list price of the prescription drug in the prescription drug reference countries2 or 7bb7 if applicable1 the appropriate price determination made by the ,bureau2 and 7,,ii7 direct the manufacturer to set the wholesale acquisition cost at a level that does not exceed the interim appropriate price4 7ii7 ,applicable drugs ,a prescription drug described in this clause is a prescription drug-- 7,i7 that-- 7aa7 as of the date of the enactment of this ,act1 has in effect an application approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77 or section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a772 and 7bb7 is not a listed drug or a reference product for more than #b prescription drugs or biological products approved and currently marketed under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 or under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k772 or 7,,ii7 with respect to which the ,secretary has authorized under subsection 7g7 the use of any patent1 clinical trial data1 or other government-granted exclusivity related to such drug by another sponsor1 until the date that is #a year after the date on which another application for such drug1 for which the sponsor relies upon a such authorization under subsection 7g71 is approved under such section #eje or such section #cea4 7,b7 ,spike in price ,if a manufacturer increases the wholesale acquisition cost of a prescription drug by more than the percentage by which the ,consumer ,price ,index for ,all ,urban ,consumers for that year exceeds such index for the preceding calendar year1 such prescription drug shall be deemed to have a wholesale acquisition cost that is not appropriate unless the ,bureau determines1 based on the information submitted under paragraphs 7#b7 and 7#c7 of subsection 7a7 and under subsection 7b77#b7 and the considerations described in paragraph 7#a71 that the wholesale acquisition cost is appropriate4 7#c7 ,opportunity to comment ,prior to making a determination on whether the wholesale acquisition cost of a prescription drug is appropriate1 the ,bureau shall ensure relevant stakeholders1 including patients1 have an opportunity to comment4 7f7 ,required actions if price is not appropriate 7#a7 ,notice and requirement to remit excess ,if the ,bureau determines that the wholesale acquisition cost of a prescription drug is not appropriate1 the ,bureau shall notify and direct the manufacturer to lower the wholesale acquisition cost to a level that would be deemed appropriate4 ,the ,bureau shall also require the manufacturer to remit the excess revenue earned as a result of the prescription drug having a price that is not appropriate4 7#b7 ,patient rebate ,the ,director of the ,bureau shall establish a process to distribute funds remitted under paragraph 7#a7 to patients who were impacted by the prescription drug having a price that is not appropriate4 7g7 ,enforcement 7#a7 ,in general ,if1 within #cj days of receiving a notice that the wholesale acquisition cost of a prescription drug is not appropriate1 the manufacturer of such prescription drug fails to lower the wholesale acquisition cost of a prescription drug or fails to remit excessive revenue earned in accordance with subsection 7f71 the ,director shall notify the ,secretary and the ,secretary shall authorize the use of any patent1 clinical trial data1 or other government-granted exclusivity by an entity for purposes of manufacturing such prescription drug for sale4 ,an entity that wishes to manufacture such prescription drug for sale must agree to-- 7,a7 set the wholesale acquisition cost of such prescription drug at or below the level that the ,bureau determines is appropriate2 and 7,b7 provide the prescription drug manufacturer with reasonable compensation1 which shall be determined by the ,bureau1 based on the information submitted by the manufacturer under this section including-- 7i7 the risk-adjusted value of any ,federal ,government subsidies and investments in research and development used to support the development of such drug2 7ii7 the risk-adjusted value of any investment made by such manufacturer in the research and development of such drug2 7iii7 the impact of the price1 including license compensation payments1 on meeting the medical need of all patients2 7iv7 the relationship between the price of such drug1 including compensation payments and the health benefits of such drug2 and 7v7 other relevant information determined appropriate by the ,secretary1 in coordination with the ,director4 7#b7 ,post licensing 7,a7 ,in general ,any manufacturer of a prescription drug that fails to comply with the interim appropriate price under subsection 7e77#b77;,a77i77,i7 shall be subject to a civil monetary penalty of not less than an amount equal to #aej percent of all revenues obtained by the manufacturer that are in excess of the expected revenues at the interim appropriate price4 7,b7 ,procedure ,the provisions of section #aabh;,a1 other than subsections 7a7 and 7b7 and the first sentence of subsection 7c77#a7 of such section1 shall apply to civil monetary penalties under this paragraph in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a4 7,c7 ,transfer to ,national ,institutes of ,health ,the civil monetary penalties collected under this paragraph shall be transferred to the ,national ,institutes of ,health to supplement activities related to pharmaceutical research and development4 7h7 ,definitions ,in this ,act3 7#a7 ,conflict of interest ,the term conflict of interest means an association1 including a financial or personal association1 or past employment1 that has the potential to bias or have the appearance of biasing an individual's decisions4 7#b7 ,excess revenue ,the term excess revenue means the difference between a prescription drug's wholesale acquisition cost at the time of the ,bureau review under this section and the maximum wholesale acquisition price for the prescription drugs that the ,bureau determines to be appropriate4 7#c7 ,government-granted exclusivity ,the term government-granted exclusivity means prohibitions on the submission or effective approval of prescription drug applications granted under any of the following3 7,a7 ,clauses 7ii7 through 7v7 of section #eje7;c77#c77;,e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77#c77;,e774 7,b7 ,section #eje7;j77#e77;,b77iv7 of such ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b77iv77 or clause 7ii71 7iii71 or 7iv7 of section #eje7;j77#e77;,f7 of such ,act4 7,c7 ,section #eje;,a of such ,act 7#ba ,u4,s4,c4 #cee;a74 7,d7 ,section #eje;,e of such ,act 7#ba ,u4,s4,c4 #cee;f74 7,e7 ,section #ebg of such ,act 7#ba ,u4,s4,c4 #cfj;cc74 7,f7 ,section #cea7k77#g7 of such ,act 7#db ,u4,s4,c4 #bfb7k77#g774 7,g7 ,any other provision of law that provides for exclusivity 7or extension of exclusivity7 with respect to a drug4 7#d7 ,listed drug ,the term listed drug means a drug listed under section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g774 7#e7 ,manufacturer ,the term manufacturer1 with respect to a prescription drug1 means an entity that-- 7,a7 is the holder of the approved application under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb72 and 7,b7 is responsible for setting the price of the prescription drug4 7#f7 ,prescription drug ,the term prescription drug means any drug subject to section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea of the ,public ,health ,service ,act and to section #ejc7;b77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;b77#b774 7#g7 ,prescription drug reference country ,the term prescription drug reference country means ,japan1 ,germany1 the ,united ,kingdom1 ,france1 ,italy1 ,canada1 ,australia1 ,spain1 the ,netherlands1 ,switzerland1 and ,sweden4 7#h7 ,reference product ,the term reference product has the meaning given the term in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i774 7#i7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services4 7#aj7 ,wholesale acquisition cost ,the term wholesale acquisition cost has the meaning given that term in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 #d4 ,repeal of ,medicare's noninterference clause ,section #ahfj;,d-#aa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7 is amended by striking subsection 7i74