,i #aadth ,,congress #ast ,session ,h4 ,r4 #ceac ,,in ,,the ,,house ,,of ,,representatives ,september #af1 #bjae ,mr4 ,cummings 7for himself1 ,mr4 ,ellison1 ,ms4 ,norton1 and ,mr4 ,sarbanes7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committees on ,ways and ,means and the ,judiciary1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to ensure greater affordability of prescription drugs4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,prescription ,drug ,affordability ,act of #bjae4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,title ,i--,drugs under the ,medicare program ,sec4 #aja4 ,negotiation of lower covered part ,d drug prices on behalf of ,medicare beneficiaries4 ,sec4 #ajb4 ,acceleration of the closing of the ,medicare ,part ,d donut hole4 ,title ,,ii--,prescription drug importation ,sec4 #bja4 ,prescription drug importation4 ,sec4 #bjb4 ,sense of the ,house of ,representatives regarding trade agreements4 ,title ,,iii--,medicare and ,medicaid rebates ,sec4 #cja4 ,requiring drug manufacturers to provide drug rebates for drugs dispensed to low-income individuals4 ,sec4 #cjb4 ,applying the ,medicaid additional rebate requirement to generic drugs4 ,title ,,iv--,pay-for-delay blocking ,sec4 #dja4 ,preserving access to affordable generics4 ,title ,v--,fraud ,sec4 #eja4 ,conditions on award of drug exclusivity4 ,title ,,vi--,transparency ,sec4 #fja4 ,drug manufacturer reporting4 ,i ,drugs under the ,medicare program #aja4 ,negotiation of lower covered part ,d drug prices on behalf of ,medicare beneficiaries 7a7 ,negotiation by ,secretary ,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 inserting the following3 7i7 ,negotiation of ,lower ,drug ,prices 7#a7 ,in general ,notwithstanding any other provision of law1 the ,secretary shall negotiate with pharmaceutical manufacturers the prices 7including discounts1 rebates1 and other price concessions7 that may be charged to ,,pdp sponsors and ,,ma organizations for covered part ,d drugs for part ,d eligible individuals who are enrolled under a prescription drug plan or under an ,,ma-,,pd plan4 7#b7 ,no change in rules for formularies 7,a7 ,in general ,nothing in paragraph 7#a7 shall be construed to authorize the ,secretary to establish or require a particular formulary4 7,b7 ,construction ,subparagraph 7,a7 shall not be construed as affecting the ,secretary's authority to ensure appropriate and adequate access to covered part ,d drugs under prescription drug plans and under ,,ma-,,pd plans1 including compliance of such plans with formulary requirements under section #ahfj;,d-#d7;b77#c74 7#c7 ,construction ,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#a74 4 7b7 ,effective date ,the amendment made by subsection 7a7 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 #bjaf4 #ajb4 ,acceleration of the closing of the ,medicare ,part ,d donut hole 7a7 ,reduction in coinsurance ,section #ahfj;,d-#b7;b77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#b77 is amended-- 7#a7 in each of subclauses 7,,ii7 and 7,,iii7 of subparagraph 7,c77ii71 by striking #bjbj and inserting #bjag2 and 7#b7 in subparagraph 7,d77ii7-- 7,a7 in subclause 7,,ii71 by inserting and at the end2 and 7,b7 by striking clauses 7,,iii7 through 7,,vi7 and inserting the following3 7,,iii7 #bjag is #ajj percent4 4 7b7 ,increase in manufacturer rebate ,section #ahfj;,d-#ad;,a7g77#d77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad;a7g77#d77;,a77 is amended by inserting 7or1 for #bjag and subsequent years1 #ge percent7 after #ej percent4 ,,ii ,prescription drug importation #bja4 ,prescription drug importation 7a7 ,importation by pharmacists and wholesalers ,section #hjd7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd7;b77 is amended by striking ,the ,secretary1 and inserting ,the ,secretary1 not later than ,january #a1 #bjaf14 7b7 ,importation by individuals 7#a7 ,in general ,section #hjd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd7 is amended-- 7,a7 in subsection 7f71 by striking within ,canada2 7,b7 in subsection 7j7-- 7i7 in paragraph 7#a71 in the matter preceding subparagraph 7,a71 by inserting from countries other than ,canada after devices2 and 7ii7 in paragraph 7#c7-- 7,i7 in the heading1 by striking from ,canada and inserting from countries other than ,canada2 and 7,,ii7 in subparagraph 7,c71 by striking from ,canada12 and 7,c7 by striking subsection 7l7 and inserting the following3 7l7 ,importation of prescription drugs from ,canada ,individuals may import from ,canada any prescription drug that meets the requirements of subparagraphs 7,a7 through 7,f7 of subsection 7j77#c74 4 7#b7 ,regulations ,not later than ,january #a1 #bjaf1 the ,secretary of ,health and ,human ,services shall promulgate regulations with respect to subsection 7l7 of section #hjd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd7 7as amended by paragraph 7#a77;,b774 7#c7 ,effective date ,the amendments made by paragraph 7#a7 shall take effect on the effective date of the final regulations promulgated in accordance with paragraph 7#b74 7c7 ,,fdasia amendment ,subsection 7c7 of section #gjh of the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add2 #abf ,stat4 #ajfh7 is amended by striking ,the amendment made by and all that follows through the period at the end and inserting ,the amendment made by subsection 7a7 and the regulations promulgated under subsection 7b7 shall apply beginning on the effective date of the regulations promulgated under section #hjd7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd7;b77 and the amendments made by section #bja7;b7 of the ,prescription ,drug ,affordability ,act of #bjae44 #bjb4 ,sense of the ,house of ,representatives regarding trade agreements ,it is the sense of the ,house of ,representatives that the ,united ,states ,trade ,representative should not negotiate trade agreements that would raise the prices of prescription drugs in the ,united ,states1 extend the periods of market exclusivity otherwise available for prescription drugs1 or remove flexibility in ,federal or ,state law regarding pricing of prescription drugs4 ,,iii ,medicare and ,medicaid rebates #cja4 ,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 #bjag1 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 #bjaf 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 #bjaf1 and ending on ,december #ca1 #bjaf1 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 #bjae1 in the amount specified in paragraph 7#c7 for any covered part ,d drug of the manufacturer dispensed after ,december #ca1 #bjae1 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#g71 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 period1 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#g77;,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#g73 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#g7 ,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 #bjag1 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,d7 ,reporting requirement related to rebate for rebate eligible ,medicare drug plan enrollees ,section #ahfj;,d-#ab7;b77#g74 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 #cjb4 ,applying the ,medicaid additional rebate requirement to generic drugs 7a7 ,in general ,section #aibg7;c77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#c77 is amended-- 7#a7 in subparagraph 7,a71 by striking ,the amount and inserting ,except as provided in subparagraph 7,c71 the amount2 and 7#b7 by adding at the end the following new subparagraph3 7,c7 ,additional rebate 7i7 ,in general ,the amount of the rebate specified in this paragraph for a rebate period1 with respect to each dosage form and strength of a covered outpatient drug other than a single source drug or an innovator multiple source drug1 shall be increased in the manner that the rebate for a dosage form and strength of a single source drug or an innovator multiple source drug is increased under subparagraphs 7,a7 and 7,d7 of paragraph 7#b71 except as provided in clause 7ii74 7ii7 ,special rules for application of provision ,in applying subparagraphs 7,a7 and 7,d7 of paragraph 7#b7 under clause 7i7-- 7,i7 the reference in subparagraph 7,a77i7 of such paragraph to #aiij shall be deemed a reference to #bjad2 7,,ii7 subject to clause 7iii71 the reference in subparagraph 7,a77ii7 of such paragraph to calendar quarter beginning ,july #a1 #aiij shall be deemed a reference to the calendar quarter in which the average manufacturer price for the drug is the lowest during the #ab-;calendar quarter period ending on ,september #cj1 #bjad2 7,,iii7 subject to clause 7iii71 the reference in subparagraph 7,a77ii7 of such paragraph to ,september #aiij shall be deemed a reference to the last month of such calendar quarter2 7,,iv7 the references in subparagraph 7,d7 of such paragraph to paragraph 7#a77;,a77ii71 this paragraph1 and ,december #ca1 #bjji shall be deemed references to subparagraph 7,a71 this subparagraph1 and ,december #ca1 #bjad1 respectively2 and 7,v7 any reference in such paragraph to a single source drug or an innovator multiple source drug shall be deemed to be a reference to a drug to which clause 7i7 applies4 7iii7 ,special rule for certain noninnovator multiple source drugs ,in applying paragraph 7#b77;,a77ii77,,ii7 under clause 7i7 with respect to a covered outpatient drug that is first sold as a drug other than a single source drug or an innovator multiple source drug after the date that is #c years before the date of the enactment of this subparagraph1 such paragraph shall be applied-- 7,i7 by substituting the applicable quarter for the calendar quarter beginning ,july #a1 #aiij2 and 7,,ii7 by substituting the last month in such applicable quarter for ,september #aiij4 7iv7 ,applicable quarter defined ,in this subsection1 the term applicable quarter means1 with respect to a drug described in clause 7iii71 the fifth full calendar quarter in which the drug is sold as a drug other than a single source drug or an innovator multiple source drug4 4 7b7 ,effective date ,the amendments made by subsection 7a7 shall apply to rebate periods beginning after ,december #ca1 #bjad4 ,,iv ,pay-for-delay blocking #dja4 ,preserving access to affordable generics ,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 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 product4 7#b7 ,presumption and violation ,in such a proceeding1 an agreement shall be presumed to have anticompetitive effects and be a violation of this section if-- 7,a7 an ,,anda filer receives anything of value1 including an exclusive license2 and 7,b7 the ,,anda filer agrees to limit or forego research1 development1 manufacturing1 marketing1 or sales of the ,,anda product for any period of time4 7b7 ,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 to the ,,anda filer as part of the resolution or settlement includes only one or more of the following3 7#a7 ,the right to market the ,,anda 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 drug4 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 infringes a ,united ,states patent4 7c7 ,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 ,commission of ,food and ,drugs 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 ,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#g7 ,,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#h7 ,,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#i7 ,party ,the term party means any person1 partnership1 corporation1 or other legal entity4 7#aj7 ,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#aa7 ,patent infringement claim ,the term patent infringement claim means any allegation made to an ,,anda filer1 whether or not included in a complaint filed with a court of law1 that its ,,anda or ,,anda product may infringe any patent held by1 or exclusively licensed to1 the ,,nda holder of the drug product4 7#ab7 ,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;a74 4 ,v ,fraud #eja4 ,conditions on award of drug exclusivity ,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;,d4 ,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-- 7#a7 commits a violation described in subsection 7c77#a7 with respect to such drug2 or 7#b7 fails to report such a violation as required by subsection 7e74 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#b7 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 ,the provisions of subchapter ,,iii of chapter #cg of title #ca1 ,united ,states ,code 7commonly known as the ,false ,claims ,act74 7,c7 ,section #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 ,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 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 4 ,,vi ,transparency #fja4 ,drug manufacturer reporting 7a7 ,reporting on domestic sales ,the manufacturer of a 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 shall submit to the ,secretary of ,health and ,human ,services and to ,congress an annual report1 which shall be made publicly available1 outlining with respect to each such drug1 during the previous calendar year-- 7#a7 the total expenditures of the manufacturer on-- 7,a7 drug research and development2 7,b7 clinical trials2 7,c7 materials and manufacturing2 7,d7 acquisition costs1 including costs for the purchase of patents and licensing2 and 7,e7 marketing and advertising for the promotion of the drug to consumers and prescribers2 7#b7 the total profit to the manufacturer attributable to such drug2 7#c7 the total amount of financial assistance the manufacturer has provided through patient prescription assistance programs with respect to such drug1 if any2 7#d7 any ,federal benefits received by the manufacturer1 including tax credits1 grants from the ,national ,institutes of ,health1 and other ,federal benefits with respect to such drug2 and 7#e7 any additional information the manufacturer chooses to provide related to drug pricing decisions1 such as total expenditures on drug research and development or clinical trials on drugs that failed to receive approval by the ,food and ,drug ,administration4 7b7 ,reporting on foreign sales ,in the case of a manufacturer of a drug that sells such drug to the ,federal ,government1 including through the health programs of the ,department of ,veterans ,affairs1 the ,department of ,defense1 and the ,indian ,health ,service and through the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq471 or that has entered into an agreement under section #cdj;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b71 the manufacturer shall include in the report submitted under subsection 7a7 information about the price of the drug1 and profits from and volume of sales of the drug1 in each foreign country in which the drug is sold1 as applicable4