,i #aafth ,,congress #ast ,session ,h4 ,r4 #bgjj ,,in ,,the ,,house ,,of ,,representatives ,may #ad1 #bjai,mr4 ,burgess 7for himself1 ,mr4 ,walden1 ,mr4 ,upton1 ,mr4 ,mc,kinley1 ,mr4 ,carter of ,georgia1 ,mr4 ,bucshon1 ,mr4 ,bilirakis1 ,mr4 ,mullin1 ,mrs4 ,rodgers of ,washington1 ,mr4 ,long1 ,mr4 ,flores1 ,mr4 ,hudson1 ,mr4 ,shimkus1 ,mr4 ,walberg1 ,mr4 ,kinzinger1 ,mr4 ,olson1 ,mr4 ,johnson of ,ohio1 ,mr4 ,guthrie1 ,mr4 ,griffith1 ,mr4 ,duncan1 ,mrs4 ,brooks of ,indiana1 ,mr4 ,gianforte1 ,mr4 ,latta1 ,mr4 ,scalise1 ,mr4 ,sensenbrenner1 ,mr4 ,collins of ,georgia1 ,mr4 ,stivers1 ,mr4 ,hill of ,arkansas1 ,mr4 ,mitchell1 and ,mr4 ,hurd of ,texas7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on 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 incentivize low-cost drug options and generic competition1 and to provide extensions for community health centers and the ,national ,health ,service ,corps1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,lowering ,prescription ,drug ,costs and ,extending ,community ,health ,centers and ,other ,public ,health ,priorities ,act4 #b4 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title4 ,sec4 #b4 ,table of contents4 ,title ,i--,lowering ,prescription ,drug ,costs ,subtitle ,a--,bringing ,low-,cost ,options and ,competition ,while ,keeping ,incentives for ,new ,generics ,sec4 #aja4 ,change conditions of first generic exclusivity to spur access and competition4 ,subtitle ,b--,protecting ,consumer ,access to ,generic ,drugs ,sec4 #aaa4 ,unlawful agreements4 ,sec4 #aab4 ,notice and certification of agreements4 ,sec4 #aac4 ,forfeiture of #ahj-;day exclusivity period4 ,sec4 #aad4 ,commission litigation authority4 ,sec4 #aae4 ,statute of limitations4 ,subtitle ,c--,creating and ,restoring ,equal ,access to ,equivalent ,samples ,sec4 #aba4 ,actions for delays of generic drugs and biosimilar biological products4 ,sec4 #abb4 ,,rems approval process for subsequent filers4 ,sec4 #abc4 ,rule of construction4 ,title ,,ii--,extension of ,public ,health ,programs ,sec4 #bja4 ,extension for community health centers1 the ,national ,health ,service ,corps1 and teaching health centers that operate ,,gme programs4 ,sec4 #bjb4 ,extension for special diabetes programs4 ,sec4 #bjc4 ,extension for family-to-family health information centers4 ,sec4 #bjd4 ,extension for sexual risk avoidance education and personal responsibility education4 ,i ,lowering ,prescription ,drug ,costs ,a ,bringing ,low-,cost ,options and ,competition ,while ,keeping ,incentives for ,new ,generics #aja4 ,change conditions of first generic exclusivity to spur access and competition ,section #eje7;j77#e77;,b77iv7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b77iv77 is amended-- 7#a7 in subclause 7,i71 by striking #ahj days after and all that follows through the period at the end and inserting the following3 #ahj days after the earlier of-- 7aa7 the date of the first commercial marketing of the drug 7including the commercial marketing of the listed drug7 by any first applicant2 or 7bb7 the applicable date specified in subclause 7,,iii74 2 and 7#b7 by adding at the end the following new subclause3 7,,iii7 ,applicable date ,the applicable date specified in this subclause1 with respect to an application for a drug described in subclause 7,i71 is the date on which each of the following conditions is first met3 7aa7 ,the approval of such an application could be made effective1 but for the eligibility of a first applicant for #ahj-;day exclusivity under this clause4 7bb7 ,at least #cj months have passed since the date of submission of an application for the drug by at least one first applicant4 7cc7 ,approval of an application for the drug submitted by at least one first applicant is not precluded under clause 7iii74 7dd7 ,no application for the drug submitted by any first applicant is approved at the time the conditions under items 7aa71 7bb71 and 7cc7 are all met1 regardless of whether such an application is subsequently approved4 4 ,b ,protecting ,consumer ,access to ,generic ,drugs #aaa4 ,unlawful agreements 7a7 ,agreements prohibited ,subject to subsections 7b7 and 7c71 it shall be unlawful for an ,,nda or ,,bla holder and a subsequent filer 7or for two subsequent filers7 to enter into1 or carry out1 an agreement resolving or settling a covered patent infringement claim on a final or interim basis if under such agreement-- 7#a7 a subsequent filer directly or indirectly receives from such holder 7or in the case of such an agreement between two subsequent filers1 the other subsequent filer7 anything of value1 including a license2 and 7#b7 the subsequent filer agrees to limit or forego research on1 or development1 manufacturing1 marketing1 or sales1 for any period of time1 of the covered product that is the subject of the application described in subparagraph 7,a7 or 7,b7 of subsection 7g77#h74 7b7 ,exclusion ,it shall not be unlawful under subsection 7a7 if a party to an agreement described in such subsection demonstrates by clear and convincing evidence that the value described in subsection 7a77#a7 is compensation solely for other goods or services that the subsequent filer has promised to provide4 7c7 ,limitation ,nothing in this section shall prohibit an agreement resolving or settling a covered patent infringement claim in which the consideration granted by the ,,nda or ,,bla holder to the subsequent filer 7or from one subsequent filer to another7 as part of the resolution or settlement includes only one or more of the following3 7#a7 ,the right to market the covered product that is the subject of the application described in subparagraph 7,a7 or 7,b7 of subsection 7g77#h7 in the ,united ,states before the expiration of-- 7,a7 any patent that is the basis of the covered patent infringement claim2 or 7,b7 any patent right or other statutory exclusivity that would prevent the marketing of such covered product4 7#b7 ,a payment for reasonable litigation expenses not to exceed #g1ejj1jjj in the aggregate4 7#c7 ,a covenant not to sue on any claim that such covered product infringes a patent4 7d7 ,enforcement by ,federal ,trade ,commission 7#a7 ,general application ,the requirements of this section apply1 according to their terms1 to an ,,nda or ,,bla holder or subsequent filer that is-- 7,a7 a person1 partnership1 or corporation over which the ,commission has authority pursuant to section #e7;a77#b7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#b772 or 7,b7 a person1 partnership1 or corporation over which the ,commission would have authority pursuant to such section but for the fact that such person1 partnership1 or corporation is not organized to carry on business for its own profit or that of its members4 7#b7 ,unfair or deceptive acts or practices enforcement authority 7,a7 ,in general ,a violation of this section shall be treated as an unfair or deceptive act or practice in violation of section #e7;a77#a7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#a774 7,b7 ,powers of ,commission ,except as provided in subparagraph 7,c7 and paragraphs 7#a77;,b7 and 7#c7-- 7i7 the ,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 section2 and 7ii7 any ,,nda or ,,bla holder or subsequent filer that violates this section shall be subject to the penalties and entitled to the privileges and immunities provided in the ,federal ,trade ,commission ,act4 7,c7 ,judicial review ,in the case of a cease and desist order issued by the ,commission under section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 for violation of this section1 a party to such order may obtain judicial review of such order as provided in such section #e1 except that-- 7i7 such review may only be obtained in-- 7,i7 the ,united ,states ,court of ,appeals for the ,district of ,columbia ,circuit2 7,,ii7 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 or ,,bla holder 7if any such holder is a party to such order7 is incorporated as of the date that the application described in subparagraph 7,a7 or 7,b7 of subsection 7g77#h7 or an approved application that is deemed to be a license for a biological product under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji 7,public ,law #aaa-adh2 #abd ,stat4 #hag7 is submitted to the ,commissioner of ,food and ,drugs2 or 7,,iii7 the ,united ,states ,court of ,appeals for the circuit in which the ultimate parent entity1 as so defined1 of any subsequent filer that is a party to such order is incorporated as of the date that the application described in subparagraph 7,a7 or 7,b7 of subsection 7g77#h7 is submitted to the ,commissioner of ,food and ,drugs2 and 7ii7 the petition for review shall be filed in the court not later than #cj days after such order is served on the party seeking review4 7#c7 ,additional enforcement authority 7,a7 ,civil penalty ,the ,commission may commence a civil action to recover a civil penalty in a district court of the ,united ,states against any ,,nda or ,,bla holder or subsequent filer that violates this section4 7,b7 ,special rule for recovery of penalty if cease and desist order issued 7i7 ,in general ,if the ,commission has issued a cease and desist order in a proceeding under section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 for violation of this section-- 7,i7 the ,commission may commence a civil action under subparagraph 7,a7 to recover a civil penalty against any party to such order at any time before the expiration of the #a-year period beginning on the date on which such order becomes final under section #e7;g7 of such ,act 7#ae ,u4,s4,c4 #de7;g772 and 7,,ii7 in such civil action1 the findings of the ,commission as to the material facts in such proceeding shall be conclusive1 unless-- 7aa7 the terms of such order expressly provide that the ,commission's findings shall not be conclusive2 or 7bb7 such order became final by reason of section #e7;g77#a7 of such ,act 7#ae ,u4,s4,c4 #de7;g77#a771 in which case such findings shall be conclusive if supported by evidence4 7ii7 ,relationship to penalty for violation of an order ,the penalty provided in clause 7i7 for violation of this section is separate from and in addition to any penalty that may be incurred for violation of an order of the ,commission under section #e7l7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7l774 7,c7 ,amount of penalty 7i7 ,in general ,the amount of a civil penalty imposed in a civil action under subparagraph 7,a7 on a party to an agreement described in subsection 7a7 shall be sufficient to deter violations of this section1 but in no event greater than-- 7,i7 if such party is the ,,nda or ,,bla holder 7or1 in the case of an agreement between two subsequent filers1 the subsequent filer who gave the value described in subsection 7a77#a771 the greater of-- 7aa7 #c times the value received by such ,,nda or ,,bla holder 7or by such subsequent filer7 that is reasonably attributable to the violation of this section2 or 7bb7 #c times the value given to the subsequent filer 7or to the other subsequent filer7 reasonably attributable to the violation of this section2 and 7,,ii7 if such party is the subsequent filer 7or1 in the case of an agreement between two subsequent filers1 the subsequent filer who received the value described in subsection 7a77#a771 #c times the value received by such subsequent filer that is reasonably attributable to the violation of this section4 7ii7 ,factors for consideration ,in determining such amount1 the court shall take into account-- 7,i7 the nature1 circumstances1 extent1 and gravity of the violation2 7,,ii7 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 or ,,bla holder 7or1 in the case of an agreement between two subsequent filers1 the subsequent filer who gave the value described in subsection 7a77#a771 compensation received by the subsequent filer 7or1 in the case of an agreement between two subsequent filers1 the subsequent filer who received the value described in subsection 7a77#a771 and the amount of commerce affected2 and 7,,iii7 other matters that justice requires4 7,d7 ,injunctions and other equitable relief ,in a civil action under subparagraph 7,a71 the ,united ,states district courts are empowered to grant mandatory injunctions and such other and further equitable relief as they deem appropriate4 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 7#e7 ,preservation of authority of ,commission ,nothing in this section shall be construed to affect any authority of the ,commission under any other provision of law4 7e7 ,federal ,trade ,commission rulemaking ,the ,commission may1 in its discretion1 by rule promulgated under section #eec of title #e1 ,united ,states ,code1 exempt from this section certain agreements described in subsection 7a7 if the ,commission finds such agreements to be in furtherance of market competition and for the benefit of consumers4 7f7 ,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 the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to the extent that such section #e applies to unfair methods of competition4 ,nothing in this section shall modify1 impair1 limit1 or supersede the right of a subsequent filer to assert claims or counterclaims against any person1 under the antitrust laws or other laws relating to unfair competition4 7g7 ,definitions ,in this section3 7#a7 ,agreement resolving or settling a covered patent infringement claim ,the term agreement resolving or settling a covered patent infringement claim means any agreement that-- 7,a7 resolves or settles a covered patent infringement claim2 or 7,b7 is contingent upon1 provides for a contingent condition for1 or is otherwise related to the resolution or settlement of a covered patent infringement claim4 7#b7 ,commission ,the term ,commission means the ,federal ,trade ,commission4 7#c7 ,covered patent infringement claim ,the term covered patent infringement claim means an allegation made by the ,,nda or ,,bla holder to a subsequent filer 7or1 in the case of an agreement between two subsequent filers1 by one subsequent filer to another71 whether or not included in a complaint filed with a court of law1 that-- 7,a7 the submission of the application described in subparagraph 7,a7 or 7,b7 of paragraph 7#i71 or the manufacture1 use1 offering for sale1 sale1 or importation into the ,united ,states of a covered product that is the subject of such an application-- 7i7 in the case of an agreement between an ,,nda or ,,bla holder and a subsequent filer1 infringes any patent owned by1 or exclusively licensed to1 the ,,nda or ,,bla holder of the covered product2 or 7ii7 in the case of an agreement between two subsequent filers1 infringes any patent owned by the subsequent filer2 or 7,b7 in the case of an agreement between an ,,nda or ,,bla holder and a subsequent filer1 the covered product to be manufactured under such application uses a covered product as claimed in a published patent application4 7#d7 ,covered product ,the term covered product means a drug 7as defined in section #bja7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g7771 including a biological product 7as defined in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i774 7#e7 ,,nda or ,,bla holder ,the term ,,nda or ,,bla holder means-- 7,a7 the holder of-- 7i7 an approved new drug application filed under section #eje7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 for a covered product2 or 7ii7 a biologics license application filed under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77 with respect to a biological product2 7,b7 a person owning or controlling enforcement of the patent on-- 7i7 the list published under section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 in connection with the application described in subparagraph 7,a77i72 or 7ii7 any list published under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 comprised of patents associated with biologics license applications filed under section #cea7;a7 of such ,act 7#db ,u4,s4,c4 #bfb7;a772 or 7,c7 the predecessors1 subsidiaries1 divisions1 groups1 and affiliates controlled by1 controlling1 or under common control with any entity described in subparagraph 7,a7 or 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#f7 ,patent ,the term patent means a patent issued by the ,united ,states ,patent and ,trademark ,office4 7#g7 ,statutory exclusivity ,the term statutory exclusivity means those prohibitions on the submission or approval of drug applications under clauses 7ii7 through 7iv7 of section #eje7;c77#c77;,e7 7#e- and #c-year exclusivity71 clauses 7ii7 through 7iv7 of section #eje7;j77#e77;,f7 7#e-year and #c-year exclusivity71 section #eje7;j77#e77;,b77iv7 7#ahj-;day exclusivity71 section #ebg 7orphan drug exclusivity71 section #eje;,a 7pediatric exclusivity71 or section #eje;,e 7qualified infectious disease product exclusivity7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77#c77;,e71 #cee7;j77#e77;,b77iv71 #cee7;j77#e77;,f71 #cfj;cc1 #cee;a1 #cee;f71 or prohibitions on the submission or licensing of biologics license applications under section #cea7k77#f7 7interchangeable biological product exclusivity7 or section #cea7k77#g7 7biological product reference product exclusivity7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#f71 7#g774 7#h7 ,subsequent filer ,the term subsequent filer means-- 7,a7 in the case of a drug1 a party that owns or controls an abbreviated new drug application submitted pursuant to section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 or a new drug application submitted pursuant to section #eje7;b77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba,u4,s4,c4 #cee7;b77#b77 and filed under section #eje7;b77#a7 of such ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 or has the exclusive rights to distribute the covered product that is the subject of such application2 or 7,b7 in the case of a biological product1 a party that owns or controls an application filed with the ,food and ,drug ,administration under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 or has the exclusive rights to distribute the biological product that is the subject of such application4 7h7 ,effective date ,this section applies with respect to agreements described in subsection 7a7 entered into on or after the date of the enactment of this ,act4 #aab4 ,notice and certification of agreements 7a7 ,notice of all agreements ,section #aaaa7g7 of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc 7#ba ,u4,s4,c4 #cee note7 is amended by inserting or the owner of a patent for which a claim of infringement could reasonably be asserted against any person for making1 using1 offering to sell1 selling1 or importing into the ,united ,states a biological product that is the subject of a biosimilar biological product application before the period at the end4 7b7 ,certification of agreements ,section #aaab of such ,act 7#ba ,u4,s4,c4 #cee note7 is amended by adding at the end the following3 7d7 ,certification ,the ,chief ,executive ,officer or the company official responsible for negotiating any agreement under subsection 7a7 or 7b7 that is required to be filed under subsection 7c7 shall1 within #cj days of such filing1 execute and file with the ,assistant ,attorney ,general and the ,commission a certification as follows3 ,i declare that the following is true1 correct1 and complete to the best of my knowledge3 ,the materials filed with the ,federal ,trade ,commission and the ,department of ,justice under section #aaab of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc1 with respect to the agreement referenced in this certification-- 7#a7 represent the complete1 final1 and exclusive agreement between the parties2 7#b7 include any ancillary agreements that are contingent upon1 provide a contingent condition for1 were entered into within #cj days of1 or are otherwise related to1 the referenced agreement2 and 7#c7 include written descriptions of any oral agreements1 representations1 commitments1 or promises between the parties that are responsive to subsection 7a7 or 7b7 of such section #aaab and have not been reduced to writing4 4 4 #aac4 ,forfeiture of #ahj-;day exclusivity period ,section #eje7;j77#e77;,d77i77,v7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,d77i77,v77 is amended by inserting section #aaa of the ,lowering ,prescription ,drug ,costs and ,extending ,community ,health ,centers and ,other ,public ,health ,priorities ,act or after that the agreement has violated4 #aad4 ,commission litigation authority ,section #af7;a77#b7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #ef7;a77#b77 is amended-- 7#a7 in subparagraph 7,d71 by striking or after the semicolon2 7#b7 in subparagraph 7,e71 by inserting or after the semicolon2 and 7#c7 by inserting after subparagraph 7,e7 the following3 7,f7 under section #aaa7;d77#c77;,a7 of the ,lowering ,prescription ,drug ,costs and ,extending ,community ,health ,centers and ,other ,public ,health ,priorities ,act2 4 #aae4 ,statute of limitations 7a7 ,in general ,except as provided in subsection 7b71 the ,commission shall commence any administrative proceeding or civil action to enforce section #aaa of this ,act not later than #f years after the date on which the parties to the agreement file the ,notice of ,agreement as provided by section #aaab7;c77#b7 and 7d7 of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc 7#ba ,u4,s4,c4 #cee note74 7b7 ,civil action after issuance of cease and desist order ,if the ,commission has issued a cease and desist order under section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 for violation of section #aaa of this ,act and the proceeding for the issuance of such order was commenced within the period required by subsection 7a7 of this section1 such subsection does not prohibit the commencement1 after such period1 of a civil action under section #aaa7;d77#c77;,a7 against a party to such order or a civil action under subsection 7l7 of such section #e for violation of such order4 ,c ,creating and ,restoring ,equal ,access to ,equivalent ,samples #aba4 ,actions for delays of generic drugs and biosimilar biological products 7a7 ,definitions ,in this section-- 7#a7 the term commercially reasonable1 market-based terms means-- 7,a7 a nondiscriminatory price for the sale of the covered product at or below1 but not greater than1 the most recent wholesale acquisition cost for the drug1 as defined in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b772 7,b7 a schedule for delivery that results in the transfer of the covered product to the eligible product developer consistent with the timing under subsection 7b77#b77;,a77iv72 and 7,c7 no additional conditions are imposed on the sale of the covered product2 7#b7 the term covered product-- 7,a7 means-- 7i7 any drug approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or biological product licensed under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb72 7ii7 any combination of a drug or biological product described in clause 7i72 or 7iii7 when reasonably necessary to support approval of an application under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 as applicable1 or otherwise meet the requirements for approval under either such section1 any product1 including any device1 that is marketed or intended for use with such a drug or biological product2 and 7,b7 does not include any drug or biological product that appears on the drug shortage list in effect under section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e71 unless-- 7i7 the drug or biological product has been on the drug shortage list in effect under such section #ejf;,e continuously for more than #f months2 or 7ii7 the ,secretary determines that inclusion of the drug or biological product as a covered product is likely to contribute to alleviating or preventing a shortage4 7#c7 the term device has the meaning given the term in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba72 7#d7 the term eligible product developer means a person that seeks to develop a product for approval pursuant to an application for approval under subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or for licensing pursuant to an application under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k772 7#e7 the term license holder 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 the holder of a license under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 for a covered product2 7#f7 the term ,,rems means a risk evaluation and mitigation strategy under section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a72 7#g7 the term ,,rems with ,,etasu means a ,,rems that contains elements to assure safe use under section #eje-a7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f772 7#h7 the term ,secretary means the ,secretary of ,health and ,human ,services2 7#i7 the term single1 shared system of elements to assure safe use means a single1 shared system of elements to assure safe use under section #eje-a7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f772 and 7#aj7 the term sufficient quantities means an amount of a covered product that the eligible product developer determines allows it to-- 7,a7 conduct testing to support an application under-- 7i7 subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 or 7ii7 section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k772 and 7,b7 fulfill any regulatory requirements relating to approval of such an application4 7b7 ,civil action for failure ,to provide sufficient quantities of a covered product 7#a7 ,in general ,an eligible product developer may bring a civil action against the license holder for a covered product seeking relief under this subsection in an appropriate district court of the ,united ,states alleging that the license holder has declined to provide sufficient quantities of the covered product to the eligible product developer on commercially reasonable1 market-based terms4 7#b7 ,elements 7,a7 ,in general ,to prevail in a civil action brought under paragraph 7#a71 an eligible product developer shall prove1 by a preponderance of the evidence-- 7i7 that-- 7,i7 the covered product is not subject to a ,,rems with ,,etasu2 or 7,,ii7 if the covered product is subject to a ,,rems with ,,etasu-- 7aa7 the eligible product developer has obtained a covered product authorization from the ,secretary in accordance with subparagraph 7,b72 and 7bb7 the eligible product developer has provided a copy of the covered product authorization to the license holder2 7ii7 that1 as of the date on which the civil action is filed1 the product developer has not obtained sufficient quantities of the covered product on commercially reasonable1 market-based terms2 7iii7 that the eligible product developer has submitted a written request to purchase sufficient quantities of the covered product to the license holder and such request-- 7,i7 was sent to a named corporate officer of the license holder2 7,,ii7 was made by certified or registered mail with return receipt requested2 7,,iii7 specified an individual as the point of contact for the license holder to direct communications related to the sale of the covered product to the eligible product developer and a means for electronic and written communications with that individual2 and 7,,iv7 specified an address to which the covered product was to be shipped upon reaching an agreement to transfer the covered product2 and 7iv7 that the license holder has not delivered to the eligible product developer sufficient quantities of the covered product on commercially reasonable1 market-based terms-- 7,i7 for a covered product that is not subject to a ,,rems with ,,etasu1 by the date that is #ca days after the date on which the license holder received the request for the covered product2 and 7,,ii7 for a covered product that is subject to a ,,rems with ,,etasu1 by #ca days after the later of-- 7aa7 the date on which the license holder received the request for the covered product2 or 7bb7 the date on which the license holder received a copy of the covered product authorization issued by the ,secretary in accordance with subparagraph 7,b74 7,b7 ,authorization for covered product subject to a ,,rems with ,,etasu 7i7 ,request ,an eligible product developer may submit to the ,secretary a written request for the eligible product developer to be authorized to obtain sufficient quantities of an individual covered product subject to a ,,rems with ,,etasu4 7ii7 ,authorization ,not later than #abj days after the date on which a request under clause 7i7 is received1 the ,secretary shall1 by written notice1 authorize the eligible product developer to obtain sufficient quantities of an individual covered product subject to a ,,rems with ,,etasu for purposes of-- 7,i7 development and testing that does not involve human clinical trials1 if the eligible product developer has agreed to comply with any conditions the ,secretary determines necessary2 or 7,,ii7 development and testing that involves human clinical trials1 if the eligible product developer has-- 7aa7 7,,aa7 submitted protocols1 informed consent documents1 and informational materials for testing that include protections that provide safety protections comparable to those provided by the ,,rems for the covered product2 or 7,,bb7 otherwise satisfied the ,secretary that such protections will be provided2 and 7bb7 met any other requirements the ,secretary may establish4 7iii7 ,notice ,a covered product authorization issued under this subparagraph shall state that the provision of the covered product by the license holder under the terms of the authorization will not be a violation of the ,,rems for the covered product4 7#c7 ,affirmative defense ,in a civil action brought under paragraph 7#a71 it shall be an affirmative defense1 on which the defendant has the burden of persuasion by a preponderance of the evidence-- 7,a7 that1 on the date on which the eligible product developer requested to purchase sufficient quantities of the covered product from the license holder-- 7i7 neither the license holder nor any of its agents1 wholesalers1 or distributors was engaged in the manufacturing or commercial marketing of the covered product2 and 7ii7 neither the license holder nor any of its agents1 wholesalers1 or distributors otherwise had access to inventory of the covered product to supply to the eligible product developer on commercially reasonable1 market-based terms2 7,b7 that-- 7i7 the license holder sells the covered product through agents1 distributors1 or wholesalers2 7ii7 the license holder has placed no restrictions1 explicit or implicit1 on its agents1 distributors1 or wholesalers to sell covered products to eligible product developers2 and 7iii7 the covered product can be purchased by the eligible product developer in sufficient quantities on commercially reasonable1 market-based terms from the agents1 distributors1 or wholesalers of the license holder2 or 7,c7 that the license holder made an offer to the individual specified pursuant to paragraph 7#b77;,a77iii77,,iii71 by a means of communication 7electronic1 written1 or both7 specified pursuant to such paragraph1 to sell sufficient quantities of the covered product to the eligible product developer at commercially reasonable market-based terms-- 7i7 for a covered product that is not subject to a ,,rems with ,,etasu1 by the date that is #ad days after the date on which the license holder received the request for the covered product1 and the eligible product developer did not accept such offer by the date that is #g days after the date on which the eligible product developer received such offer from the license holder2 or 7ii7 for a covered product that is subject to a ,,rems with ,,etasu1 by the date that is #bj days after the date on which the license holder received the request for the covered product1 and the eligible product developer did not accept such offer by the date that is #aj days after the date on which the eligible product developer received such offer from the license holder4 7#d7 ,remedies 7,a7 ,in general ,if an eligible product developer prevails in a civil action brought under paragraph 7#a71 the court shall-- 7i7 order the license holder to provide to the eligible product developer without delay sufficient quantities of the covered product on commercially reasonable1 market-based terms2 7ii7 award to the eligible product developer reasonable attorney's fees and costs of the civil action2 and 7iii7 award to the eligible product developer a monetary amount sufficient to deter the license holder from failing to provide eligible product developers with sufficient quantities of a covered product on commercially reasonable1 market-based terms1 if the court finds1 by a preponderance of the evidence-- 7,i7 that the license holder delayed providing sufficient quantities of the covered product to the eligible product developer without a legitimate business justification2 or 7,,ii7 that the license holder failed to comply with an order issued under clause 7i74 7,b7 ,maximum monetary amount ,a monetary amount awarded under subparagraph 7,a77iii7 shall not be greater than the revenue that the license holder earned on the covered product during the period-- 7i7 beginning on-- 7,i7 for a covered product that is not subject to a ,,rems with ,,etasu1 the date that is #ca days after the date on which the license holder received the request2 or 7,,ii7 for a covered product that is subject to a ,,rems with ,,etasu1 the date that is #ca days after the later of-- 7aa7 the date on which the license holder received the request2 or 7bb7 the date on which the license holder received a copy of the covered product authorization issued by the ,secretary in accordance with paragraph 7#b77;,b72 and 7ii7 ending on the date on which the eligible product developer received sufficient quantities of the covered product4 7,c7 ,avoidance of delay ,the court may issue an order under subparagraph 7,a77i7 before conducting further proceedings that may be necessary to determine whether the eligible product developer is entitled to an award under clause 7ii7 or 7iii7 of subparagraph 7,a71 or the amount of any such award4 7c7 ,limitation of liability ,a license holder for a covered product shall not be liable for any claim under ,federal1 ,state1 or local law arising out of the failure of an eligible product developer to follow adequate safeguards to assure safe use of the covered product during development or testing activities described in this section1 including transportation1 handling1 use1 or disposal of the covered product by the eligible product developer4 7d7 ,no violation of ,,rems ,section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7 is amended by adding at the end the following new subsection3 7l7 ,provision of samples not a violation of strategy ,the provision of samples of a covered product to an eligible product developer 7as those terms are defined in section #aba7;a7 of the ,lowering ,prescription ,drug ,costs and ,extending ,community ,health ,centers and ,other ,public ,health ,priorities ,act7 shall not be considered a violation of the requirements of any risk evaluation and mitigation strategy that may be in place under this section for such drug4 4 7e7 ,rule of construction 7#a7 ,definition ,in this subsection1 the term antitrust laws-- 7,a7 has the meaning given the term in subsection 7a7 of the first section of the ,clayton ,act 7#ae ,u4,s4,c4 #ab72 and 7,b7 includes section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to the extent that such section applies to unfair methods of competition4 7#b7 ,antitrust laws ,nothing in this section shall be construed to limit the operation of any provision of the antitrust laws4 #abb4 ,,rems approval process for subsequent filers ,section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71 as amended by section #aba1 is further amended-- 7#a7 in subsection 7g77#d77;,b7-- 7,a7 in clause 7i7 by striking or after the semicolon2 7,b7 in clause 7ii7 by striking the period at the end and inserting 2 or2 and 7,c7 by adding at the end the following3 7iii7 accommodate different1 comparable aspects of the elements to assure safe use for a drug that is the subject of an application under section #eje7;j71 and the applicable listed drug4 2 7#b7 in subsection 7i77#a71 by striking subparagraph 7,c7 and inserting the following3 7,c7 7i7 ,elements to assure safe use1 if required under subsection 7f7 for the listed drug1 which1 subject to clause 7ii71 for a drug that is the subject of an application under section #eje7;j7 may use-- 7,i7 a single1 shared system with the listed drug under subsection 7f72 or 7,,ii7 a different1 comparable aspect of the elements to assure safe use under subsection 7f74 7ii7 ,the ,secretary may require a drug that is the subject of an application under section #eje7;j7 and the listed drug to use a single1 shared system under subsection 7f71 if the ,secretary determines that no different1 comparable aspect of the elements to assure safe use could satisfy the requirements of subsection 7f74 2 7#c7 in subsection 7i71 by adding at the end the following3 7#c7 ,shared ,,rems ,if the ,secretary approves1 in accordance with paragraph 7#a77;,c77i77,,ii71 a different1 comparable aspect of the elements to assure safe use under subsection 7f7 for a drug that is the subject of an abbreviated new drug application under section #eje7;j71 the ,secretary may require that such different comparable aspect of the elements to assure safe use can be used with respect to any other drug that is the subject of an application under section #eje7;j7 or #eje7;b7 that references the same listed drug4 2 and 7#d7 by adding at the end the following3 7m7 ,separate ,,rems ,when used in this section1 the terms different1 comparable aspect of the elements to assure safe use or different1 comparable approved risk evaluation and mitigation strategies means a risk evaluation and mitigation strategy for a drug that is the subject of an application under section #eje7;j7 that uses different methods or operational means than the strategy required under subsection 7a7 for the applicable listed drug1 or other application under section #eje7;j7 with the same such listed drug1 but achieves the same level of safety as such strategy4 4 #abc4 ,rule of construction 7a7 ,in general ,nothing in this subtitle1 the amendments made by this subtitle1 or in section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71 shall be construed as-- 7#a7 prohibiting a license holder from providing an eligible product developer access to a covered product in the absence of an authorization under this subtitle2 or 7#b7 in any way negating the applicability of a ,,rems with ,,etasu1 as otherwise required under such section #eje-a1 with respect to such covered product4 7b7 ,definitions ,in this section1 the terms covered product1 eligible product developer1 license holder1 and ,,rems with ,,etasu have the meanings given such terms in section #aba7;a74 ,,ii ,extension of ,public ,health ,programs #bja4 ,extension for community health centers1 the ,national ,health ,service ,corps1 and teaching health centers that operate ,,gme programs 7a7 ,community ,health ,centers ,funding ,section #ajejc7;b77#a77;,f7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #bed;b-#b7;b77#a77;,f77 is amended by striking fiscal year #bjai and inserting each of fiscal years #bjai and #bjbj4 7b7 ,national ,health ,service ,corps ,section #ajejc7;b77#b77;,f7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #bed;b-#b7;b77#b77;,f77 is amended by striking #bjah and #bjai and inserting #bjah1 #bjai1 and #bjbj4 7c7 ,teaching health centers that operate graduate medical education programs ,section #cdj;,h7g77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;h7g77#a77 is amended by striking #bjah and #bjai and inserting #bjah1 #bjai1 and #bjbj4 7d7 ,application ,amounts appropriated pursuant to this section for fiscal year #bjbj are subject to the requirements contained in ,public ,law #aae-bde for funds for programs authorized under sections #ccj through #cdj of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;b-#bef74 7e7 ,conforming amendment ,section #cjad7;h77#d7 of title #ah1 ,united ,states ,code1 is amended by striking and section #ejija7;e7 of the ,advancing ,chronic ,care1 ,extenders1 and ,social ,services ,act and inserting 1 section #ejija7;e7 of the ,advancing ,chronic ,care1 ,extenders1 and ,social ,services ,act1 and section #bja7;d7 of the ,lowering ,prescription ,drug ,costs and ,extending ,community ,health ,centers and ,other ,public ,health ,priorities ,act4 #bjb4 ,extension for special diabetes programs 7a7 ,special ,diabetes ,program for ,type ,i ,diabetes ,section #ccj;,b7b77#b77;,d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;c-#b7;b77#b77;,d77 is amended by striking #bjah and #bjai and inserting #bjah1 #bjai1 and #bjbj4 7b7 ,special ,diabetes ,program for ,indians ,section #ccj;,c7c77#b77;,d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;c-#c7;c77#b77;,d77 is amended by striking #bjah and #bjai and inserting #bjah1 #bjai1 and #bjbj4 #bjc4 ,extension for family-to-family health information centers 7a7 ,in general ,section #eja7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #gja7;c77#a77;,a77vii77 is amended by striking #bjah and #bjai and inserting #bjah1 #bjai1 and #bjbj4 7b7 ,conforming change ,section #eja7;c77#c77;,c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #gja7;c77#c77;,c77 is amended by striking #bjah and #bjai and inserting #bjah1 #bjai1 and #bjbj4 #bjd4 ,extension for sexual risk avoidance education and personal responsibility education 7a7 ,sexual risk avoidance education ,subsections 7a7 and 7f7 of section #eaj of the ,social ,security ,act 7#db ,u4,s4,c4 #gaj7 are amended by striking #bjah and #bjai each place it appears and inserting #bjah1 #bjai1 and #bjbj4 7b7 ,personal responsibility education ,section #eac of the ,social ,security ,act 7#db ,u4,s4,c4 #gac7 is amended-- 7#a7 in subsection 7a77#a77;,a71 by striking #bjai and inserting #bjbj2 and 7#b7 in subsection 7a77#d71 by striking #bjai each place it appears and inserting #bjbj2 and 7#c7 in subsection 7f71 by striking #bjai and inserting #bjbj4