116 HR 2700 IH: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act
U.S. House of Representatives
2019-05-14
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.This Act may be cited as the Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act
.
2.The table of contents of this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents. Title I—Lowering Prescription Drug Costs Subtitle A—Bringing Low-Cost Options and Competition While Keeping Incentives for New Generics Sec. 101. Change conditions of first generic exclusivity to spur access and competition. Subtitle B—Protecting Consumer Access to Generic Drugs Sec. 111. Unlawful agreements. Sec. 112. Notice and certification of agreements. Sec. 113. Forfeiture of 180-day exclusivity period. Sec. 114. Commission litigation authority. Sec. 115. Statute of limitations. Subtitle C—Creating and Restoring Equal Access to Equivalent Samples Sec. 121. Actions for delays of generic drugs and biosimilar biological products. Sec. 122. REMS approval process for subsequent filers. Sec. 123. Rule of construction. Title II—Extension of Public Health Programs Sec. 201. Extension for community health centers, the National Health Service Corps, and teaching health centers that operate GME programs. Sec. 202. Extension for special diabetes programs. Sec. 203. Extension for family-to-family health information centers. Sec. 204. Extension for sexual risk avoidance education and personal responsibility education. <enum>I</enum><header>Lowering Prescription Drug Costs</header> <subtitle id="H18DDB7542ACC47D99463735E25CB3249"><enum>A</enum><header>Bringing Low-Cost Options and Competition While Keeping Incentives for New Generics</header> <section id="H3789137E7179478F92E8D07FF82B61FC"><enum>101.</enum><header>Change conditions of first generic exclusivity to spur access and competition</header><text display-inline="no-display-inline">Section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(j)(5)(B)(iv)</external-xref>) is amended—</text>
<paragraph id="HF39EAA5DD5314635B33040F16B9CCB31"><enum>(1)</enum><text>in subclause (I), by striking <quote>180 days after</quote> and all that follows through the period at the end and inserting the following:</text> <quoted-block display-inline="yes-display-inline" id="H44FFD3BF298943C28072357409C0F446" style="OLC"> <text>180 days after the earlier of—</text><item id="HE33068BF4BBA4D2FB098D2013BEDB947" indent="up1"><enum>(aa)</enum><text display-inline="yes-display-inline">the date of the first commercial marketing of the drug (including the commercial marketing of the listed drug) by any first applicant; or</text>
</item><item id="HF1BBAD43B1D44F07A4EDFA6645710768" indent="up1"><enum>(bb)</enum><text>the applicable date specified in subclause (III).</text></item><after-quoted-block>; and</after-quoted-block></quoted-block> </paragraph><paragraph id="HBA7706A275EA4C1FB5E3764408D47CEE"><enum>(2)</enum><text>by adding at the end the following new subclause:</text>
<quoted-block display-inline="no-display-inline" id="HF663E5EF99A845F48C9F41E4C9F88374" style="OLC">
<subclause id="H67A2A4DB18BA4B1DB818BCFE106AADFA" indent="up1"><enum>(III)</enum><header>Applicable date</header><text display-inline="yes-display-inline">The applicable date specified in this subclause, with respect to an application for a drug described in subclause (I), is the date on which each of the following conditions is first met:</text>
<item id="H2B66BC49562945F19A1A2BA4115C8F33"><enum>(aa)</enum><text display-inline="yes-display-inline">The approval of such an application could be made effective, but for the eligibility of a first applicant for 180-day exclusivity under this clause.<italic></italic></text>
</item><item id="H3443F0B66CA24BC2B5BE57DFDF5C43F8"><enum>(bb)</enum><text display-inline="yes-display-inline">At least 30 months have passed since the date of submission of an application for the drug by at least one first applicant.</text>
</item><item id="HA2575DAC3CFE403BB0C749E4B4CA651F"><enum>(cc)</enum><text display-inline="yes-display-inline">Approval of an application for the drug submitted by at least one first applicant is not precluded under clause (iii)<italic></italic>.</text>
</item><item id="H5F9DFCBC13C949F7B7654F616D594EC8"><enum>(dd)</enum><text>No application for the drug submitted by any first applicant is approved at the time the conditions under items (aa), (bb), and (cc) are all met, regardless of whether such an application is subsequently approved.</text></item></subclause><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section></subtitle><subtitle id="H7F1A460985394085A71ECC023A6EFF26"><enum>B</enum><header>Protecting Consumer Access to Generic Drugs</header>
<section id="HB446C1B5B58D4E9788C2A46750479B32"><enum>111.</enum><header>Unlawful agreements</header>
<subsection id="H572D0C8854694707B5A7FF9832E8429F"><enum>(a)</enum><header>Agreements prohibited</header><text display-inline="yes-display-inline">Subject to subsections (b) and (c), it shall be unlawful for an NDA or BLA holder and a subsequent filer (or for two subsequent filers) to enter into, or carry out, an agreement resolving or settling a covered patent infringement claim on a final or interim basis if under such agreement—</text>
<paragraph id="HB3AC23FECA294E828341B081711AB390"><enum>(1)</enum><text display-inline="yes-display-inline">a subsequent filer directly or indirectly receives from such holder (or in the case of such an agreement between two subsequent filers, the other subsequent filer) anything of value, including a license; and</text>
</paragraph><paragraph id="HE12B1075EB7747C581BB0B4D495AEBCD"><enum>(2)</enum><text>the subsequent filer agrees to limit or forego research on, or development, manufacturing, marketing, or sales, for any period of time, of the covered product that is the subject of the application described in subparagraph (A) or (B) of subsection (g)(8).</text>
</paragraph></subsection><subsection id="H36DEE59516A840B5906540F25C778E3E"><enum>(b)</enum><header>Exclusion</header><text display-inline="yes-display-inline">It shall not be unlawful under subsection (a) if a party to an agreement described in such subsection demonstrates by clear and convincing evidence that the value described in subsection (a)(1) is compensation solely for other goods or services that the subsequent filer has promised to provide.</text>
</subsection><subsection id="H690E7C3A22C647DCB285055A5A8228BD"><enum>(c)</enum><header>Limitation</header><text display-inline="yes-display-inline">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 (or from one subsequent filer to another) as part of the resolution or settlement includes only one or more of the following:</text>
<paragraph id="HB6D0399F291D49C6A9338478516E39CC"><enum>(1)</enum><text display-inline="yes-display-inline">The right to market the covered product that is the subject of the application described in subparagraph (A) or (B) of subsection (g)(8) in the United States before the expiration of—</text>
<subparagraph id="HD33448965F4548ADB392D56C6729DE82"><enum>(A)</enum><text>any patent that is the basis of the covered patent infringement claim; or</text> </subparagraph><subparagraph id="HDC804D3AADDC4C94A883DE0779E4D8D2"><enum>(B)</enum><text display-inline="yes-display-inline">any patent right or other statutory exclusivity that would prevent the marketing of such covered product.</text>
</subparagraph></paragraph><paragraph id="H9B802AD48DB4452CB100632BCBC40E0E"><enum>(2)</enum><text>A payment for reasonable litigation expenses not to exceed $7,500,000 in the aggregate.</text> </paragraph><paragraph id="HD7A1FBC66DC04AD4B101356F5299AA02"><enum>(3)</enum><text>A covenant not to sue on any claim that such covered product infringes a patent.</text>
</paragraph></subsection><subsection display-inline="no-display-inline" id="H4DAEF07051E8429CAF3940BB16059753"><enum>(d)</enum><header>Enforcement by Federal Trade Commission</header>
<paragraph id="H853AB072271A46C68BE167B60EA7C6A1"><enum>(1)</enum><header>General application</header><text display-inline="yes-display-inline">The requirements of this section apply, according to their terms, to an NDA or BLA holder or subsequent filer that is—</text>
<subparagraph id="H88CE3598F24B46CA90BFCFC7E70C2E12"><enum>(A)</enum><text display-inline="yes-display-inline">a person, partnership, or corporation over which the Commission has authority pursuant to section 5(a)(2) of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/45">15 U.S.C. 45(a)(2)</external-xref>); or</text>
</subparagraph><subparagraph id="HBE8295FBBA194C93BF70F188A4C3D007"><enum>(B)</enum><text display-inline="yes-display-inline">a person, partnership, or corporation over which the Commission would have authority pursuant to such section but for the fact that such person, partnership, or corporation is not organized to carry on business for its own profit or that of its members.</text>
</subparagraph></paragraph><paragraph id="H3CF09F85DA0C425C9E10DF5C481213CC"><enum>(2)</enum><header>Unfair or deceptive acts or practices enforcement authority</header>
<subparagraph id="H4221B14F7060480492E975082243B771"><enum>(A)</enum><header>In general</header><text>A violation of this section shall be treated as an unfair or deceptive act or practice in violation of section 5(a)(1) of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/45">15 U.S.C. 45(a)(1)</external-xref>).</text>
</subparagraph><subparagraph id="H322E9D3F9CB74F45B9DB8C7F4902E5E3"><enum>(B)</enum><header>Powers of Commission</header><text display-inline="yes-display-inline">Except as provided in subparagraph (C) and paragraphs (1)(B) and (3)—</text> <clause id="HA46003654E5F44E6B1111C8C69AD68E6"><enum>(i)</enum><text display-inline="yes-display-inline">the Commission shall enforce this section in the same manner, by the same means, and with the same jurisdiction, powers, and duties as though all applicable terms and provisions of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/41">15 U.S.C. 41</external-xref> et seq.) were incorporated into and made a part of this section; and</text>
</clause><clause id="H35FBE33D198B4D92BED7841F4EF43030"><enum>(ii)</enum><text display-inline="yes-display-inline">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 Act.</text>
</clause></subparagraph><subparagraph id="H49F8F3F5129B4C87ADDA5164F9AA611D"><enum>(C)</enum><header>Judicial review</header><text display-inline="yes-display-inline">In the case of a cease and desist order issued by the Commission under section 5 of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/45">15 U.S.C. 45</external-xref>) for violation of this section, a party to such order may obtain judicial review of such order as provided in such section 5, except that—</text>
<clause id="HCDDE863B2DE0439F8AC491AF662BA381"><enum>(i)</enum><text>such review may only be obtained in—</text> <subclause id="HE8A4242AF2FF48A59C55D275242663C3"><enum>(I)</enum><text>the United States Court of Appeals for the District of Columbia Circuit;</text>
</subclause><subclause id="HAC11BCE2AFC44C46825997E142997505"><enum>(II)</enum><text display-inline="yes-display-inline">the United States Court of Appeals for the circuit in which the ultimate parent entity, as defined in section 801.1(a)(3) of title 16, Code of Federal Regulations, or any successor thereto, of the NDA or BLA holder (if any such holder is a party to such order) is incorporated as of the date that the application described in subparagraph (A) or (B) of subsection (g)(8) or an approved application that is deemed to be a license for a biological product under section 351(k) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(k)</external-xref>) pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 (<external-xref legal-doc="public-law" parsable-cite="pl/111/148">Public Law 111–148</external-xref>; 124 Stat. 817) is submitted to the Commissioner of Food and Drugs; or</text>
</subclause><subclause id="HB97B4429FB3D4433A092A46D743CF60B"><enum>(III)</enum><text display-inline="yes-display-inline">the United States Court of Appeals for the circuit in which the ultimate parent entity, as so defined, of any subsequent filer that is a party to such order is incorporated as of the date that the application described in subparagraph (A) or (B) of subsection (g)(8) is submitted to the Commissioner of Food and Drugs; and</text>
</subclause></clause><clause commented="no" id="HDD373ADCBE6D404C967DCABFD62612A0"><enum>(ii)</enum><text>the petition for review shall be filed in the court not later than 30 days after such order is served on the party seeking review.</text>
</clause></subparagraph></paragraph><paragraph id="HD07793F9F20E45A08D4BFE931BB6A0BE"><enum>(3)</enum><header>Additional enforcement authority</header>
<subparagraph id="HAF7AE644DA3148A1BABF46E90959A3F7"><enum>(A)</enum><header>Civil penalty</header><text display-inline="yes-display-inline">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 section.</text>
</subparagraph><subparagraph id="HEBE2C9EB639F4663A74A55C1BB8DBAA4"><enum>(B)</enum><header>Special rule for recovery of penalty if cease and desist order issued</header>
<clause id="HD391BF0B5C744327B5D2449FF03FCA43"><enum>(i)</enum><header>In general</header><text>If the Commission has issued a cease and desist order in a proceeding under section 5 of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/45">15 U.S.C. 45</external-xref>) for violation of this section—</text>
<subclause id="H5DC032C9AFD94215BB42EE050EB65E2E"><enum>(I)</enum><text>the Commission may commence a civil action under subparagraph (A) to recover a civil penalty against any party to such order at any time before the expiration of the 1-year period beginning on the date on which such order becomes final under section 5(g) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/15/45">15 U.S.C. 45(g)</external-xref>); and</text>
</subclause><subclause id="H6426042FC1824FB89485586F6355F74D"><enum>(II)</enum><text>in such civil action, the findings of the Commission as to the material facts in such proceeding shall be conclusive, unless—</text>
<item commented="no" id="H5FF9C4068BE1441485810E3304B96B59"><enum>(aa)</enum><text>the terms of such order expressly provide that the Commission’s findings shall not be conclusive; or</text>
</item><item commented="no" id="H28629956587E4068AF6231A703C09176"><enum>(bb)</enum><text>such order became final by reason of section 5(g)(1) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/15/45">15 U.S.C. 45(g)(1)</external-xref>), in which case such findings shall be conclusive if supported by evidence.</text>
</item></subclause></clause><clause id="HB3D34B3E5FA54DB092669DF19E3ED852"><enum>(ii)</enum><header>Relationship to penalty for violation of an order</header><text display-inline="yes-display-inline">The penalty provided in clause (i) 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 5(l) of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/45">15 U.S.C. 45(l)</external-xref>).</text>
</clause></subparagraph><subparagraph id="H78A12B12E36643BF8E277CC19AE91BE3"><enum>(C)</enum><header>Amount of penalty</header>
<clause commented="no" id="HA5169C7F40044C549C76D88EF1680D0D"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">The amount of a civil penalty imposed in a civil action under subparagraph (A) on a party to an agreement described in subsection (a) shall be sufficient to deter violations of this section, but in no event greater than—</text>
<subclause id="HADAA652255AC4D9F8BFC98846B042C11"><enum>(I)</enum><text display-inline="yes-display-inline">if such party is the NDA or BLA holder (or, in the case of an agreement between two subsequent filers, the subsequent filer who gave the value described in subsection (a)(1)), the greater of—</text>
<item id="HD3C80BA6CA84462680BCBB7DD57FA6A0"><enum>(aa)</enum><text display-inline="yes-display-inline">3 times the value received by such NDA or BLA holder (or by such subsequent filer) that is reasonably attributable to the violation of this section; or</text>
</item><item id="H559EEE6A91D9485685BB5146747C1E89"><enum>(bb)</enum><text display-inline="yes-display-inline">3 times the value given to the subsequent filer (or to the other subsequent filer) reasonably attributable to the violation of this section; and</text>
</item></subclause><subclause id="H97203181A5EB45569EA51CFD5F52D9FF"><enum>(II)</enum><text display-inline="yes-display-inline">if such party is the subsequent filer (or, in the case of an agreement between two subsequent filers, the subsequent filer who received the value described in subsection (a)(1)), 3 times the value received by such subsequent filer that is reasonably attributable to the violation of this section.</text>
</subclause></clause><clause id="HC7681A80753A43D992D7F497152FA195"><enum>(ii)</enum><header>Factors for consideration</header><text>In determining such amount, the court shall take into account—</text> <subclause id="H6DE0B23E528F4D1D996AD92AAC9A1678"><enum>(I)</enum><text>the nature, circumstances, extent, and gravity of the violation;</text>
</subclause><subclause id="HD91FD831EAAD42498F12CDCF14452D77"><enum>(II)</enum><text display-inline="yes-display-inline">with respect to the violator, the degree of culpability, any history of violations, the ability to pay, any effect on the ability to continue doing business, profits earned by the NDA or BLA holder (or, in the case of an agreement between two subsequent filers, the subsequent filer who gave the value described in subsection (a)(1)), compensation received by the subsequent filer (or, in the case of an agreement between two subsequent filers, the subsequent filer who received the value described in subsection (a)(1)), and the amount of commerce affected; and</text>
</subclause><subclause id="H6E06F58DBF65461285CB0C11148D9766"><enum>(III)</enum><text>other matters that justice requires.</text> </subclause></clause></subparagraph><subparagraph id="H650B886EBDA14C5B8F178F71F95446E5"><enum>(D)</enum><header>Injunctions and other equitable relief</header><text display-inline="yes-display-inline">In a civil action under subparagraph (A), the United States district courts are empowered to grant mandatory injunctions and such other and further equitable relief as they deem appropriate.</text>
</subparagraph></paragraph><paragraph id="HB9F4C3F7793C4E3793EBD22D0FC7FE6C"><enum>(4)</enum><header>Remedies in addition</header><text>Remedies provided in this subsection are in addition to, and not in lieu of, any other remedy provided by Federal law.</text>
</paragraph><paragraph id="H4466F644F76341419B34467FB598530A"><enum>(5)</enum><header>Preservation of authority of Commission</header><text>Nothing in this section shall be construed to affect any authority of the Commission under any other provision of law.</text>
</paragraph></subsection><subsection id="H1E5D90B18FFB4903818F1B3813FC6A83"><enum>(e)</enum><header>Federal Trade Commission rulemaking</header><text display-inline="yes-display-inline">The Commission may, in its discretion, by rule promulgated under section 553 of title 5, United States Code, exempt from this section certain agreements described in subsection (a) if the Commission finds such agreements to be in furtherance of market competition and for the benefit of consumers.</text>
</subsection><subsection display-inline="no-display-inline" id="HED7F2BDDCA9A400CBE3C1F9CE948F08E"><enum>(f)</enum><header>Antitrust laws</header><text display-inline="yes-display-inline">Nothing in this section shall modify, impair, limit, or supersede the applicability of the antitrust laws as defined in subsection (a) of the first section of the Clayton Act (<external-xref legal-doc="usc" parsable-cite="usc/15/12">15 U.S.C. 12(a)</external-xref>), and of section 5 of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/45">15 U.S.C. 45</external-xref>) to the extent that such section 5 applies to unfair methods of competition. Nothing in this section shall modify, impair, limit, or supersede the right of a subsequent filer to assert claims or counterclaims against any person, under the antitrust laws or other laws relating to unfair competition.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H8CB602C750F64B7999B21C8B05CB9D8C"><enum>(g)</enum><header>Definitions</header><text>In this section:</text> <paragraph commented="no" id="H081458F30ED8408B94B200C2977BBBF0"><enum>(1)</enum><header>Agreement resolving or settling a covered patent infringement claim</header><text display-inline="yes-display-inline">The term <term>agreement resolving or settling a covered patent infringement claim</term> means any agreement that—</text>
<subparagraph id="H90C4BD017DD948C9AA70875D311815D6"><enum>(A)</enum><text>resolves or settles a covered patent infringement claim; or</text> </subparagraph><subparagraph id="HF872FBBFCF024F7D846E639FBB604293"><enum>(B)</enum><text>is contingent upon, provides for a contingent condition for, or is otherwise related to the resolution or settlement of a covered patent infringement claim.</text>
</subparagraph></paragraph><paragraph id="H80CA5E958D044E4EB6B5CFC9A7056187"><enum>(2)</enum><header>Commission</header><text>The term <term>Commission</term> means the Federal Trade Commission.</text> </paragraph><paragraph commented="no" id="HAEFC3C72B4664F4FA52035E9EC5A19B1"><enum>(3)</enum><header>Covered patent infringement claim</header><text display-inline="yes-display-inline">The term <term>covered patent infringement claim</term> means an allegation made by the NDA or BLA holder to a subsequent filer (or, in the case of an agreement between two subsequent filers, by one subsequent filer to another), whether or not included in a complaint filed with a court of law, that—</text>
<subparagraph commented="no" id="H684C5592CFDF4540BA50350B361E25BF"><enum>(A)</enum><text display-inline="yes-display-inline">the submission of the application described in subparagraph (A) or (B) of paragraph (9), or the manufacture, use, offering for sale, sale, or importation into the United States of a covered product that is the subject of such an application—</text>
<clause id="H2BEEF17D7B834536922B632F0428E185"><enum>(i)</enum><text display-inline="yes-display-inline">in the case of an agreement between an NDA or BLA holder and a subsequent filer, infringes any patent owned by, or exclusively licensed to, the NDA or BLA holder of the covered product; or</text>
</clause><clause id="HC0EEBD91431F413984E44860DCEE719D"><enum>(ii)</enum><text>in the case of an agreement between two subsequent filers, infringes any patent owned by the subsequent filer; or</text>
</clause></subparagraph><subparagraph commented="no" id="H685FAA376698404FB5B0285B16C5C32E"><enum>(B)</enum><text display-inline="yes-display-inline">in the case of an agreement between an NDA or BLA holder and a subsequent filer, the covered product to be manufactured under such application uses a covered product as claimed in a published patent application.</text>
</subparagraph></paragraph><paragraph commented="no" id="H0584C6A357E6411491134891599E9974"><enum>(4)</enum><header>Covered product</header><text display-inline="yes-display-inline">The term <term>covered product</term> means a drug (as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321(g)</external-xref>)), including a biological product (as defined in section 351(i) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(i)</external-xref>).</text>
</paragraph><paragraph commented="no" id="HD7BA676A438D48D4B5419586F2C53F68"><enum>(5)</enum><header>NDA or BLA holder</header><text>The term <term>NDA or BLA holder</term> means—</text> <subparagraph commented="no" id="HAEB687F186FF4F9EB3298FAD88C27312"><enum>(A)</enum><text display-inline="yes-display-inline">the holder of—</text>
<clause id="HF9CEEF9D6C174501857A927416A776D4"><enum>(i)</enum><text display-inline="yes-display-inline">an approved new drug application filed under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(b)(1)</external-xref>) for a covered product; or</text>
</clause><clause id="HCD8005FB3A16449091510AEB161434CA"><enum>(ii)</enum><text display-inline="yes-display-inline">a biologics license application filed under section 351(a) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(a)</external-xref>) with respect to a biological product;</text>
</clause></subparagraph><subparagraph commented="no" id="HC544FEB35B7942FA8E80E6B7FB10CE69"><enum>(B)</enum><text display-inline="yes-display-inline">a person owning or controlling enforcement of the patent on—</text> <clause id="H490C50A415074F37B170A4229BF9041E"><enum>(i)</enum><text>the list published under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(j)(7)</external-xref>) in connection with the application described in subparagraph (A)(i); or</text>
</clause><clause id="HD2CE1E8598C448298FBA7764C5A93515"><enum>(ii)</enum><text display-inline="yes-display-inline">any list published under section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>) comprised of patents associated with biologics license applications filed under section 351(a) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(a)</external-xref>); or</text>
</clause></subparagraph><subparagraph commented="no" id="HCF0665F8422046399A7923589FA29212"><enum>(C)</enum><text>the predecessors, subsidiaries, divisions, groups, and affiliates controlled by, controlling, or under common control with any entity described in subparagraph (A) or (B) (such control to be presumed by direct or indirect share ownership of 50 percent or greater), as well as the licensees, licensors, successors, and assigns of each of the entities.</text>
</subparagraph></paragraph><paragraph id="HE479D42CA97D4961B936F9651692343D"><enum>(6)</enum><header>Patent</header><text>The term <term>patent</term> means a patent issued by the United States Patent and Trademark Office.</text> </paragraph><paragraph commented="no" id="H0D445DD7B722447C8624CEB422B4C606"><enum>(7)</enum><header>Statutory exclusivity</header><text display-inline="yes-display-inline">The term <term>statutory exclusivity</term> means those prohibitions on the submission or approval of drug applications under clauses (ii) through (iv) of section 505(c)(3)(E) (5- and 3-year exclusivity), clauses (ii) through (iv) of section 505(j)(5)(F) (5-year and 3-year exclusivity), section 505(j)(5)(B)(iv) (180-day exclusivity), section 527 (orphan drug exclusivity), section 505A (pediatric exclusivity), or section 505E (qualified infectious disease product exclusivity) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(c)(3)(E)</external-xref>, 355(j)(5)(B)(iv), 355(j)(5)(F), 360cc, 355a, 355f), or prohibitions on the submission or licensing of biologics license applications under section 351(k)(6) (interchangeable biological product exclusivity) or section 351(k)(7) (biological product reference product exclusivity) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(k)(6)</external-xref>, (7)).</text>
</paragraph><paragraph commented="no" id="H07CD85DDD3DC47A0BCD56ABB125080DD"><enum>(8)</enum><header>Subsequent filer</header><text>The term <term>subsequent filer</term> means—</text> <subparagraph id="H839C5132313749AB8E438AC6EBC8B168"><enum>(A)</enum><text display-inline="yes-display-inline">in the case of a drug, a party that owns or controls an abbreviated new drug application submitted pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(j)</external-xref>) or a new drug application submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (21U.S.C. 355(b)(2)) and filed under section 505(b)(1) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(b)(1)</external-xref>) or has the exclusive rights to distribute the covered product that is the subject of such application; or</text>
</subparagraph><subparagraph id="H60DE6FCE7336455F88851D392C4BD721"><enum>(B)</enum><text display-inline="yes-display-inline">in the case of a biological product, a party that owns or controls an application filed with the Food and Drug Administration under section 351(k) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(k)</external-xref>) or has the exclusive rights to distribute the biological product that is the subject of such application.</text>
</subparagraph></paragraph></subsection><subsection id="H3E090645D37443309147B8E33E384D69"><enum>(h)</enum><header>Effective date</header><text display-inline="yes-display-inline">This section applies with respect to agreements described in subsection (a) entered into on or after the date of the enactment of this Act.</text>
</subsection></section><section display-inline="no-display-inline" id="HC08701DF32C0428FA857C8CA5F70A93B"><enum>112.</enum><header>Notice and certification of agreements</header>
<subsection id="H87A8210D34C44766A4A2240C900B84DD"><enum>(a)</enum><header>Notice of all agreements</header><text display-inline="yes-display-inline">Section 1111(7) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref> note) is amended by inserting <quote>or the owner of a patent for which a claim of infringement could reasonably be asserted against any person for making, using, offering to sell, selling, or importing into the United States a biological product that is the subject of a biosimilar biological product application</quote> before the period at the end.</text>
</subsection><subsection id="H02A29DC6AB284028875250B2F950FA4F"><enum>(b)</enum><header>Certification of agreements</header><text>Section 1112 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref> note) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H8485EFA9094B46AF884B14AD127EF75E" style="OLC"> <subsection id="H4CAA22EED58E45758F4FB34AFB099C57"><enum>(d)</enum><header>Certification</header><text>The Chief Executive Officer or the company official responsible for negotiating any agreement under subsection (a) or (b) that is required to be filed under subsection (c) shall, within 30 days of such filing, execute and file with the Assistant Attorney General and the Commission a certification as follows:</text>
<quoted-block display-inline="yes-display-inline" id="H15FCFEA232944D5E83FA63196BFC500A" style="OLC">
<text>I declare that the following is true, correct, and complete to the best of my knowledge: The materials filed with the Federal Trade Commission and the Department of Justice under section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, with respect to the agreement referenced in this certification—</text><paragraph id="HC4171A3E2C4F4D7691249E9BBA9F6F90"><enum>(1)</enum><text>represent the complete, final, and exclusive agreement between the parties;</text> </paragraph><paragraph id="H2FB484EF65A343FAB65CE018BF8CBF11"><enum>(2)</enum><text display-inline="yes-display-inline">include any ancillary agreements that are contingent upon, provide a contingent condition for, were entered into within 30 days of, or are otherwise related to, the referenced agreement; and</text>
</paragraph><paragraph id="H3CCAFD93CCDC400B853003BCAE2FDDD4"><enum>(3)</enum><text>include written descriptions of any oral agreements, representations, commitments, or promises between the parties that are responsive to subsection (a) or (b) of such section 1112 and have not been reduced to writing.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section id="H8BC8F68185D042EE9ABB2D9D4F3F3B5E"><enum>113.</enum><header>Forfeiture of 180-day exclusivity period</header><text display-inline="no-display-inline">Section 505(j)(5)(D)(i)(V) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(j)(5)(D)(i)(V)</external-xref>) is amended by inserting <quote>section 111 of the <short-title>Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act</short-title> or</quote> after <quote>that the agreement has violated</quote>.</text>
</section><section id="H58E93E3E0ACF4A2DAF61516E849C4BAC"><enum>114.</enum><header>Commission litigation authority</header><text display-inline="no-display-inline">Section 16(a)(2) of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/56">15 U.S.C. 56(a)(2)</external-xref>) is amended—</text> <paragraph id="H8B2FCD33CDA94E818007B32B495B9D87"><enum>(1)</enum><text>in subparagraph (D), by striking <quote>or</quote> after the semicolon;</text>
</paragraph><paragraph id="H581F0392D3404076987C6BBEC447887F"><enum>(2)</enum><text>in subparagraph (E), by inserting <quote>or</quote> after the semicolon; and</text> </paragraph><paragraph id="HFFEA9514A24940B58E8C66F211D1EA86"><enum>(3)</enum><text>by inserting after subparagraph (E) the following:</text>
<quoted-block display-inline="no-display-inline" id="HA4B028F4307A4BB8B4BC1AD17779958F" style="OLC">
<subparagraph commented="no" id="H636D000C85AB4F3FA32C8B9CB03E61BF"><enum>(F)</enum><text display-inline="yes-display-inline">under section 111(d)(3)(A) of the <short-title>Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act</short-title>;</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section id="H43596F6893964AC69EDA3420D3B7BA35"><enum>115.</enum><header>Statute of limitations</header>
<subsection id="H74E3F586556C4807A4C7A270AD5D9C85"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Except as provided in subsection (b), the Commission shall commence any administrative proceeding or civil action to enforce section 111 of this Act not later than 6 years after the date on which the parties to the agreement file the Notice of Agreement as provided by section 1112(c)(2) and (d) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref> note).</text>
</subsection><subsection id="HF68BB6B8DD1A470DBD5EC59468190162"><enum>(b)</enum><header>Civil action after issuance of cease and desist order</header><text>If the Commission has issued a cease and desist order under section 5 of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/45">15 U.S.C. 45</external-xref>) for violation of section 111 of this Act and the proceeding for the issuance of such order was commenced within the period required by subsection (a) of this section, such subsection does not prohibit the commencement, after such period, of a civil action under section 111(d)(3)(A) against a party to such order or a civil action under subsection (l) of such section 5 for violation of such order.</text>
</subsection></section></subtitle><subtitle id="HCE6F3D96BFF84119AC7DDCFE21379394"><enum>C</enum><header>Creating and Restoring Equal Access to Equivalent Samples</header>
<section id="HAC1041782B084A6CA3A40D9753AE0582"><enum>121.</enum><header>Actions for delays of generic drugs and biosimilar biological products</header>
<subsection id="H2862C38FFE514A97A07359BF193164BF"><enum>(a)</enum><header>Definitions</header><text>In this section—</text> <paragraph id="H9A2D46C9F79844EF915010CB1B8D2CE0"><enum>(1)</enum><text>the term <term>commercially reasonable, market-based terms</term> means—</text>
<subparagraph id="H32177578B80543A5BEDFFC3327AC4FCF"><enum>(A)</enum><text>a nondiscriminatory price for the sale of the covered product at or below, but not greater than, the most recent wholesale acquisition cost for the drug, as defined in section 1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w–3a(c)(6)(B));</text>
</subparagraph><subparagraph id="HF200CCE4108E4C758538DA1922854A31"><enum>(B)</enum><text>a schedule for delivery that results in the transfer of the covered product to the eligible product developer consistent with the timing under subsection (b)(2)(A)(iv); and</text>
</subparagraph><subparagraph id="HA31CF275837947FBA7879FC01B4E7D67"><enum>(C)</enum><text>no additional conditions are imposed on the sale of the covered product;</text> </subparagraph></paragraph><paragraph id="H35E5B4AC1686454DBCFA4C1E123DE670"><enum>(2)</enum><text>the term <term>covered product</term>—</text>
<subparagraph id="HE1A783E5BEBD430D8008D20A0912EA5A"><enum>(A)</enum><text>means—</text> <clause id="H9F1FC961BA7E466D922CD7A1AD7F4470"><enum>(i)</enum><text>any drug approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>) or biological product licensed under subsection (a) or (k) of section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>);</text>
</clause><clause id="H05A33DC365FF467DA59FECF542803851"><enum>(ii)</enum><text>any combination of a drug or biological product described in clause (i); or</text> </clause><clause id="H71779DC793FB43B4B36E3DA050360EEA"><enum>(iii)</enum><text>when reasonably necessary to support approval of an application under section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>), or section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>), as applicable, or otherwise meet the requirements for approval under either such section, any product, including any device, that is marketed or intended for use with such a drug or biological product; and</text>
</clause></subparagraph><subparagraph id="HEBE50253A7654F42937519C5C4843A25"><enum>(B)</enum><text display-inline="yes-display-inline">does not include any drug or biological product that appears on the drug shortage list in effect under section 506E of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/356e">21 U.S.C. 356e</external-xref>), unless—</text>
<clause id="H4348D69B1A8F4070B10601203E07B59C"><enum>(i)</enum><text display-inline="yes-display-inline">the drug or biological product has been on the drug shortage list in effect under such section 506E continuously for more than 6 months; or</text>
</clause><clause id="HF4546D2E694B4D07AE527A97DD45A1B2"><enum>(ii)</enum><text display-inline="yes-display-inline">the Secretary determines that inclusion of the drug or biological product as a covered product is likely to contribute to alleviating or preventing a shortage.</text>
</clause></subparagraph></paragraph><paragraph id="H3C29061A1D70472A84A0969D6C06A54E"><enum>(3)</enum><text>the term <term>device</term> has the meaning given the term in section 201 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321</external-xref>);</text>
</paragraph><paragraph id="H96D7388ABC38453C987B37141AE58EE6"><enum>(4)</enum><text>the term <term>eligible product developer</term> means a person that seeks to develop a product for approval pursuant to an application for approval under subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>) or for licensing pursuant to an application under section 351(k) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(k)</external-xref>);</text>
</paragraph><paragraph id="H054D7FEAE3C648B19732BEFFCFDC6DC5"><enum>(5)</enum><text>the term <term>license holder</term> means the holder of an application approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>) or the holder of a license under subsection (a) or (k) of section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>) for a covered product;</text>
</paragraph><paragraph id="HA08B32C5B49B4A4AA887086B4AB70C56"><enum>(6)</enum><text>the term <term>REMS</term> means a risk evaluation and mitigation strategy under section 505–1 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355-1">21 U.S.C. 355–1</external-xref>);</text>
</paragraph><paragraph id="HC050FF21A0094B5FA5D02D54852615C3"><enum>(7)</enum><text>the term <term>REMS with ETASU</term> means a REMS that contains elements to assure safe use under section 505–1(f) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355-1">21 U.S.C. 355–1(f)</external-xref>);</text>
</paragraph><paragraph id="H64340E6083EA44C3AD201650E50D3615"><enum>(8)</enum><text>the term <term>Secretary</term> means the Secretary of Health and Human Services;</text> </paragraph><paragraph id="H35115BBB933C49C486B2B2C317818EAF"><enum>(9)</enum><text>the term <term>single, shared system of elements to assure safe use</term> means a single, shared system of elements to assure safe use under section 505–1(f) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355-1">21 U.S.C. 355–1(f)</external-xref>); and</text>
</paragraph><paragraph id="HBF2378F454214AE19DB61EB3ACD7901D"><enum>(10)</enum><text display-inline="yes-display-inline">the term <term>sufficient quantities</term> means an amount of a covered product that the eligible product developer determines allows it to—</text> <subparagraph id="H49C3DD87CC4245E3AF2F1534FBD13130"><enum>(A)</enum><text>conduct testing to support an application under—</text>
<clause id="HFF1BFDB13CF54126AD06D808E31855B1"><enum>(i)</enum><text>subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>); or</text>
</clause><clause id="H2BF3534075D248CBA5352EE02419973C"><enum>(ii)</enum><text>section 351(k) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(k)</external-xref>); and</text> </clause></subparagraph><subparagraph id="HDAEAE7841D5E4B998BAE26EFE4753883"><enum>(B)</enum><text>fulfill any regulatory requirements relating to approval of such an application.</text>
</subparagraph></paragraph></subsection><subsection id="HFD8E320AD5F54F31AB4A99EDD4CF64D4"><enum>(b)</enum><header>Civil action for failure To provide sufficient quantities of a covered product</header>
<paragraph id="H1FD04B09D3CB43A5AF18BFE424EBFF81"><enum>(1)</enum><header>In general</header><text>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 reasonable, market-based terms.</text>
</paragraph><paragraph id="H2466D001E7A04C4AA44725E2016DD79C"><enum>(2)</enum><header>Elements</header>
<subparagraph id="H5E174B9E493546BAAFA079C6C5F59D4A"><enum>(A)</enum><header>In general</header><text>To prevail in a civil action brought under paragraph (1), an eligible product developer shall prove, by a preponderance of the evidence—</text>
<clause id="HB3DDD8763B6C4C038664B9F10CA8B86C"><enum>(i)</enum><text>that—</text> <subclause id="HB61318605D2C4BE58D5AEC369460C16A"><enum>(I)</enum><text>the covered product is not subject to a REMS with ETASU; or</text>
</subclause><subclause id="H67DEF4A8954246CBA9AA6DD8E19BE013"><enum>(II)</enum><text>if the covered product is subject to a REMS with ETASU—</text> <item id="H580FF6FB7BFD4E01A7DDD53FBDC2174D"><enum>(aa)</enum><text>the eligible product developer has obtained a covered product authorization from the Secretary in accordance with subparagraph (B); and</text>
</item><item id="H8977DA2FC3004188896241AFA6CE348B"><enum>(bb)</enum><text>the eligible product developer has provided a copy of the covered product authorization to the license holder;</text>
</item></subclause></clause><clause id="HA9F9E749BCEB4E2C8B70C11BBBA07279"><enum>(ii)</enum><text>that, as of the date on which the civil action is filed, the product developer has not obtained sufficient quantities of the covered product on commercially reasonable, market-based terms;</text>
</clause><clause commented="no" id="H6ED37D6CF66A41C18F6253A252A2BF73"><enum>(iii)</enum><text>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—</text>
<subclause id="H91874CBC44F44CE7A50704DE0727CE74"><enum>(I)</enum><text>was sent to a named corporate officer of the license holder;</text> </subclause><subclause commented="no" id="HE53EAF2E2F3A4190928D048F89B390FC"><enum>(II)</enum><text>was made by certified or registered mail with return receipt requested;</text>
</subclause><subclause commented="no" id="H1F45E0894EC64B928A0625D738E46DB6"><enum>(III)</enum><text>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 individual; and</text>
</subclause><subclause commented="no" id="HD4DA6257E95E447D98CC276CD772358B"><enum>(IV)</enum><text>specified an address to which the covered product was to be shipped upon reaching an agreement to transfer the covered product; and</text>
</subclause></clause><clause id="H804EE25A00D147EF8A41BC8A3AC6D6DA"><enum>(iv)</enum><text>that the license holder has not delivered to the eligible product developer sufficient quantities of the covered product on commercially reasonable, market-based terms—</text>
<subclause id="H189EAC25E5954DB196FB401A28994750"><enum>(I)</enum><text>for a covered product that is not subject to a REMS with ETASU, by the date that is 31 days after the date on which the license holder received the request for the covered product; and</text>
</subclause><subclause id="H19AE7438A87842F59CB5FEEA79269394"><enum>(II)</enum><text>for a covered product that is subject to a REMS with ETASU, by 31 days after the later of—</text> <item id="H0E7F8F8AFB6A44BA902BD58DCD3C6003"><enum>(aa)</enum><text>the date on which the license holder received the request for the covered product; or</text>
</item><item id="H34B479E79BDA4047966D210D95407540"><enum>(bb)</enum><text>the date on which the license holder received a copy of the covered product authorization issued by the Secretary in accordance with subparagraph (B).</text>
</item></subclause></clause></subparagraph><subparagraph id="HDDAB9223358142C2B9497562C240ED8A"><enum>(B)</enum><header>Authorization for covered product subject to a REMS with ETASU</header>
<clause id="HF93D5F88A0BF4AAC9FD1D0BF340F1994"><enum>(i)</enum><header>Request</header><text>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 ETASU.</text>
</clause><clause id="H9B3E3A027C1C40E5BE9F3955DE6CA38E"><enum>(ii)</enum><header>Authorization</header><text>Not later than 120 days after the date on which a request under clause (i) is received, the Secretary shall, by written notice, authorize the eligible product developer to obtain sufficient quantities of an individual covered product subject to a REMS with ETASU for purposes of—</text>
<subclause id="H0C2BF6C3BEF3458493389F27B4C02C67"><enum>(I)</enum><text>development and testing that does not involve human clinical trials, if the eligible product developer has agreed to comply with any conditions the Secretary determines necessary; or</text>
</subclause><subclause id="H17037B8C830E407C84C102755D983638"><enum>(II)</enum><text>development and testing that involves human clinical trials, if the eligible product developer has—</text> <item id="H71FE02FAD02E4816984940A02B529149"><enum>(aa)</enum> <subitem commented="no" display-inline="yes-display-inline" id="H52F26255B29F41CFAFF4A3B12684AB5D"><enum>(AA)</enum><text>submitted protocols, informed consent documents, and informational materials for testing that include protections that provide safety protections comparable to those provided by the REMS for the covered product; or</text>
</subitem><subitem id="HE877BDDA3DD3423A885DEFD81C34326E" indent="up1"><enum>(BB)</enum><text>otherwise satisfied the Secretary that such protections will be provided; and</text> </subitem></item><item id="HBC97418FC1AD4926973C0B21FFC152CB"><enum>(bb)</enum><text>met any other requirements the Secretary may establish.</text>
</item></subclause></clause><clause id="HFE6D97BAA19647008B0860F6C2B73D62"><enum>(iii)</enum><header>Notice</header><text>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 product.</text>
</clause></subparagraph></paragraph><paragraph id="H221FFC43C7494A59997A881631B37CDC"><enum>(3)</enum><header>Affirmative defense</header><text>In a civil action brought under paragraph (1), it shall be an affirmative defense, on which the defendant has the burden of persuasion by a preponderance of the evidence—</text>
<subparagraph id="H627A41F384C54AF2BBE6635BBCA5B46E"><enum>(A)</enum><text>that, on the date on which the eligible product developer requested to purchase sufficient quantities of the covered product from the license holder—</text>
<clause id="H43C80D3E06F341D0A4FAF14222BDACC6"><enum>(i)</enum><text>neither the license holder nor any of its agents, wholesalers, or distributors was engaged in the manufacturing or commercial marketing of the covered product; and</text>
</clause><clause id="H816265B676174D5B904E45AE59A23DBC"><enum>(ii)</enum><text>neither the license holder nor any of its agents, wholesalers, or distributors otherwise had access to inventory of the covered product to supply to the eligible product developer on commercially reasonable, market-based terms;</text>
</clause></subparagraph><subparagraph id="H623B71026BEE4713A62DB0041C5CF3D3"><enum>(B)</enum><text>that—</text> <clause id="HA99E682261184134AC10C4E1C5B75F13"><enum>(i)</enum><text>the license holder sells the covered product through agents, distributors, or wholesalers;</text>
</clause><clause id="H57B9253CACC840D6B59CBEF8F3C8B3C4"><enum>(ii)</enum><text>the license holder has placed no restrictions, explicit or implicit, on its agents, distributors, or wholesalers to sell covered products to eligible product developers; and</text>
</clause><clause id="H8CE14C5E4765400E8BCCB298749688D5"><enum>(iii)</enum><text>the covered product can be purchased by the eligible product developer in sufficient quantities on commercially reasonable, market-based terms from the agents, distributors, or wholesalers of the license holder; or</text>
</clause></subparagraph><subparagraph id="H5587A074871F41D9A205753BD1C5147C"><enum>(C)</enum><text display-inline="yes-display-inline">that the license holder made an offer to the individual specified pursuant to paragraph (2)(A)(iii)(III), by a means of communication (electronic, written, or both) specified pursuant to such paragraph, to sell sufficient quantities of the covered product to the eligible product developer at commercially reasonable market-based terms—</text>
<clause id="H8513170EDB444DADAC2AC263C7A0DAE6"><enum>(i)</enum><text>for a covered product that is not subject to a REMS with ETASU, by the date that is 14 days after the date on which the license holder received the request for the covered product, and the eligible product developer did not accept such offer by the date that is 7 days after the date on which the eligible product developer received such offer from the license holder; or</text>
</clause><clause id="HF108A312965D4DBAAE90F8D516186590"><enum>(ii)</enum><text>for a covered product that is subject to a REMS with ETASU, by the date that is 20 days after the date on which the license holder received the request for the covered product, and the eligible product developer did not accept such offer by the date that is 10 days after the date on which the eligible product developer received such offer from the license holder.</text>
</clause></subparagraph></paragraph><paragraph id="H3943692E2E0A4A72904E60AEC864240A"><enum>(4)</enum><header>Remedies</header>
<subparagraph id="H588D21DDB78E42579F5B9B5EBFFE3974"><enum>(A)</enum><header>In general</header><text>If an eligible product developer prevails in a civil action brought under paragraph (1), the court shall—</text>
<clause id="HFBBEDE01F1E84AA8BA0B156248C81D9D"><enum>(i)</enum><text>order the license holder to provide to the eligible product developer without delay sufficient quantities of the covered product on commercially reasonable, market-based terms;</text>
</clause><clause id="H3315CC87F11649E2B5460FA13491B9AD"><enum>(ii)</enum><text>award to the eligible product developer reasonable attorney's fees and costs of the civil action; and</text>
</clause><clause id="H58328004E24846E1B7DADF99BC47DA8B"><enum>(iii)</enum><text>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 reasonable, market-based terms, if the court finds, by a preponderance of the evidence—</text>
<subclause id="H8DF59C2515FC4F309F8C203D80CE44E1"><enum>(I)</enum><text>that the license holder delayed providing sufficient quantities of the covered product to the eligible product developer without a legitimate business justification; or</text>
</subclause><subclause id="H0177575CD2454655AA27D2FADE67EFBB"><enum>(II)</enum><text>that the license holder failed to comply with an order issued under clause (i).</text> </subclause></clause></subparagraph><subparagraph id="H46E3A341CC7844CEA85D8FFDC293D3A8"><enum>(B)</enum><header>Maximum monetary amount</header><text>A monetary amount awarded under subparagraph (A)(iii) shall not be greater than the revenue that the license holder earned on the covered product during the period—</text>
<clause id="HB6F9C52F31B0490F9D5E9093F0DC43B4"><enum>(i)</enum><text>beginning on—</text> <subclause id="H2B634059157D4932BCBAECDDEC29B7FD"><enum>(I)</enum><text>for a covered product that is not subject to a REMS with ETASU, the date that is 31 days after the date on which the license holder received the request; or</text>
</subclause><subclause id="HF5B444DE7DC64BFFB0A6F2C5125D21DE"><enum>(II)</enum><text>for a covered product that is subject to a REMS with ETASU, the date that is 31 days after the later of—</text>
<item id="H545D03AEF3F64DD3956DC524D7364C1D"><enum>(aa)</enum><text>the date on which the license holder received the request; or</text> </item><item id="H5E7916B2C0884583BC5BED4A5E4F270F"><enum>(bb)</enum><text>the date on which the license holder received a copy of the covered product authorization issued by the Secretary in accordance with paragraph (2)(B); and</text>
</item></subclause></clause><clause id="HBC867851D2A847329E69D2E4670FA7FC"><enum>(ii)</enum><text>ending on the date on which the eligible product developer received sufficient quantities of the covered product.</text>
</clause></subparagraph><subparagraph id="HBC8C635364174BB190434EB5332161EB"><enum>(C)</enum><header>Avoidance of delay</header><text>The court may issue an order under subparagraph (A)(i) before conducting further proceedings that may be necessary to determine whether the eligible product developer is entitled to an award under clause (ii) or (iii) of subparagraph (A), or the amount of any such award.</text>
</subparagraph></paragraph></subsection><subsection id="HADF8F0EB2AF14CDBAA35075674D48622"><enum>(c)</enum><header>Limitation of liability</header><text>A license holder for a covered product shall not be liable for any claim under Federal, State, 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 section, including transportation, handling, use, or disposal of the covered product by the eligible product developer.</text>
</subsection><subsection id="HED5B1780FA734D418CAFC5B8D0F4467C"><enum>(d)</enum><header>No violation of REMS</header><text display-inline="yes-display-inline">Section 505–1 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355-1">21 U.S.C. 355–1</external-xref>) is amended by adding at the end the following new subsection:</text>
<quoted-block display-inline="no-display-inline" id="H65D6D525A25D4122B0E503A1E29A32F3" style="OLC">
<subsection id="H4524710462334691815EEF846B16125B"><enum>(l)</enum><header>Provision of samples not a violation of strategy</header><text display-inline="yes-display-inline">The provision of samples of a covered product to an eligible product developer (as those terms are defined in section 121(a) of the <short-title>Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act</short-title>) 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 drug.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HA0FB1658E1554E84813FB81DE147CF3B"><enum>(e)</enum><header>Rule of construction</header>
<paragraph id="HBD4585F5923A4325AB8F5A61CD42B084"><enum>(1)</enum><header>Definition</header><text>In this subsection, the term <term>antitrust laws</term>—</text> <subparagraph id="H621E2209363344928694AF73E74E7545"><enum>(A)</enum><text>has the meaning given the term in subsection (a) of the first section of the Clayton Act (<external-xref legal-doc="usc" parsable-cite="usc/15/12">15 U.S.C. 12</external-xref>); and</text>
</subparagraph><subparagraph id="H3625C0C959CC4E31AF1095A5D7CB1332"><enum>(B)</enum><text>includes section 5 of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/45">15 U.S.C. 45</external-xref>) to the extent that such section applies to unfair methods of competition.</text>
</subparagraph></paragraph><paragraph id="H10BA87D091B748848E7DC876724E4D0B"><enum>(2)</enum><header>Antitrust laws</header><text>Nothing in this section shall be construed to limit the operation of any provision of the antitrust laws.</text>
</paragraph></subsection></section><section id="H4F5C29DF9E2F4D129BDB048CE7CA496E"><enum>122.</enum><header>REMS approval process for subsequent filers</header><text display-inline="no-display-inline">Section 505–1 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355-1">21 U.S.C. 355–1</external-xref>), as amended by section 121, is further amended—</text>
<paragraph id="H854C3D649FB34289B529741CFCEE9E67"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (g)(4)(B)—</text> <subparagraph id="H1A192ED3075C465C8A506FCC9576208A"><enum>(A)</enum><text display-inline="yes-display-inline">in clause (i) by striking <quote>or</quote> after the semicolon;</text>
</subparagraph><subparagraph id="HD7338CEF93CC483AAFC61DCDA6DD0FB0"><enum>(B)</enum><text>in clause (ii) by striking the period at the end and inserting <quote>; or</quote>; and</text> </subparagraph><subparagraph id="H8CC744E2E83445B1971171BE745B1144"><enum>(C)</enum><text>by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H9A03AC4837D5438F9115A5B22B16B630" style="OLC">
<clause commented="no" id="H445C41FC11EC48548385980F66791C81"><enum>(iii)</enum><text display-inline="yes-display-inline">accommodate different, comparable aspects of the elements to assure safe use for a drug that is the subject of an application under section 505(j), and the applicable listed drug.</text></clause><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="HBA9E4F6E9C1B48EBA5E726AC0D5BE5BA"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (i)(1), by striking subparagraph (C) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="H669CB91F1BCA4BE5AFCE69F14D8157AF" style="OLC"> <subparagraph id="H5C8C45F88E7541B3B4DD90805164C346"><enum>(C)</enum> <clause commented="no" display-inline="yes-display-inline" id="H628D283040C1477391268C1FDDA5ABE5"><enum>(i)</enum><text>Elements to assure safe use, if required under subsection (f) for the listed drug, which, subject to clause (ii), for a drug that is the subject of an application under section 505(j) may use—</text>
<subclause id="HB9576905A861415F9FC87A76C1D6E91D" indent="up1"><enum>(I)</enum><text>a single, shared system with the listed drug under subsection (f); or</text> </subclause><subclause id="HFC0C12FF50644E41B2E7D19595AB26A3" indent="up1"><enum>(II)</enum><text>a different, comparable aspect of the elements to assure safe use under subsection (f).</text>
</subclause></clause><clause id="HCA8C74A2737C47239C1E3D375A4631DD" indent="up1"><enum>(ii)</enum><text>The Secretary may require a drug that is the subject of an application under section 505(j) and the listed drug to use a single, shared system under subsection (f), if the Secretary determines that no different, comparable aspect of the elements to assure safe use could satisfy the requirements of subsection (f).</text></clause></subparagraph><after-quoted-block>; </after-quoted-block></quoted-block>
</paragraph><paragraph id="HA8A51D40E94E42F1B7F0DAF7D625D783"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (i), by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H2EA6EAB40B67488A86324EE314BC1212" style="OLC"> <paragraph id="HED1745F47CD0406087FA176EEA043247"><enum>(3)</enum><header>Shared REMS</header><text display-inline="yes-display-inline">If the Secretary approves, in accordance with paragraph (1)(C)(i)(II), a different, comparable aspect of the elements to assure safe use under subsection (f) for a drug that is the subject of an abbreviated new drug application under section 505(j), 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 505(j) or 505(b) that references the same listed drug.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block>
</paragraph><paragraph id="HC0173D80D8854899AA2907A8AD8C0B07"><enum>(4)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H902CBDC6C6FD41B28A35AA0C81ADF37D" style="OLC"> <subsection id="HEE14B737E93344E6BFBADD06F6A063A8"><enum>(m)</enum><header>Separate REMS</header><text>When used in this section, the terms <term>different, comparable aspect of the elements to assure safe use</term> or <term>different, comparable approved risk evaluation and mitigation strategies</term> means a risk evaluation and mitigation strategy for a drug that is the subject of an application under section 505(j) that uses different methods or operational means than the strategy required under subsection (a) for the applicable listed drug, or other application under section 505(j) with the same such listed drug, but achieves the same level of safety as such strategy.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section id="HADD382F3C9EA4ECAB812C3FF62E5BEAC"><enum>123.</enum><header>Rule of construction</header>
<subsection id="HA39667EE74CB436D88647EB358ED6D14"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Nothing in this subtitle, the amendments made by this subtitle, or in section 505–1 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355-1">21 U.S.C. 355–1</external-xref>), shall be construed as—</text>
<paragraph id="HE8C61420649D4B5799DEC2269EC0B176"><enum>(1)</enum><text>prohibiting a license holder from providing an eligible product developer access to a covered product in the absence of an authorization under this subtitle; or</text>
</paragraph><paragraph id="H1C589353A88D44E398038A55D2EBA00F"><enum>(2)</enum><text>in any way negating the applicability of a REMS with ETASU, as otherwise required under such section 505–1, with respect to such covered product.</text>
</paragraph></subsection><subsection id="H5FF9419EDB9E4BB39156DC4EA66B5FFC"><enum>(b)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this section, the terms <term>covered product</term>, <term>eligible product developer</term>, <term>license holder</term>, and <term>REMS with ETASU</term> have the meanings given such terms in section 121(a).</text> </subsection></section></subtitle><enum>II</enum><header>Extension of Public Health Programs</header> <section id="HF73D093907644B1B95076C9FA08F30DD" section-type="subsequent-section"><enum>201.</enum><header>Extension for community health centers, the National Health Service Corps, and teaching health centers that operate GME programs</header> <subsection id="H5A6BCE17757F4A9AAEA17A7544A7A918"> <enum>(a)</enum> <header>Community Health Centers Funding</header> <text>Section 10503(b)(1)(F) of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/254b-2">42 U.S.C. 254b–2(b)(1)(F)</external-xref>) is amended by striking <quote>fiscal year 2019</quote> and inserting <quote>each of fiscal years 2019 and 2020</quote>.</text>
</subsection><subsection id="HD632DA292A4F480DB8415D4C76E0B364">
<enum>(b)</enum>
<header>National Health Service Corps</header>
<text display-inline="yes-display-inline">Section 10503(b)(2)(F) of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/254b-2">42 U.S.C. 254b–2(b)(2)(F)</external-xref>) is amended by striking <quote>2018 and 2019</quote> and inserting <quote>2018, 2019, and 2020</quote>.</text>
</subsection><subsection id="HF18F1D75F642453CB3C7CA31D7DC09E7">
<enum>(c)</enum>
<header>Teaching health centers that operate graduate medical education programs</header>
<text>Section 340H(g)(1) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/256h">42 U.S.C. 256h(g)(1)</external-xref>) is amended by striking <quote>2018 and 2019</quote> and inserting <quote>2018, 2019, and 2020</quote>.</text> </subsection><subsection id="H31204F3F109C4FE9B6A546BDADC6B98D"><enum>(d)</enum><header>Application</header><text display-inline="yes-display-inline">Amounts appropriated pursuant to this section for fiscal year 2020 are subject to the requirements contained in <external-xref legal-doc="public-law" parsable-cite="pl/115/245">Public Law 115–245</external-xref> for funds for programs authorized under sections 330 through 340 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/254b">42 U.S.C. 254b–256</external-xref>).</text>
</subsection><subsection id="H6EB721D2CFDC475CB825F55E2CA3A3A0">
<enum>(e)</enum>
<header>Conforming amendment</header>
<text>Section 3014(h)(4) of title 18, United States Code, is amended by striking <quote>and section 50901(e) of the Advancing Chronic Care, Extenders, and Social Services Act</quote> and inserting <quote>, section 50901(e) of the Advancing Chronic Care, Extenders, and Social Services Act, and section 201(d) of the <short-title>Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act</short-title></quote>.</text>
</subsection></section><section id="H6C9E080C26584DE393113A659E2B0AC5">
<enum>202.</enum>
<header>Extension for special diabetes programs</header>
<subsection id="H043FAA09BF9A4F1882623DC8F71F68EF">
<enum>(a)</enum>
<header>Special Diabetes Program for Type I Diabetes</header>
<text>Section 330B(b)(2)(D) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/254c-2">42 U.S.C. 254c–2(b)(2)(D)</external-xref>) is amended by striking <quote>2018 and 2019</quote> and inserting <quote>2018, 2019, and 2020</quote>.</text>
</subsection><subsection id="HCCA50549E7C94115BBD6CEC109C60B30">
<enum>(b)</enum>
<header>Special Diabetes Program for Indians</header>
<text display-inline="yes-display-inline">Section 330C(c)(2)(D) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/254c-3">42 U.S.C. 254c–3(c)(2)(D)</external-xref>) is amended by striking <quote>2018 and 2019</quote> and inserting <quote>2018, 2019, and 2020</quote>.</text>
</subsection></section><section id="H5C26C538E5914CFEB911DE2B3172A407">
<enum>203.</enum>
<header>Extension for family-to-family health information centers</header>
<subsection id="H3C32646429EF413D865A4B6BA44F18D2"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 501(c) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/701">42 U.S.C. 701(c)(1)(A)(vii)</external-xref>) is amended by striking <quote>2018 and 2019</quote> and inserting <quote>2018, 2019, and 2020</quote>.</text> </subsection><subsection id="HE1D231B4C6BA4473A8D8DD7FC3354F1C"> <enum>(b)</enum><header>Conforming change</header> <text display-inline="yes-display-inline">Section 501(c)(3)(C) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/701">42 U.S.C. 701(c)(3)(C)</external-xref>) is amended by striking <quote>2018 and 2019</quote> and inserting <quote>2018, 2019, and 2020</quote>.</text>
</subsection></section><section id="H5956849A851B4CF291E405CC0E662AD5">
<enum>204.</enum>
<header>Extension for sexual risk avoidance education and personal responsibility education</header>
<subsection id="HFFBA295E6CF2478B8A3D84BDFD1CC1C1"><enum>(a)</enum><header>Sexual risk avoidance education</header><text display-inline="yes-display-inline">Subsections (a) and (f) of section 510 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/710">42 U.S.C. 710</external-xref>) are amended by striking <quote>2018 and 2019</quote> each place it appears and inserting <quote>2018, 2019, and 2020</quote>.</text>
</subsection><subsection id="HE52658E8C7654D86B5993C8F09340F50"><enum>(b)</enum><header>Personal responsibility education</header><text display-inline="yes-display-inline">Section 513 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/713">42 U.S.C. 713</external-xref>) is amended—</text> <paragraph id="HC0ACDF6FE15A48A389192BB81A66BCBE"> <enum>(1)</enum> <text>in subsection (a)(1)(A), by striking <quote>2019</quote> and inserting <quote>2020</quote>; and</text>
</paragraph><paragraph id="H59A4A9D70D464713938A517DD87E10B5">
<enum>(2)</enum>
<text>in subsection (a)(4), by striking <quote>2019</quote> each place it appears and inserting <quote>2020</quote>; and</text> </paragraph><paragraph id="HC13A71D5D61F412194BEAC1795000490"> <enum>(3)</enum> <text>in subsection (f), by striking <quote>2019</quote> and inserting <quote>2020</quote>.</text>
</paragraph></subsection></section>