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<dc:title>119 HR 8857 IH: Next Generation Medicines Act of 2026</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2026-05-15</dc:date>
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<dc:language>EN</dc:language>
<dc:rights>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.</dc:rights>
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<distribution-code display="yes">I</distribution-code><congress display="yes">119th CONGRESS</congress><session display="yes">2d Session</session><legis-num display="yes">H. R. 8857</legis-num><current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber><action display="yes"><action-date date="20260515">May 15, 2026</action-date><action-desc><sponsor name-id="M001206">Mr. Morelle</sponsor> (for himself, <cosponsor name-id="G000583">Mr. Gottheimer</cosponsor>, <cosponsor name-id="P000048">Mr. Pfluger</cosponsor>, and <cosponsor name-id="K000398">Mr. Kean</cosponsor>) introduced the following bill; which was referred to the <committee-name committee-id="HIF00">Committee on Energy and Commerce</committee-name>, and in addition to the Committee on <committee-name committee-id="HWM00">Ways and Means</committee-name>, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned</action-desc></action><legis-type>A BILL</legis-type><official-title display="yes">To amend title XI of the Social Security Act to adjust which engineered cyclic peptides are qualifying single source drugs for purposes of the Drug Price Negotiation Program.</official-title></form><legis-body id="HF0D38E410D3D4F00814E61A5DC0EA52B" style="OLC"> 
<section id="H3C79E383A0FD4176B5B56D2CC471AFD4" section-type="section-one"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Next Generation Medicines Act of 2026</short-title></quote> or the <quote><short-title>Next GEN Act of 2026</short-title></quote>.</text></section> <section id="H1D0347F831024165B439460173887FF5"><enum>2.</enum><header>Adjusting rules for engineered cyclic peptides under Drug Price Negotiation Program</header> <subsection id="HC06D17AF3128438B8F70ECF0663FFFA9"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1192(e) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320f-1">42 U.S.C. 1320f–1(e)</external-xref>) is amended—</text> 
<paragraph id="H74E3A7806F5149F68B0741B5A8DC28C6"><enum>(1)</enum><text>in paragraph (1)(A)(ii), by inserting <quote>(or, in the case of an engineered cyclic peptide (as defined in paragraph (5)), 11 years)</quote> after <quote>7 years</quote>; and</text></paragraph> <paragraph id="H2E220541D4CB47D79267A216CAAD781C"><enum>(2)</enum><text>by adding at the end the following new paragraph:</text> 
<quoted-block style="OLC" id="HAC681082B7864477A7D1844C166022F1" display-inline="no-display-inline"> 
<paragraph id="HF7F78A4EA623466991EA1C1D68797E43"><enum>(5)</enum><header>Engineered cyclic peptide defined</header><text display-inline="yes-display-inline">In this subsection, the term <term>engineered cyclic peptide</term> means a polymer that—</text> <subparagraph id="H1632C9B828944DC0B232DC59CBB76365"><enum>(A)</enum><text>is composed principally of amino acids;</text></subparagraph> 
<subparagraph id="H96CD44E5EF534F178C66AD029D4E3365"><enum>(B)</enum><text display-inline="yes-display-inline">contains not less than 1 cyclic structure produced through head-to-tail cyclization, head-to-side-chain cyclization, side-chain-to-tail cyclization, or side-chain-to-side-chain cyclization;</text></subparagraph> <subparagraph id="H95D8C0C08B5141B0A9B8792FFDB723B8"><enum>(C)</enum><text>contains not more than 40 amino acids;</text></subparagraph> 
<subparagraph id="H889C1804619F427D937D9222BAA03FE5"><enum>(D)</enum><text>was identified for development using a genetically encoded library screening method;</text></subparagraph> <subparagraph id="H3E1FD29CAE4C4E5490960A936AE495C1"><enum>(E)</enum><text>is not naturally derived; and</text></subparagraph> 
<subparagraph id="H7D8021906EEE4ECCA3BF4A2C81C00D18"><enum>(F)</enum><text>is orally administered, inhaled, or otherwise self-administered.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection> <subsection id="H8E969795867E4D51BA0C00CC3D9BEC6B"><enum>(b)</enum><header>Effective date</header><text display-inline="yes-display-inline">The amendments made by this section shall apply with respect to lists published under section 1192(a) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320f-1">42 U.S.C. 1320f–1(a)</external-xref>) on or after the date of the enactment of this section.</text></subsection></section> 
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