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<bill bill-stage="Introduced-in-House" dms-id="H2B229DC45BB44D39B6C4A6D83429FB22" public-private="public" bill-type="olc"> 
<metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
<dublinCore>
<dc:title>109 HR 578 IH: Prescription Drug Affordability Act</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2005-02-02</dc:date>
<dc:format>text/xml</dc:format>
<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>
</dublinCore>
</metadata>
<form> 
<distribution-code display="yes">I</distribution-code> 
<congress>109th CONGRESS</congress>
<session>1st Session</session>
<legis-num>H. R. 578</legis-num> 
<current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber> 
<action> 
<action-date date="20050202">February 2, 2005</action-date> 
<action-desc><sponsor name-id="P000583">Mr. Paul</sponsor> 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>To amend the Internal Revenue Code of 1986 with respect to the purchase of prescription drugs by individuals who have attained retirement age, and to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs and the sale of such drugs through Internet sites.</official-title> 
</form> 
<legis-body id="H4C65EA05325D4591B6B660B54B5D56F1" style="OLC"> 
<section section-type="section-one" id="H2C895308F566415FBC123BF891925BFB" display-inline="no-display-inline"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Prescription Drug Affordability Act</short-title></quote>.</text></section> 
<title id="H54BA556FB11642D187C0A2B7364C5EA1"><enum>I</enum><header>Amendments to Internal Revenue Code of 1986</header> 
<section id="H8C0BD7FEDFD84A79BF161330D8519EF1"><enum>101.</enum><header>Income tax credit for prescription drugs purchased by individuals who have attained retirement age</header> 
<subsection id="H3B0ABCA4131D43B39CFE83632E8F5CE2"><enum>(a)</enum><header>In general</header><text>Subpart A of part IV of subchapter A of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/26/1">chapter 1</external-xref> of the Internal Revenue Code of 1986 (relating to nonrefundable personal credits) is amended by inserting after section 25B the following new section:</text> 
<quoted-block id="HE8B75E564A7B465896820096FF3D19D8"> 
<section id="HDC87EAAD400948D3B725182CA124CF83"><enum>25C.</enum><header>Prescription drugs purchased by individuals who have attained social security retirement age</header> 
<subsection id="H160F08A5CAE046388BF7D38E85EDB0AB"><enum>(a)</enum><header>In general</header><text>In the case of an individual who has attained social security retirement age, there shall be allowed as a credit against the tax imposed by this chapter for the taxable year an amount equal to 80 percent of the amount paid by the taxpayer during the taxable year (and not compensated for by insurance or otherwise) for any prescribed drug (as defined in section 213(d)(3)) for use by such individual.</text></subsection> 
<subsection id="HACAE913B05E54EB7B3000995C8AA1175"><enum>(b)</enum><header>Social security retirement age</header><text>For purposes of this section, the term <term>social security retirement age</term> means retirement age (as defined in section 216(l)(1) of the <act-name parsable-cite="SSA">Social Security Act</act-name>).</text></subsection> 
<subsection id="H0318AE48441A425C9082AF00E10002B2"><enum>(c)</enum><header>Denial of double benefit</header> 
<paragraph id="HA6F1F0AE95EF411B98C1B0A017FDCEF"><enum>(1)</enum><header>Coordination with medical expense deduction</header><text>The amount which would (but for this subsection) be taken into account by the taxpayer under section 213 for the taxable year shall be reduced by the credit (if any) allowed by this section to the taxpayer for such year.</text></paragraph> 
<paragraph id="H464F2A94159C497788D5073BD87602D"><enum>(2)</enum><header>Coordination with medical and health savings accounts</header><text>No credit shall be allowed under this section for amounts paid from any Archer MSA (as defined in section 220(d)) or any health savings account (as defined in section 223(d)).</text></paragraph></subsection> 
<subsection id="HE5433B960EF84F4292002D398B325FF8"><enum>(d)</enum><header>Election not to have credit apply</header><text>This section shall not apply to a taxpayer for a taxable year if the taxpayer elects not to have this section apply for such year.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection> 
<subsection id="HB789485282434BC9AD21C03CC8953558"><enum>(b)</enum><header>Clerical amendment</header><text>The table of sections for subpart A of part IV of subchapter A of chapter 1 of such Code is amended by inserting after the item relating to section 25B the following new item:</text> 
<quoted-block style="OLC" id="H63B0B6EAA311404BA8754CA600BDDE1F"> 
<toc regeneration="no-regeneration"> 
<toc-entry level="section">Sec. 25C. Prescription drugs purchased by individuals who have attained social security retirement age</toc-entry></toc><after-quoted-block></after-quoted-block></quoted-block></subsection> 
<subsection id="H06503646AB494554B377DB20B110E07D"><enum>(c)</enum><header>Effective date</header><text>The amendments made by this section shall apply to taxable years beginning more than 1 year after the date of the enactment of this Act.</text></subsection></section></title> 
<title id="HF475AB36649746C9A8CBD4EAA7D97F03"><enum>II</enum><header>Amendments to Federal Food, Drug, and Cosmetic Act</header> 
<section id="HCBC695B2F20D4E80B785B3A14D230321"><enum>201.</enum><header>Facilitation of importation of drugs approved by food and drug administration</header> 
<subsection id="H537F9D95C7144B58B13CB7FD42A08262"><enum>(a)</enum><header>In general</header><text>Chapter VIII of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/381">21 U.S.C. 381 et seq.</external-xref>) is amended—</text> 
<paragraph id="HF486CFC52B3D408C8FDBCCAE35E6BDEF"><enum>(1)</enum><text>by striking section 804; and</text></paragraph> 
<paragraph id="HCEB678B93F3C4FCD009506AB1C9D0066"><enum>(2)</enum><text>in section 801(d)—</text> 
<subparagraph id="H83D05E7C4F56456CB3AECB31BC7391F"><enum>(A)</enum><text>by striking paragraph (2); and</text></subparagraph> 
<subparagraph id="HDA5C331CBF79409B95E8367400001540"><enum>(B)</enum><text>by striking <quote>(d)(1)</quote> and all that follows through the end of paragraph (1) and inserting the following:</text> 
<quoted-block id="H7F2045C32B6745F5904D97EB04F67100"> 
<subsection id="HF60ECE1CD45B4432AE68C43D75D2C504"><enum>(d)</enum> 
<paragraph display-inline="yes-display-inline" id="H9EE1A609EFDA4021AA6C17B86F648E8B"><enum>(1)</enum> 
<subparagraph display-inline="yes-display-inline" id="H898C344248014AF592FD63A8D977C178"><enum>(A)</enum><text>A person who meets applicable legal requirements to be an importer of drugs described in subparagraph (B) may import such a drug (without regard to whether the person is a manufacturer of the drug) if the person submits to the Secretary an application to import the drug and the Secretary approves the application.</text></subparagraph> 
<subparagraph indent="up2" id="HE65E6E3415DD4548918B000050F86778"><enum>(B)</enum><text>For purposes of subparagraph (A), the drugs described in this subparagraph are drugs that are subject to section 503(b)(1) or that are composed wholly or partly of insulin.</text></subparagraph> 
<subparagraph indent="up2" id="HE8934E86DC4249498444DFA6A9EE129"><enum>(C)</enum><text>The Secretary shall approve an application under subparagraph (A) if the application demonstrates that the drug to be imported meets all requirements under this Act for the admission of the drug into the United States, including demonstrating that—</text> 
<clause id="HD5ADD1A734DE4EF49C60AC00C74B4B06"><enum>(i)</enum><text>an application for the drug has been approved under section 505, or as applicable, under section 351 of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name>; and</text></clause> 
<clause id="H2DA9A9AEA45144A287E2D19DDF57DC7C"><enum>(ii)</enum><text>the drug is not adulterated or misbranded.</text></clause></subparagraph> 
<subparagraph indent="up2" id="HA9D999A60E9647678152E21616E7C817"><enum>(D)</enum><text>Not later than 60 days after the date on which an application under subparagraph (A) is submitted to the Secretary, the Secretary shall—</text> 
<clause id="H7933C3C3C6BB4A2A9900AE5E56677FFE"><enum>(i)</enum><text>approve the application; or</text></clause> 
<clause id="H399ED6FD73CB4F4990F72F61C98CC422"><enum>(ii)</enum><text>refuse to approve the application and provide to the person who submitted the application the reason for such refusal.</text></clause></subparagraph> 
<subparagraph indent="up2" id="HFE5B351031B24A80B4E6CE73AA4272CC"><enum>(E)</enum><text>This paragraph may not be construed as affecting any right secured by patent.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection> 
<subsection id="H9FF0A9D52C0E417CB59018476F70ED86"><enum>(b)</enum><header>Conforming amendments</header><text>Section 801(d) of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/381">21 U.S.C. 381(d)</external-xref>) is amended—</text> 
<paragraph id="H8E384FAA512B4CB099698B61B6C89C95"><enum>(1)</enum><text>by redesignating paragraphs (3) and (4) as paragraphs (2) and (3), respectively;</text></paragraph> 
<paragraph id="HD4A612F19EAC458AA6D2F71E30C2A75F"><enum>(2)</enum><text>in subclause (III) of paragraph (2)(A)(i) (as redesignated by this subsection), by striking <quote>paragraph (4)</quote> and inserting <quote>paragraph (3)</quote>; and </text></paragraph> 
<paragraph id="HAD82160F38D54F59B38700A507FA0899"><enum>(3)</enum><text>in paragraph (3) (as redesignated by this subsection), by striking <quote>paragraph (3)</quote> each place such term appears and inserting <quote>paragraph (2)</quote>.</text></paragraph></subsection></section> 
<section id="H1511B5C0DEF74A4B86155CBE45E16856"><enum>202.</enum><header>Internet sales of prescription drugs</header><text display-inline="no-display-inline">Section 503(b) of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/353">21 U.S.C. 353(b)</external-xref>) is amended by adding at the end the following paragraph:</text> 
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="HBECA72D40A88415584BB935776E490F7"> 
<paragraph indent="up1" id="HA330514F13E54DBBB433C589C494EE6B"><enum>(6)</enum> 
<subparagraph display-inline="yes-display-inline" id="H14550FDAE260491E982B8119992CE471"><enum>(A)</enum><text>With respect to the interstate sale of a prescription drug through an Internet site, the Secretary may not with respect to such sale take any action under this Act against any of the persons involved if—</text> 
<clause indent="up1" id="H89082D72C9124325959DC07400E908F4"><enum>(i)</enum><text>the sale was made in compliance with this Act and with State laws that are applicable to the sale of the drug; and</text></clause> 
<clause indent="up1" id="H0A1866B01FEE4402830200121EA588AC"><enum>(ii)</enum><text>accurate information regarding compliance with this Act and such State laws is posted on the Internet site.</text></clause></subparagraph> 
<subparagraph indent="up1" id="H8E21B221DA12463E84366E2508FDD59F"><enum>(B)</enum><text>For purposes of subparagraph (A), the sale of a prescription drug by a person shall be considered to be an interstate sale of the drug through an Internet site if—</text> 
<clause id="H16DEB5E356D349539F7C5114FAE127CB"><enum>(i)</enum><text>the purchaser of the drug submits the purchase order for the drug, or conducts any other part of the sales transaction for the drug, through an Internet site; and</text></clause> 
<clause id="HC0F20AAC27F643AB84A1D4F4F8FCA797"><enum>(ii)</enum><text>pursuant to such sale, the person introduces the drug into interstate commerce or delivers the drug for introduction into such commerce.</text></clause></subparagraph> 
<subparagraph indent="up1" id="H9EEFDFB821F24ED5804B3717B2E195CD"><enum>(C)</enum><text>Subparagraph (A) may not be construed as authorizing the Secretary to enforce any violation of State law.</text></subparagraph> 
<subparagraph indent="up1" id="HFDF91396328A4D6D97864943BEC6E412"><enum>(D)</enum><text>For purposes of this paragraph, the term <term>prescription drug</term> means a drug that is subject to paragraph (1).</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></section> 
<section id="H73FF9B64DF4248DC00E0E5AC31CCE6C"><enum>203.</enum><header>Regulations of Secretary of Health and Human Services; effective date</header> 
<subsection id="H5327C146C2674F8ABE8FE0EF07AE955D"><enum>(a)</enum><header>Regulations</header><text>Before the expiration of the period specified in subsection (b), the Secretary of Health and Human Services shall promulgate regulations to carry out the amendments to the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> that are made by sections 201 and 202.</text></subsection> 
<subsection id="H31A09DAD2D7548009EF0D916D101D582"><enum>(b)</enum><header>Effective date</header><text>The amendments to the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> that are made by sections 201 and 202 take effect upon the expiration of the one-year period beginning on the date of the enactment of this Act, without regard to whether the regulations required in subsection (a) have been promulgated.</text></subsection></section></title> 
</legis-body> 
</bill> 

