1.This Act may be cited as the
Prescription Drug Affordability
Act
.
<enum>I</enum><header>Amendments to
Internal Revenue Code of 1986</header>
<section id="H0982045C70434D6A9141492BF8004407"><enum>101.</enum><header>Income tax
credit for prescription drugs purchased by individuals who have attained
retirement age</header>
<subsection id="H6B4C0DE40BF74B679CDB2EF58CB304CB"><enum>(a)</enum><header>In
general</header><text>Subpart A of part IV of subchapter A of chapter 1 of the
Internal Revenue Code of 1986 (relating to nonrefundable personal credits) is
amended by inserting after section 25D the following new section:</text>
<quoted-block id="HD3B4CE962E814F8CA5DD1528B5E91202">
<section id="H03A6E4F4C4C24FCAB9233CCCE4069D52"><enum>25E.</enum><header>Prescription
drugs purchased by individuals who have attained social security retirement
age</header>
<subsection id="HD2EEC3D1693E423FBF57CDA084B19760"><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="HA31AEE6313EC4EE4978933B8B951E805"><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="H7C02C160D2294EEFA91DEF2601754010"><enum>(c)</enum><header>Denial of double
benefit</header>
<paragraph id="H3788714F50EE4B7500E64451D37DBF83"><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="H33D5657B4A6D484795C8D0624E4FB9F1"><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="HE19164DDDBF84167A4CA0024F3E7F2B0"><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="HF27502AE2DA74FD1869E66536E4BD700"><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 25D the following new item:</text>
<quoted-block id="H5A1EBFB1B81F4161AE7D02F382A03EE2" style="OLC">
<toc regeneration="no-regeneration">
<toc-entry level="section">Sec. 25E. 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="HC05062218F2646D595BCA2978FEBF220"><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><enum>II</enum><header>Amendments to
Federal Food, Drug, and Cosmetic Act</header>
<section id="H75BA24B1887447308ECE2EBB9892B3E"><enum>201.</enum><header>Facilitation of
importation of drugs approved by food and drug administration</header>
<subsection id="H6692025B80304A8CA6EB8500F716B04F"><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> (21
U.S.C. 381 et seq.) is amended—</text>
<paragraph id="H5E18CCE68117431C99267C1904DD43B"><enum>(1)</enum><text>by
striking section 804; and</text>
</paragraph><paragraph id="H2F91DB47DBF74799BDFB5B362EBAC170"><enum>(2)</enum><text>in section
801(d)—</text>
<subparagraph id="HF229DFFC003849ADB886007566329815"><enum>(A)</enum><text>by striking
paragraph (2); and</text>
</subparagraph><subparagraph id="HB102113A7D0045D1AE6141B9AE6B4F62"><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="H4D0B225B8F764101A8729D7CE47FB250">
<subsection id="HB4BFF010AC11498F93301B92E1719146"><enum>(d)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H3980B9ED98624686AD37ECC22C8563D4"><enum>(1)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H705F09180A7042A48D03F8154C879E84"><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 id="H406105BA1E81408DB7A087A695CED885" indent="up2"><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 id="HACAF35F228324E2ABA21C05F2266C624" indent="up2"><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="HA836EE99C32141AD00C4B6FA5D9F662B"><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="HAF17EBE4D32242BABA76005B7F4435CA"><enum>(ii)</enum><text>the drug is not adulterated or
misbranded.</text>
</clause></subparagraph><subparagraph id="HA480145FFD684C4C887F52593CD2746C" indent="up2"><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="HB2C5D1AA28B342E8B32881E2D735995D"><enum>(i)</enum><text>approve the application; or</text>
</clause><clause id="H0A48FF3B3F734D0B81342E88CB53C2B"><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 id="HA64CFF7C5E394FC492EBBE14DB2F714" indent="up2"><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="HC12352A3A9E9420FAAF700558C0027F3"><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> (21
U.S.C. 381(d)) is amended—</text>
<paragraph id="H564B4C3324DE4B3897F28DECB92F27C9"><enum>(1)</enum><text>by redesignating
paragraphs (3) and (4) as paragraphs (2) and (3), respectively;</text>
</paragraph><paragraph id="HA2AA778643F0421EB225B859B2B02994"><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="H77DA44D5DB7B47C880D64653E84FA031"><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="H05346838B6E84089AB3E00C3532662DC"><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> (21 U.S.C. 353(b)) is amended by adding at the end the following
paragraph:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="HFEB1D7FECCA54E4D9F41B029B0E0ED1D">
<paragraph id="HEDC2A0D9CEC64393A179CF4BEB000B6" indent="up1"><enum>(6)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HC495846772934FA38DCC417CC900E4A5"><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 id="H06AD494CF3C8406600F8DB00E766AF37" indent="up1"><enum>(i)</enum><text>the sale was made in compliance with
this Act, the Controlled Substances Act, and State laws that are applicable to
the sale of the drug; and</text>
</clause><clause id="H2CA10BC2D99742AC85ECE8535F13679B" indent="up1"><enum>(ii)</enum><text>accurate information regarding
compliance with this Act, the Controlled Substances Act, and such State laws is
posted on the Internet site.</text>
</clause></subparagraph><subparagraph id="HE5DDEE81C40B437FA699DFEDBBDE2EA4" indent="up1"><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="H7B82DE1C9EB746B19809E363A95E21B2"><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="HA241F53A999446A2B0F1532B48BFA29"><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 id="H0F642C4C1891494E823843DC831684B0" indent="up1"><enum>(C)</enum><text>Subparagraph (A) may not be construed
as authorizing the Secretary to enforce any violation of State law.</text>
</subparagraph><subparagraph id="HF04177D6DE714A71A9EB6936B7BC5F29" indent="up1"><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="HD5382DDDC12C4BCAB9A4C2E55F808E7"><enum>203.</enum><header>Regulations of
Secretary of Health and Human Services; effective date</header>
<subsection id="HD1A133D4B6DF4FC284AB00EC102CB14"><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="H4BADE4262F0B40BB96C6CC13E07DC1E7"><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>