[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2801 Introduced in House (IH)]
107th CONGRESS
1st Session
H. R. 2801
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.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
August 2, 2001
Mr. Paul (for himself and Mr. Schaffer) introduced the following bill;
which was referred to the Committee on Energy and Commerce, and in
addition to the Committee on Ways and Means, 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
_______________________________________________________________________
A BILL
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Prescription Drug Affordability
Act''.
TITLE I--AMENDMENTS TO INTERNAL REVENUE CODE OF 1986
SEC. 101. INCOME TAX CREDIT FOR PRESCRIPTION DRUGS PURCHASED BY
INDIVIDUALS WHO HAVE ATTAINED RETIREMENT AGE.
(a) In General.--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 25A the
following new section:
``SEC. 25B. PRESCRIPTION DRUGS PURCHASED BY INDIVIDUALS WHO HAVE
ATTAINED SOCIAL SECURITY RETIREMENT AGE.
``(a) In General.--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.
``(b) Social Security Retirement Age.--For purposes of this
section, the term `social security retirement age' means retirement age
(as defined in section 216(l)(1) of the Social Security Act).
``(c) Denial of Double Benefit.--
``(1) Coordination with medical expense deduction.--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.
``(2) Coordination with medical savings accounts.--No
credit shall be allowed under this section for amounts paid
from any medical savings account (as defined in section
220(d)).
``(d) Election Not To Have Credit Apply.--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.''
(b) Clerical Amendment.--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 25A the following new
item:
``Sec. 25B. Prescription drugs purchased
by individuals who have
attained social security
retirement age.''
(c) Effective Date.--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.
TITLE II--AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT
SEC. 201. FACILITATION OF IMPORTATION OF DRUGS APPROVED BY FOOD AND
DRUG ADMINISTRATION.
(a) In General.--Chapter VIII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381 et seq.) is amended--
(1) by striking section 804 (as added by section 745(c)(2)
of Public Law 106-387); and
(2) in section 801(d)--
(A) by striking paragraph (2); and
(B) by striking ``(d)(1)'' and all that follows
through the end of paragraph (1) and inserting the
following:
``(d)(1)(A) 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.
``(B) 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.
``(C) 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--
``(i) an application for the drug has been approved under
section 505, or as applicable, under section 351 of the Public
Health Service Act; and
``(ii) the drug is not adulterated or misbranded.
``(D) Not later than 60 days after the date on which an application
under subparagraph (A) is submitted to the Secretary, the Secretary
shall--
``(i) approve the application; or
``(ii) refuse to approve the application and provide to the
person who submitted the application the reason for such
refusal.
``(E) This paragraph may not be construed as affecting any right
secured by patent.''.
(b) Conforming Amendments.--Section 801(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 381(d)) is amended--
(1) by redesignating paragraphs (3) and (4) as paragraphs
(2) and (3), respectively; and
(2) in paragraph (3) (as so redesignated) by striking
``paragraph (3)'' each place such term appears and inserting
``paragraph (2)''.
SEC. 202. INTERNET SALES OF PRESCRIPTION DRUGS.
Section 503(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 353(b)) is amended by adding at the end the following paragraph:
``(6)(A) 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--
``(i) the sale was made in compliance with this Act and
with State laws that are applicable to the sale of the drug;
and
``(ii) accurate information regarding compliance with this
Act and such State laws is posted on the Internet site.
``(B) 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--
``(i) 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
``(ii) pursuant to such sale, the person introduces the
drug into interstate commerce or delivers the drug for
introduction into such commerce.
``(C) Subparagraph (A) may not be construed as authorizing the
Secretary to enforce any violation of State law.
``(D) For purposes of this paragraph, the term `prescription drug'
means a drug that is subject to paragraph (1).''.
SEC. 203. REGULATIONS OF SECRETARY OF HEALTH AND HUMAN SERVICES;
EFFECTIVE DATE.
(a) Regulations.--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 Federal Food,
Drug, and Cosmetic Act that are made by sections 201 and 202.
(b) Effective Date.--The amendments to the Federal Food, Drug, and
Cosmetic Act 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.
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