I
106TH CONGRESS
2D SESSION
H. R. 3636
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
FEBRUARY 10, 2000
Mr. PAUL introduced the following bill; which was referred to the Committee
on 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 impor-
tation of prescription drugs and the sale of such drugs
through Internet sites.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Pharmaceutical Free-
dom Act of 2000’’.
TITLE I—AMENDMENTS TO IN-
TERNAL REVENUE CODE OF
1986
SEC. 101. INCOME TAX CREDIT FOR PRESCRIPTION DRUGS
PURCHASED BY INDIVIDUALS WHO HAVE AT-
TAINED RETIREMENT AGE.
(a) IN GENERAL.—Subpart A of part IV of sub-
chapter 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 INDIVID-
UALS WHO HAVE ATTAINED SOCIAL SECU-
RITY 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 retire-
ment 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 re-
duced 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 relat-
ing 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 FED-
ERAL FOOD, DRUG, AND COS-
METIC ACT
SEC. 201. FACILITATION OF IMPORTATION OF DRUGS AP-
PROVED BY FOOD AND DRUG ADMINISTRA-
TION.
(a) IN GENERAL.—Section 801(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) is
amended—
(1) by striking paragraph (2); and
(2) 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 re-
quirements to be an importer of drugs described in sub-
paragraph (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 im-
port 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 ap-
proved 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 pro-
vide to the person who submitted the application the
reason for such refusal.
‘‘(E) This paragraph may not be construed as affect-
ing 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
‘‘(ii) pursuant to such sale, the person intro-
duces the drug into interstate commerce or delivers
the drug for introduction into such commerce.
‘‘(C) Subparagraph (A) may not be construed as au-
thorizing the Secretary to enforce any violation of State
law.
‘‘(D) For purposes of this paragraph, the term ‘pre-
scription 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 pe-
riod 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 Cos-
metic Act that are made by sections 201 and 202.
(b) EFFECTIVE DATE.—The amendments to the Fed-
eral Food, Drug, and Cosmetic Act that are made by sec-
tions 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 re-
quired in subsection (a) have been promulgated.
Æ