108th CONGRESS
1st Session
H. R. 2629
To provide for the importation of drugs into the United States from
Canada and Mexico, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
June 26, 2003
Mr. CROWLEY (for himself, Mr. SANDERS, Mr. CASE, Mr. HINCHEY, and Mrs. MALONEY)
introduced the following bill; which was referred to the Committee on Ways and
Means, and in addition to the Committee on Energy and Commerce, 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 provide for the importation of drugs into the United States from
Canada and Mexico, and for other purposes.
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 `New Aid for Trustworthy, Affordable Drugs Act
(NAFTA Drugs Act)'.
SEC. 2. HARMONIZATION OF DRUG LAWS REGARDING IMPORTATION INTO NAFTA COUNTRIES
FROM OTHER NAFTA COUNTRIES.
Section 803 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 383) is amended
by adding at the end the following subsection:
`(d)(1) Consistent with the North American Free Trade Agreement approved by
the Congress under section 101(a) of Public Law 103-182 (referred to in this
subsection as `NAFTA'), the United States Trade Representative shall seek to
enter into agreements with other NAFTA countries to harmonize regulatory requirements
for drugs such that drugs approved for commercial distribution in any NAFTA
country may be imported or exported from any NAFTA country into any NAFTA country.
`(2) The United States Trade Representative shall carry out this subsection
in consultation with the Secretary and the Commissioner of Food and Drugs.
`(3) The United States Trade Representative may enter into a harmonization agreement
under paragraph (1) only if such Representative determines as follows:
`(A) That the proposed agreement provides for regulatory standards for drugs
that are consistent with the requirements of this Act.
`(B) That the proposed agreement provides for--
`(i) the display of a seal on the labeling of the drugs involved, whose
purpose is to indicate that the drugs meet the standards of the harmonization
agreement and may be imported as provided in paragraph (1);
`(ii) uniform standards applicable to the display of such a seal in any
NAFTA country; and
`(iii) approval of such a seal by the appropriate health authority in any
NAFTA country before the display of the seal in that country, for the purpose
of ensuring that the seal complies with the uniform standards described
in clause (ii).
`(C) That the proposed agreement provides that a drug may not be imported
into a NAFTA country from another NAFTA country unless the labeling of the
drug bears a seal described in subparagraph (B).
`(D) That the proposed agreement provides for a system of unique tracking
numbers to indicate--
`(i) the manufacturer of the drug involved, the NAFTA country of origin,
and the wholesale distributors of the drug; and
`(ii) in the case of a prescription drug, the pharmacy that dispenses the
drug.
`(E) That the proposed agreement provides for--
`(i) the placement of a seal described in subparagraph (B) on the labeling
of a drug only by a pharmacy registered in accordance with this subparagraph;
`(ii) registration of pharmacies in each NAFTA country by the appropriate
health authority in each such country for the purpose of authorizing such
pharmacies to place a seal described in subparagraph (B) on the labeling
of drugs; and
`(iii) uniform standards applicable to such registration.
`(F) That the proposed agreement--
`(i) requires drug manufacturers to reimburse the Secretary of Health and
Human Services for benefits derived by such manufacturers from research
performed by the National Institutes of Health; and
`(ii) authorizes use of such reimbursement to pay the expenses incurred
by the Food and Drug Administration in approving seals under subparagraph
(B) and registering pharmacies under subparagraph (E).
`(G) That the proposed agreement prohibits any discrimination by any person
in the manufacture, distribution, or sale of any drug that bears a seal described
in subparagraph (B), on the basis of a prospective customer's citizenship
or residency in a NAFTA country, or on the basis of a request for shipment
of the drug to any NAFTA country.
`(4) The authority of the United States Trade Representative to enter a harmonization
agreement under paragraph (1) terminates one year after the date of the enactment
of New Aid for Trustworthy, Affordable Drugs Act (NAFTA Drugs Act).
`(5) For purposes of this subsection, the term `NAFTA country' means each of
the United States, Canada, and the United Mexican States--
`(A) for such time as NAFTA is in force with respect to such country; and
`(B) in the case of each of Canada and the United Mexican States, for such
time as the United States applies NAFTA to such country.'.
END
