[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2629 Introduced in House (IH)]







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.''.
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