text: 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.''.
target: New Aid for Trustworthy, Affordable Drugs Act (NAFTA Drugs Act) - Directs the United States Trade Representative (USTR) to enter into agreements with other North American Free Trade Agreement (NAFTA) countries (Canada and Mexico) to harmonize regulatory requirements such that drugs approved for commercial distribution in any NAFTA country may be imported or exported between NAFTA countries. Permits the USTR to enter into such an agreement only if the agreement provides for: (1) regulatory standards for drugs that are consistent with the requirements of this Act; (2) a seal, to be placed only by a registered pharmacy, certifying that a given drug meets the standards of the harmonization agreement and may be imported; (3) a unique system of tracking numbers identifying certain entities, including the drug manufacturer and the NAFTA county of origin; (4) the reimbursement by drug manufacturers of the Secretary of Health and Human Services for benefits derived from National Institutes of Health research.
  
  Sets a sunset of one year after the passage of this Act for the authority of the USTR to enter into harmonization agreements under this Act.
feat_title: To provide for the importation of drugs into the United States from Canada and Mexico, and for other purposes.