[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 698 Introduced in House (IH)]







107th CONGRESS
  1st Session
                                H. R. 698

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
     importation of certain prescription drugs by pharmacists and 
                              wholesalers.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 14, 2001

 Mr. Sanders (for himself, Mr. Deutsch, Mr. Shows, Mr. Brown of Ohio, 
Mr. Bonior, Ms. Kaptur, Ms. DeLauro, Mr. Conyers, Mr. Nadler, Mrs. Mink 
of Hawaii, Mr. Oberstar, Mr. Crowley, Mr. Abercrombie, Mr. DeFazio, Mr. 
    Hilliard, Mr. Filner, Mr. Olver, Mr. LaFalce, and Mr. Hinchey) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
     importation of certain prescription drugs by pharmacists and 
                              wholesalers.

    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 Reimportation, 
Improvement, Correction, and Enhancement Act''.

SEC. 2. AMENDMENTS TO PROGRAM FOR IMPORTATION OF CERTAIN PRESCRIPTION 
              DRUGS BY PHARMACISTS AND WHOLESALERS.

    Section 804 of the Federal Food, Drug, and Cosmetic Act (as added 
by section 745(c)(2) of Public Law 106-387) is amended--
            (1) by striking subsections (e) and (f) and inserting the 
        following subsections:
    ``(e) Testing; Approved Labeling.--
            ``(1) Testing.--Regulations under subsection (a)--
                    ``(A) shall require that testing referred to in 
                paragraphs (6) through (8) of subsection (d) be 
                conducted by the importer of the covered product 
                pursuant to subsection (a), or the manufacturer of the 
                product;
                    ``(B) shall require that, if such tests are 
                conducted by the importer, information needed to 
                authenticate the product being tested be supplied by 
                the manufacturer of such product to the importer; and
                    ``(C) shall provide for the protection of any 
                information supplied by the manufacturer under 
                subparagraph (B) that is a trade secret or commercial 
                or financial information that is privileged or 
                confidential.
            ``(2) Approved labeling.--For purposes of importing a 
        covered product pursuant to subsection (a), the importer 
        involved may use the labeling approved for the product under 
        section 505, notwithstanding any other provision of law.
    ``(f) Discretion of Secretary Regarding Testing.--The Secretary may 
waive or modify testing requirements described in subsection (d) if, 
with respect to specific countries or specific distribution chains, the 
Secretary has entered into agreements or otherwise approved 
arrangements that the Secretary determines ensure that the covered 
products involved are not adulterated or in violation of section 
505.'';
            (2) by striking subsections (h) and (i) and inserting the 
        following subsections:
    ``(h) Prohibited Agreements; Nondiscrimination.--
            ``(1) Prohibited agreements.--No manufacturer of a covered 
        product may enter into a contract or agreement that includes a 
        provision to prevent the sale or distribution of covered 
        products imported pursuant to subsection (a).
            ``(2) Nondiscrimination.--No manufacturer of a covered 
        product may take actions that discriminate against, or cause 
        other persons to discriminate against, United States 
        pharmacists, wholesalers, or consumers regarding the sale or 
        distribution of covered products.
    ``(i) Study and Report.--
            ``(1) Study.--The Comptroller General of the United States 
        shall conduct a study on the imports permitted under this 
        section, taking into consideration the information received 
        under subsection (a). In conducting such study, the Comptroller 
        General shall--
                    ``(A) evaluate importers' compliance with 
                regulations, determine the number of shipments, if any, 
                permitted under this section that have been determined 
                to be counterfeit, misbranded, or adulterated; and
                    ``(B) consult with the United States Trade 
                Representative and United States Patent and Trademark 
                Office to evaluate the effect of importations permitted 
                under this section on trade and patent rights under 
                Federal law.
            ``(2) Report.--Not later than 5 years after the effective 
        date of final regulations issued pursuant to this section, the 
        Comptroller General of the United States shall prepare and 
        submit to Congress a report containing the study described in 
        paragraph (1).'';
            (3) in subsection (k)(2)--
                    (A) by redesignating subparagraphs (A) through (E) 
                as subparagraphs (B) through (F), respectively; and
                    (B) by inserting before subparagraph (B) (as so 
                redesignated) the following subparagraph:
                    ``(A) The term `discrimination' includes a contract 
                provision, a limitation on supply, or other measure 
                which has the effect of providing United States 
                pharmacists, wholesalers, or consumers access to 
                covered products on terms or conditions that are less 
                favorable than the terms or conditions provided to any 
                foreign purchaser of such products.'';
            (4) by striking subsection (m); and
            (5) by inserting after subsection (l) the following 
        subsection:
    ``(m) Funding.--For the purpose of carrying out this section, there 
are authorized to be appropriated such sums as may be necessary for 
fiscal year 2002 and each subsequent fiscal year.''.
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