[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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