I
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. ABER-
CROMBIE, Mr. DEFAZIO, Mr. HILLIARD, Mr. FILNER, Mr. OLVER, Mr.
LAFALCE, and Mr. HINCHEY) introduced the following bill; which was re-
ferred 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 Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Prescription Re-
importation, Improvement, Correction, and Enhancement
Act’’.
SEC. 2. AMENDMENTS TO PROGRAM FOR IMPORTATION OF
CERTAIN PRESCRIPTION DRUGS BY PHAR-
MACISTS 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 in-
serting 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 man-
ufacturer of the product;
‘‘(B) shall require that, if such tests are
conducted by the importer, information needed
to authenticate the product being tested be sup-
plied 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 ap-
proved for the product under section 505, notwith-
standing any other provision of law.
‘‘(f) DISCRETION OF SECRETARY REGARDING TEST-
ING.—The Secretary may waive or modify testing require-
ments described in subsection (d) if, with respect to spe-
cific countries or specific distribution chains, the Secretary
has entered into agreements or otherwise approved ar-
rangements that the Secretary determines ensure that the
covered products involved are not adulterated or in viola-
tion of section 505.’’;
(2) by striking subsections (h) and (i) and in-
serting the following subsections:
‘‘(h) PROHIBITED AGREEMENTS; NONDISCRIMINA-
TION.—
‘‘(1) PROHIBITED AGREEMENTS.—No manufac-
turer 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 discrimi-
nate against, or cause other persons to discriminate
against, United States pharmacists, wholesalers, or
consumers regarding the sale or distribution of cov-
ered 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 consider-
ation the information received under subsection (a).
In conducting such study, the Comptroller General
shall—
‘‘(A) evaluate importers’ compliance with
regulations, determine the number of ship-
ments, if any, permitted under this section that
have been determined to be counterfeit, mis-
branded, or adulterated; and
‘‘(B) consult with the United States Trade
Representative and United States Patent and
Trademark Office to evaluate the effect of im-
portations 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 re-
port 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 subpara-
graph:
‘‘(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 con-
sumers access to covered products on terms or
conditions that are less favorable than the
terms or conditions provided to any foreign pur-
chaser of such products.’’;
(4) by striking subsection (m); and
(5) by inserting after subsection (l) the fol-
lowing 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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