I 
108TH CONGRESS 
1ST SESSION 
H. R. 847
To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
importation of prescription drugs from Canada. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 13, 2003
Mr. SANDERS (for himself, Mr. BURTON of Indiana, Ms. DELAURO, Mr. 
CROWLEY, Mrs. EMERSON, Mr. BERRY, Ms. KAPTUR, Mr. MCGOVERN, 
Mr. DEFAZIO, Mr. TIERNEY, Mr. DOGGETT, Mr. STARK, Ms. WOOLSEY, 
Ms. LEE, Mr. OLVER, Ms. SOLIS, Mr. EVANS, Mr. OWENS, Mr. 
SERRANO, Mr. ABERCROMBIE, Mr. NADLER, Ms. CORRINE BROWN of 
Florida, Mr. SABO, Mr. JACKSON of Illinois, Ms. VELA´ZQUEZ, Mr. 
CAPUANO, Mr. HINCHEY, Mr. KUCINICH, Mr. MEEHAN, Mr. LEVIN, Mr. 
PALLONE, Mr. BROWN of Ohio, Ms. BALDWIN, and Mr. FILNER) intro-
duced 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 prescription drugs from 
Canada.
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 ‘‘Preserving Access to 
Safe, Affordable Canadian Medicines Act of 2003’’.
SEC. 2. FINDINGS. 
The Congress finds as follows: 
(1) Prescription drug manufacturers charge 
substantially more for their products in the United 
States than in Canada. 
(2) Many Americans cannot afford the higher 
U.S. prices and are forced to either go without their 
needed medications or sacrifice other necessities of 
life in order to afford them. 
(3) Increasingly, Americans have turned to the 
Canadian market to purchase their needed medica-
tions at substantially lower prices and the Food and 
Drug Administration now estimates that two million 
parcels containing prescription drugs enter the U.S. 
for personal use each year. 
(4) The Congressional Research Service has 
confirmed that Canada has a drug approval and dis-
tribution system comparable to that of the United 
States. 
(5) Drug manufacturers are trying to cut off 
the supply of prescription drugs accessed by U.S. 
consumers on the Canadian market in blatant dis-
regard of the health consequences for Americans.
SEC. 3. NONDISCRIMINATION AGAINST IMPORTS OF PRE-
SCRIPTION DRUGS. 
(a) IN GENERAL.—Chapter VIII of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) 
is amended—
(1) in section 801(d)(1), by striking ‘‘section 
804,’’ and inserting ‘‘sections 804 and 805,’’; and 
(2) by adding at the end the following: 
‘‘PROHIBITION AGAINST DISCRIMINATION AGAINST 
IMPORTS 
‘‘SEC. 805. (a) REGULATIONS.—The Secretary, after 
consultation with the United States Trade Representative 
and the Commissioner of Customs, shall promulgate regu-
lations prohibiting manufacturers of prescription medica-
tions from taking actions that discriminate against, or 
cause other persons to discriminate against, United States 
consumers regarding the purchase of prescription medica-
tions from Canadian pharmacies. 
‘‘(b) NONDISCRIMINATION.—No manufacturer of a 
prescription medication may take actions that discrimi-
nate against, or cause other persons to discriminate 
against, United States consumers regarding the purchase 
of a prescription medication from Canadian pharmacies. 
‘‘(c) DEFINITION.—For purposes of this section, the 
term ‘discrimination’ means a contract provision, a limita-
tion on supply, or other measure which has the effect of
providing U.S. consumers access to prescription medica-
tions on terms or conditions that are less favorable than 
the terms or conditions provided to any foreign purchaser 
of such products, or otherwise has the effect of restricting 
or reducing access by United States consumers to a pre-
scription medication from Canadian pharmacies.’’. 
(b) PROHIBITED ACT.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following: 
‘‘(hh) Discrimination by a manufacturer in violation 
of section 805.’’. 
(c) CIVIL PENALTIES.—Section 303 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend-
ed by adding at the end the following subsection: 
‘‘(h)(1) Any manufacturer of a prescription medica-
tion that knowingly violates section 805(b) shall be liable 
to the United States for a civil penalty in an amount not 
to exceed $1,000,000. 
‘‘(2) Paragraphs (3) through (5) of subsection (g) 
apply with respect to a civil penalty under paragraph (1) 
of this subsection to the same extent and in the same man-
ner as such paragraphs (3) through (5) apply with respect 
to a civil penalty under paragraph (1) or (2) of subsection 
(g).’’.
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