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) 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 prescription drugs from 

Canada.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Preserving Access to 

5 Safe, Affordable Canadian Medicines Act of 2003’’. 
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1 SEC. 2. FINDINGS. 

2 The Congress finds as follows: 

3 (1) Prescription drug manufacturers charge 

4 substantially more for their products in the United 

5 States than in Canada. 

6 (2) Many Americans cannot afford the higher 

7 U.S. prices and are forced to either go without their 

8 needed medications or sacrifice other necessities of 

9 life in order to afford them. 

10 (3) Increasingly, Americans have turned to the 

11 Canadian market to purchase their needed medica12 tions at substantially lower prices and the Food and 

13 Drug Administration now estimates that two million 

14 parcels containing prescription drugs enter the U.S. 

15 for personal use each year. 

16 (4) The Congressional Research Service has 

17 confirmed that Canada has a drug approval and dis18 tribution system comparable to that of the United 

19 States. 

20 (5) Drug manufacturers are trying to cut off 

21 the supply of prescription drugs accessed by U.S. 

22 consumers on the Canadian market in blatant dis23 regard of the health consequences for Americans. 
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1 SEC. 3. NONDISCRIMINATION AGAINST IMPORTS OF PRE2 SCRIPTION DRUGS. 

3 (a) IN GENERAL.—Chapter VIII of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) 

5 is amended—

6 (1) in section 801(d)(1), by striking ‘‘section 

7 804,’’ and inserting ‘‘sections 804 and 805,’’; and 

8 (2) by adding at the end the following: 

9 ‘‘PROHIBITION AGAINST DISCRIMINATION AGAINST

10 IMPORTS

11 ‘‘SEC. 805. (a) REGULATIONS.—The Secretary, after 

12 consultation with the United States Trade Representative 

13 and the Commissioner of Customs, shall promulgate regu14 lations prohibiting manufacturers of prescription medica15 tions from taking actions that discriminate against, or 

16 cause other persons to discriminate against, United States 

17 consumers regarding the purchase of prescription medica18 tions from Canadian pharmacies. 

19 ‘‘(b) NONDISCRIMINATION.—No manufacturer of a 

20 prescription medication may take actions that discrimi21 nate against, or cause other persons to discriminate 

22 against, United States consumers regarding the purchase 

23 of a prescription medication from Canadian pharmacies. 

24 ‘‘(c) DEFINITION.—For purposes of this section, the 

25 term ‘discrimination’ means a contract provision, a limita26 tion on supply, or other measure which has the effect of 
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1 providing U.S. consumers access to prescription medica2 tions on terms or conditions that are less favorable than 

3 the terms or conditions provided to any foreign purchaser 

4 of such products, or otherwise has the effect of restricting 

5 or reducing access by United States consumers to a pre6 scription medication from Canadian pharmacies.’’. 

7 (b) PROHIBITED ACT.—Section 301 of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend9 ed by adding at the end the following: 

10 ‘‘(hh) Discrimination by a manufacturer in violation 

11 of section 805.’’. 

12 (c) CIVIL PENALTIES.—Section 303 of the Federal 

13 Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend14 ed by adding at the end the following subsection: 

15 ‘‘(h)(1) Any manufacturer of a prescription medica16 tion that knowingly violates section 805(b) shall be liable 

17 to the United States for a civil penalty in an amount not 

18 to exceed $1,000,000. 

19 ‘‘(2) Paragraphs (3) through (5) of subsection (g) 

20 apply with respect to a civil penalty under paragraph (1) 

21 of this subsection to the same extent and in the same man22 ner as such paragraphs (3) through (5) apply with respect 

23 to a civil penalty under paragraph (1) or (2) of subsection 

24 (g).’’.

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