I 

109TH CONGRESS 

1ST SESSION H. R. 563

To amend part D of title XVIII of the Social Security Act to require 

the Secretary of Health and Human Services to negotiate and disclose 

lowest possible prices for prescription drug prices for Medicare beneficiaries, and, with respect to the Federal Food, Drug, and Cosmetic 

Act, to provide waivers that permit such beneficiaries to import prescription drugs from Canada. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 2, 2005

Mr. LYNCH introduced the following bill; which was referred to the Committee 

on Energy and Commerce, and in addition to the Committee on Ways 

and Means, for a period to be subsequently determined by the Speaker, 

in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 

A BILL

To amend part D of title XVIII of the Social Security 

Act to require the Secretary of Health and Human Services to negotiate and disclose lowest possible prices for 

prescription drug prices for Medicare beneficiaries, and, 

with respect to the Federal Food, Drug, and Cosmetic 

Act, to provide waivers that permit such beneficiaries 

to import 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,
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Prescription Drug Af3 fordability Act of 2005’’. 

4 SEC. 2. NEGOTIATION AND DISCLOSURE OF LOWEST POS5 SIBLE PRICES FOR PRESCRIPTION DRUGS 

6 UNDER MEDICARE. 

7 Section 1860D–11 of the Social Security Act (42 

8 U.S.C. 1395w–111) is amended by striking subsection (i) 

9 (relating to noninterference) and by inserting the fol10 lowing: 

11 ‘‘(i) NEGOTIATION AND DISCLOSURE OF BEST

12 PRICES.—

13 ‘‘(1) NEGOTIATION.—In order to ensure that 

14 beneficiaries enrolled under prescription drug plans 

15 and MA–PD plans pay the lowest possible price, the 

16 Secretary shall have and exercise authority similar 

17 to that of the Secretary of Veterans Affairs, the Sec18 retary of Defense, and the heads of other Federal 

19 agencies and departments that purchase prescription 

20 drugs in bulk to negotiate contracts with manufac21 turers of covered part D drugs, consistent with the 

22 requirements and in furtherance of the goals of pro23 viding quality care and containing costs under this 

24 part. In exercising such authority, the Secretary 

25 shall negotiate the best possible prices for such 

26 drugs. 
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1 ‘‘(2) DISCLOSURE.—The Secretary shall widely 

2 disseminate information on the prices for covered 

3 part D drugs negotiated under paragraph (1).’’. 

4 SEC. 3. MEDICARE BENEFICIARIES; WAIVER REQUIREMENT 

5 FOR PERSONAL IMPORTATION OF PRESCRIP6 TION DRUGS FROM CANADA. 

7 (a) IN GENERAL.— With respect to the importation 

8 by Medicare beneficiaries of prescription drugs from Can9 ada, the Secretary of Health and Human Services, acting 

10 through the Commissioner of Food and Drugs, shall in 

11 accordance with this section establish by regulation a 

12 waiver of prohibitions under the Federal Food, Drug, and 

13 Cosmetic Act that apply to the importation of drugs. Such 

14 a waiver shall permit such a beneficiary to import into 

15 the United States any prescription drug that—

16 (1) is imported from Canada for personal use 

17 by the beneficiary (not for resale); 

18 (2) is approved by the Secretary under section 

19 505 of such Act, is manufactured in an establish20 ment registered with the Secretary under section 

21 510 of such Act, and is not a controlled substance 

22 in schedule I, II, or III under section 202(c) of the 

23 Controlled Substances Act; 

24 (3) is imported from a Canadian pharmacy that 

25 has submitted to the Secretary a registration that 
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1 identifies the pharmacy and provides documentation 

2 that the pharmacy is licensed in Canada; 

3 (4) is imported in a quantity that does not (for 

4 that instance of importation) exceed a 90-day sup5 ply; 

6 (5) at the time of importation, is accompanied 

7 by a copy of a valid prescription for the drug for the 

8 beneficiary, issued in the United States by a practi9 tioner in accordance with section 503(b) of the Fed10 eral Food, Drug, and Cosmetic Act, or is accom11 panied by documentation that verifies the issuance 

12 of such a prescription for the beneficiary; 

13 (6) is in the form of a final finished dosage; 

14 and 

15 (7) is imported under such other conditions as 

16 the Secretary determines to be necessary to ensure 

17 public safety. 

18 (b) DEFINITIONS.—For purposes of subsection (a): 

19 (1) The term ‘‘Medicare beneficiary’’ means an 

20 individual who is entitled to benefits under, or en21 rolled in, part A of title XVIII of the Social Security 

22 Act, enrolled under part B of such title, or both. 

23 (2) The term ‘‘Secretary’’ means the Secretary 

24 of Health and Human Services.

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