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 bene-
ficiaries, and, with respect to the Federal Food, Drug, and Cosmetic 
Act, to provide waivers that permit such beneficiaries to import prescrip-
tion 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 juris-
diction 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 Serv-
ices 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.
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 Drug Af-
fordability Act of 2005’’. 
SEC. 2. NEGOTIATION AND DISCLOSURE OF LOWEST POS-
SIBLE PRICES FOR PRESCRIPTION DRUGS 
UNDER MEDICARE. 
Section 1860D–11 of the Social Security Act (42 
U.S.C. 1395w–111) is amended by striking subsection (i) 
(relating to noninterference) and by inserting the fol-
lowing: 
‘‘(i) NEGOTIATION
AND
DISCLOSURE
OF
BEST 
PRICES.—
‘‘(1) NEGOTIATION.—In order to ensure that 
beneficiaries enrolled under prescription drug plans 
and MA–PD plans pay the lowest possible price, the 
Secretary shall have and exercise authority similar 
to that of the Secretary of Veterans Affairs, the Sec-
retary of Defense, and the heads of other Federal 
agencies and departments that purchase prescription 
drugs in bulk to negotiate contracts with manufac-
turers of covered part D drugs, consistent with the 
requirements and in furtherance of the goals of pro-
viding quality care and containing costs under this 
part. In exercising such authority, the Secretary 
shall negotiate the best possible prices for such 
drugs.
‘‘(2) DISCLOSURE.—The Secretary shall widely 
disseminate information on the prices for covered 
part D drugs negotiated under paragraph (1).’’. 
SEC. 3. MEDICARE BENEFICIARIES; WAIVER REQUIREMENT 
FOR PERSONAL IMPORTATION OF PRESCRIP-
TION DRUGS FROM CANADA. 
(a) IN GENERAL.— With respect to the importation 
by Medicare beneficiaries of prescription drugs from Can-
ada, the Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall in 
accordance with this section establish by regulation a 
waiver of prohibitions under the Federal Food, Drug, and 
Cosmetic Act that apply to the importation of drugs. Such 
a waiver shall permit such a beneficiary to import into 
the United States any prescription drug that—
(1) is imported from Canada for personal use 
by the beneficiary (not for resale); 
(2) is approved by the Secretary under section 
505 of such Act, is manufactured in an establish-
ment registered with the Secretary under section 
510 of such Act, and is not a controlled substance 
in schedule I, II, or III under section 202(c) of the 
Controlled Substances Act; 
(3) is imported from a Canadian pharmacy that 
has submitted to the Secretary a registration that
identifies the pharmacy and provides documentation 
that the pharmacy is licensed in Canada; 
(4) is imported in a quantity that does not (for 
that instance of importation) exceed a 90-day sup-
ply; 
(5) at the time of importation, is accompanied 
by a copy of a valid prescription for the drug for the 
beneficiary, issued in the United States by a practi-
tioner in accordance with section 503(b) of the Fed-
eral Food, Drug, and Cosmetic Act, or is accom-
panied by documentation that verifies the issuance 
of such a prescription for the beneficiary; 
(6) is in the form of a final finished dosage; 
and 
(7) is imported under such other conditions as 
the Secretary determines to be necessary to ensure 
public safety. 
(b) DEFINITIONS.—For purposes of subsection (a): 
(1) The term ‘‘Medicare beneficiary’’ means an 
individual who is entitled to benefits under, or en-
rolled in, part A of title XVIII of the Social Security 
Act, enrolled under part B of such title, or both. 
(2) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services.
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