SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Prescription Drug 
Comparative Effectiveness Act of 2003’’. 
SEC. 2. NIH RESEARCH AND AHRQ STUDY ON EFFECTIVE-
NESS OF CERTAIN PRESCRIPTION DRUGS. 
(a) IN GENERAL.—
(1) RESEARCH BY NIH.—The Director of the 
National Institutes of Health, in coordination with 
the Director of the Agency for Healthcare Research 
and Quality, shall conduct research, which may in-
clude clinical research, to develop valid scientific evi-
dence regarding the comparative effectiveness, cost-
effectiveness, and, where appropriate, comparative 
safety of covered prescription drugs relative to other 
drugs and treatments for the same disease or condi-
tion. 
(2) ANALYSIS BY AHRQ.—
(A) IN
GENERAL.—The Director of the 
Agency for Healthcare Research and Quality, 
taking into consideration the research of the 
National Institutes of Health under this sec-
tion, shall use evidence-based practice centers to 
conduct studies or other analyses of the com-
parative effectiveness, cost-effectiveness, and, 
where appropriate, comparative safety of cov-
ered prescription drugs relative to other drugs
and treatments for the same disease or condi-
tion. 
(B) SAFETY.—In any analysis of compara-
tive effectiveness or cost-effectiveness under this 
subparagraph, the Director of the Agency for 
Healthcare Research and Quality shall include 
a discussion of available information on relative 
safety. 
(3) STANDARDS.—The Director of the Agency 
for Healthcare Research and Quality, in consultation 
with the Commissioner of Food and Drugs, the Di-
rector of the National Institutes of Health, and 
stakeholders, shall develop standards for the design 
and conduct of cost-effectiveness studies under this 
subsection. 
(b) COVERED PRESCRIPTION DRUGS.—For purposes 
of this section, the term ‘‘covered prescription drugs’’ 
means prescription drugs that, as determined by the Di-
rector of the Agency for Healthcare Research and Quality 
in consultation with the Administrator of the Centers for 
Medicare & Medicaid Services, account for high levels of 
expenditures or use by individuals in federally funded 
health programs, including Medicare and Medicaid. 
(c) ANNUAL REPORT.—Each year the Director of the 
Agency for Healthcare Research and Quality shall prepare
a report on the results of the research, studies, and anal-
yses conducted by the National Institutes of Health and 
the Agency for Healthcare Research and Quality under 
this section and submit the report to the following: 
(1) The Congress. 
(2) The Secretary of Defense. 
(3) The Secretary of Health and Human Serv-
ices. 
(4) The Secretary of Veterans Affairs. 
(5) The Administrator of the Centers for Medi-
care & Medicaid Services. 
(6) The Director of the Indian Health Service. 
(7) The Director of the National Institutes of 
Health. 
(8) The Director of the Office of Personnel 
Management. 
(d) REPORTS FOR PRACTITIONERS.—As soon as pos-
sible, but not later than a year after the completion of 
any study pursuant to subsection (a)(2), the Director of 
the Agency for Healthcare Research and Quality shall—
(1) prepare a report on the results of such 
study for the purpose of informing health care prac-
titioners; and 
(2) transmit the report to the Director of the 
National Institutes of Health.
(e) NIH INTERNET SITE.—The Director of the Na-
tional Institutes of Health shall publish on the Institutes’ 
Internet site, and through other means that will facilitate 
access by practitioners, each report prepared under sub-
section (c) or (d) by the Director of the Agency for 
Healthcare Research and Quality. 
(f) EVIDENCE.—In carrying out this section, the Di-
rectors of the National Institutes of Health and the Agen-
cy for Healthcare Research and Quality shall consider only 
methodologically sound studies, giving preference to stud-
ies for which the Directors have access to sufficient under-
lying data and analysis to address any significant concerns 
about methodology or the reliability of data. 
(g) AUTHORIZATIONS OF APPROPRIATIONS.—
(1) NIH.—There are authorized to be appro-
priated to the National Institutes of Health to carry 
out this section $50,000,000 for fiscal year 2004, 
and such sums as may be necessary for fiscal years 
thereafter. 
(2) AHRQ.—There are authorized to be appro-
priated to the Agency for Healthcare Research and 
Quality to carry out this section $25,000,000 for fis-
cal year 2004, and such sums as may be necessary 
for fiscal years thereafter.
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