I 

108TH CONGRESS 

1ST SESSION H. R. 2356

To require the National Institutes of Health to conduct research, and the 

Agency for Healthcare Research and Quality to conduct studies, on 

the comparative effectiveness and cost-effectiveness of prescription drugs 

that account for high levels of expenditures or use by individuals in 

federally funded health programs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 5, 2003

Mr. ALLEN (for himself, Mrs. EMERSON, Mr. BERRY, Mr. BEREUTER, Mr. 

WAXMAN, Mr. BURTON of Indiana, Mr. DAVIS of Florida, Mr. GUTKNECHT, Mr. SNYDER, Mrs. BONO, Mr. COOPER, and Mr. WAMP) introduced the following bill; which was referred to the Committee on Energy 

and Commerce 

A BILL

To require the National Institutes of Health to conduct research, and the Agency for Healthcare Research and 

Quality to conduct studies, on the comparative effectiveness and cost-effectiveness of prescription drugs that account for high levels of expenditures or use by individuals 

in federally funded health programs, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
2

•HR 2356 IH 

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Prescription Drug 

3 Comparative Effectiveness Act of 2003’’. 

4 SEC. 2. NIH RESEARCH AND AHRQ STUDY ON EFFECTIVE5 NESS OF CERTAIN PRESCRIPTION DRUGS. 

6 (a) IN GENERAL.—

7 (1) RESEARCH BY NIH.—The Director of the 

8 National Institutes of Health, in coordination with 

9 the Director of the Agency for Healthcare Research 

10 and Quality, shall conduct research, which may in11 clude clinical research, to develop valid scientific evi12 dence regarding the comparative effectiveness, cost13 effectiveness, and, where appropriate, comparative 

14 safety of covered prescription drugs relative to other 

15 drugs and treatments for the same disease or condi16 tion. 

17 (2) ANALYSIS BY AHRQ.—

18 (A) IN GENERAL.—The Director of the 

19 Agency for Healthcare Research and Quality, 

20 taking into consideration the research of the 

21 National Institutes of Health under this sec22 tion, shall use evidence-based practice centers to 

23 conduct studies or other analyses of the com24 parative effectiveness, cost-effectiveness, and, 

25 where appropriate, comparative safety of cov26 ered prescription drugs relative to other drugs 
3

•HR 2356 IH 

1 and treatments for the same disease or condi2 tion. 

3 (B) SAFETY.—In any analysis of compara4 tive effectiveness or cost-effectiveness under this 

5 subparagraph, the Director of the Agency for 

6 Healthcare Research and Quality shall include 

7 a discussion of available information on relative 

8 safety. 

9 (3) STANDARDS.—The Director of the Agency 

10 for Healthcare Research and Quality, in consultation 

11 with the Commissioner of Food and Drugs, the Di12 rector of the National Institutes of Health, and 

13 stakeholders, shall develop standards for the design 

14 and conduct of cost-effectiveness studies under this 

15 subsection. 

16 (b) COVERED PRESCRIPTION DRUGS.—For purposes 

17 of this section, the term ‘‘covered prescription drugs’’ 

18 means prescription drugs that, as determined by the Di19 rector of the Agency for Healthcare Research and Quality 

20 in consultation with the Administrator of the Centers for 

21 Medicare & Medicaid Services, account for high levels of 

22 expenditures or use by individuals in federally funded 

23 health programs, including Medicare and Medicaid. 

24 (c) ANNUAL REPORT.—Each year the Director of the 

25 Agency for Healthcare Research and Quality shall prepare 
4

•HR 2356 IH 

1 a report on the results of the research, studies, and anal2 yses conducted by the National Institutes of Health and 

3 the Agency for Healthcare Research and Quality under 

4 this section and submit the report to the following: 

5 (1) The Congress. 

6 (2) The Secretary of Defense. 

7 (3) The Secretary of Health and Human Serv8 ices. 

9 (4) The Secretary of Veterans Affairs. 

10 (5) The Administrator of the Centers for Medi11 care & Medicaid Services. 

12 (6) The Director of the Indian Health Service. 

13 (7) The Director of the National Institutes of 

14 Health. 

15 (8) The Director of the Office of Personnel 

16 Management. 

17 (d) REPORTS FOR PRACTITIONERS.—As soon as pos18 sible, but not later than a year after the completion of 

19 any study pursuant to subsection (a)(2), the Director of 

20 the Agency for Healthcare Research and Quality shall—

21 (1) prepare a report on the results of such 

22 study for the purpose of informing health care prac23 titioners; and 

24 (2) transmit the report to the Director of the 

25 National Institutes of Health. 
5

•HR 2356 IH 

1 (e) NIH INTERNET SITE.—The Director of the Na2 tional Institutes of Health shall publish on the Institutes’ 

3 Internet site, and through other means that will facilitate 

4 access by practitioners, each report prepared under sub5 section (c) or (d) by the Director of the Agency for 

6 Healthcare Research and Quality. 

7 (f) EVIDENCE.—In carrying out this section, the Di8 rectors of the National Institutes of Health and the Agen9 cy for Healthcare Research and Quality shall consider only 

10 methodologically sound studies, giving preference to stud11 ies for which the Directors have access to sufficient under12 lying data and analysis to address any significant concerns 

13 about methodology or the reliability of data. 

14 (g) AUTHORIZATIONS OF APPROPRIATIONS.—

15 (1) NIH.—There are authorized to be appro16 priated to the National Institutes of Health to carry 

17 out this section $50,000,000 for fiscal year 2004, 

18 and such sums as may be necessary for fiscal years 

19 thereafter. 

20 (2) AHRQ.—There are authorized to be appro21 priated to the Agency for Healthcare Research and 

22 Quality to carry out this section $25,000,000 for fis23 cal year 2004, and such sums as may be necessary 

24 for fiscal years thereafter.

Æ