I 
109TH CONGRESS 
2D SESSION 
H. R. 5975 
To require the Agency for Healthcare Research and Quality, in consultation 
with the Director of the National Institutes of Health, to conduct re-
search to develop valid scientific evidence regarding comparative clinical 
effectiveness, outcomes, and appropriateness of prescription drugs, med-
ical devices, and procedures, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 28, 2006 
Mr. ALLEN (for himself, Mrs. EMERSON, Mr. WAXMAN, Mr. EHLERS, Mr. 
BERRY, Mr. BURTON of Indiana, Mr. BROWN of Ohio, and Mr. GUT-
KNECHT) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce 
A BILL 
To require the Agency for Healthcare Research and Quality, 
in consultation with the Director of the National Insti-
tutes of Health, to conduct research to develop valid 
scientific evidence regarding comparative clinical effec-
tiveness, outcomes, and appropriateness of prescription 
drugs, medical devices, and procedures, and for other 
purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Prescription Drug 
Comparative Effectiveness Act of 2006’’. 
SEC. 2. RESEARCH AND STUDY ON EFFECTIVENESS OF 
CERTAIN PRESCRIPTION DRUGS. 
(a) IN GENERAL.— 
(1) RESEARCH.—The Director of the Agency 
for Healthcare Research and Quality, in consultation 
with the Director of the National Institutes of 
Health, shall conduct or support research, which 
may include clinical research, to develop valid sci-
entific evidence regarding comparative clinical effec-
tiveness, outcomes, and appropriateness of prescrip-
tion drugs, medical devices, and procedures. In con-
ducting or supporting such research, particular con-
sideration shall be given to treatments that involve 
high volume, high cost, or high risk to patients. 
(2) SYSTEMATIC REVIEWS.— 
(A) IN
GENERAL.—The Director of the 
Agency for Healthcare Research and Quality 
shall conduct or support systematic reviews of 
existing evidence regarding comparative clinical 
effectiveness, outcomes, and appropriateness of 
prescription drugs, medical devices, and proce-
dures. In conducting or supporting such re-
views, particular consideration shall be given to 
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treatments that involve high volume, high cost, 
or high risk to patients. 
(B) BETTER CLINICIAN AND PATIENT IN-
FORMATION ON SAFETY.—Within 12 months of 
the date of the enactment of this Act, the Sec-
retary of Health and Human Services, in con-
sultation with the Director of the Agency for 
Healthcare Research and Quality, the Commis-
sioner of Food and Drugs, and the Director of 
the National Institutes of Health, shall develop 
a coordinated plan for research on the most ap-
propriate methods for measuring and com-
paring adverse events associated with pharma-
ceuticals and other medical and surgical treat-
ments so that clinicians and patients can evalu-
ate the comparative safety as well as the com-
parative clinical effectiveness of the alternative 
treatment options. 
(b) 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 under this section and submit the report 
to the following: 
(1) The Congress. 
(2) The Secretary of Defense. 
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(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. 
(c) REPORTS FOR PRACTITIONERS.—As soon as pos-
sible, but not later than a year after the completion of 
any systemic review conducted pursuant to subsection 
(a)(2), the Director of the Agency for Healthcare Re-
search and Quality shall— 
(1) prepare a report on the results of such sys-
temic review for the purpose of informing health 
care practitioners; and 
(2) identify treatment options for which com-
parative clinical effectiveness judgments could not be 
reached due to insufficient evidence and make such 
identifications available to the Director of the Na-
tional Institutes of Health and other entities funding 
research. 
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