[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2356 Introduced in House (IH)]






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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

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 EFFECTIVENESS 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 include clinical research, to develop valid 
        scientific evidence 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 condition.
            (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 section, shall use evidence-based 
                practice centers to conduct studies or other analyses 
                of 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 condition.
                    (B) Safety.--In any analysis of comparative 
                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 Director 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 Director 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 analyses 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 Services.
            (4) The Secretary of Veterans Affairs.
            (5) The Administrator of the Centers for Medicare & 
        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 possible, 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 practitioners; and
            (2) transmit the report to the Director of the National 
        Institutes of Health.
    (e) NIH Internet Site.--The Director of the National Institutes of 
Health shall publish on the Institutes' Internet site, and through 
other means that will facilitate access by practitioners, each report 
prepared under subsection (c) or (d) by the Director of the Agency for 
Healthcare Research and Quality.
    (f) Evidence.--In carrying out this section, the Directors of the 
National Institutes of Health and the Agency for Healthcare Research 
and Quality shall consider only methodologically sound studies, giving 
preference to studies for which the Directors have access to sufficient 
underlying 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 appropriated 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 appropriated to the 
        Agency for Healthcare Research and Quality to carry out this 
        section $25,000,000 for fiscal year 2004, and such sums as may 
        be necessary for fiscal years thereafter.
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