[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5975 Introduced in House (IH)]








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 research to develop valid scientific evidence regarding 
 comparative clinical effectiveness, outcomes, and appropriateness of 
  prescription drugs, medical 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. Gutknecht) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
     To require the Agency for Healthcare Research and Quality, in 
consultation with the Director of the National Institutes of Health, to 
    conduct research to develop valid scientific evidence regarding 
 comparative clinical effectiveness, outcomes, and appropriateness of 
  prescription drugs, medical devices, and procedures, 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 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 
        scientific evidence regarding comparative clinical 
        effectiveness, outcomes, and appropriateness of prescription 
        drugs, medical devices, and procedures. In conducting or 
        supporting such research, particular consideration 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 procedures. In conducting or supporting 
                such reviews, particular consideration shall be given 
                to treatments that involve high volume, high cost, or 
                high risk to patients.
                    (B) Better clinician and patient information on 
                safety.--Within 12 months of the date of the enactment 
                of this Act, the Secretary of Health and Human 
                Services, in consultation with the Director of the 
                Agency for Healthcare Research and Quality, the 
                Commissioner of Food and Drugs, and the Director of the 
                National Institutes of Health, shall develop a 
                coordinated plan for research on the most appropriate 
                methods for measuring and comparing adverse events 
                associated with pharmaceuticals and other medical and 
                surgical treatments so that clinicians and patients can 
                evaluate the comparative safety as well as the 
                comparative 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 analyses conducted 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.
    (c) Reports for Practitioners.--As soon as possible, 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 Research and Quality shall--
            (1) prepare a report on the results of such systemic review 
        for the purpose of informing health care practitioners; and
            (2) identify treatment options for which comparative 
        clinical effectiveness judgments could not be reached due to 
        insufficient evidence and make such identifications available 
        to the Director of the National Institutes of Health and other 
        entities funding research.
    (d) Information for Patients.--The Director of the Agency for 
Healthcare Research and Quality shall create a version of each report 
prepared for practitioners under subsection (c)(1) in a form that is 
easily understood by the individuals receiving the treatments involved.
    (e) Availability.--The Director of the Agency for Healthcare 
Research and Quality--
            (1) shall publish on the Agency's Internet site, and 
        through other means that will facilitate access by 
        practitioners, each report prepared under subsection (b), (c), 
        or (d); and
            (2) make the information in such reports available to the 
        public through easily accessible and searchable electronic 
        mechanisms, and in hard copy formats as appropriate.
    (f) Accountability.--In carrying out this subsection, the Secretary 
of Health and Human Services shall implement activities in a manner 
that makes publicly available all scientific evidence relied upon and 
the methodologies employed, provided such evidence and method are not 
protected from public disclosure by section 1905 of title 18, United 
States Code, or other applicable law, so that the results of the 
research, analyses, or syntheses involved can be evaluated and 
replicated.
    (g) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated to the Agency for Healthcare 
Research and Quality and the National Institutes of Health $100,000,000 
for fiscal year 2007 and such sums as may be necessary for fiscal year 
2008 and each subsequent fiscal year.
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