H.R. 2356House108th Congress (2003-2005)In Committee

Prescription Drug Comparative Effectiveness Act of 2003

Introduced June 5, 2003

Legislative Activity

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2 earlier actions
HouseCommittee Latest Action

Referred to the Subcommittee on Health.

June 11, 2003

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HouseIntro Referral

Introduced in House

June 5, 2003

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

June 5, 2003

HouseCommittee

Referred to the Subcommittee on Health.

June 11, 2003

Floor Debate

24 members

What members said about H.R. 2356 on the floor

11 Republicans12 Democrats1 Independent
Marcy Kaptur
Rep. Marcy KapturD-OH-9 · Jul 14, 2004

Mr. Speaker, I thank the gentleman from Ohio, and I doubt anyone can hold a candle to him relative to trade. Mr. Speaker, I rise in opposition to this trade proposal, in a way reluctantly. I had held…

Philip M. Crane
Rep. Philip M. CraneR-IL-8 · Jul 14, 2004

Mr. Speaker, I reserve the balance of my time. Mr. Speaker, I yield myself such time as I may consume. I want to remind my colleague that we can get into the debate on reimportation of drugs at some…

Fortney Pete Stark
Rep. Fortney Pete StarkD-CA-13 · Jul 14, 2004

Mr. Speaker, I yield 30 minutes of my time to the gentleman from New York (Mr. Crowley), and I ask unanimous consent that he be allowed to yield such time as he sees fit. Mr. Speaker, I yield myself…

David Dreier
Rep. David DreierR-CA-26 · Jul 14, 2004

Mr. Speaker, I rise in strong support of this legislation. I would like to take a few minutes to first follow up on the discussion that we had at the opening of the rules debate this morning on the…

Thomas H. Allen
Rep. Thomas H. AllenD-ME-1 · Jul 14, 2004

Mr. Speaker, I rise in support of the U.S.-Australia Free Trade Agreement, but with strong reservations about the pharmaceutical provisions. Australia is the 12th largest foreign market for the State…

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Sander M. Levin
Rep. Sander M. LevinD-MI-12 · Jul 14, 2004

Mr. Speaker, it is my pleasure to yield 2 minutes to the gentlewoman from Guam (Mr. Bordallo), a very capable Congresswoman. Mr. Speaker, it is my privilege and pleasure to yield 2 minutes to the…

Sherrod Brown
Rep. Sherrod BrownD-OH-13 · Jul 14, 2004

Mr. Speaker, I yield myself such time as I may consume. It has been a really good year for the drug industry. The pharmaceutical industry is at it again in this body, attempting to undermine U.S.…

Joseph Crowley
Rep. Joseph CrowleyD-NY-7 · Jul 14, 2004

Mr. Speaker, I yield 3 minutes to the gentleman from Maryland (Mr. Cardin). Mr. Speaker, I yield myself 3\1/2\ minutes. Mr. Speaker, I rise today in strong support of the free trade agreement between…

Doug Bereuter
Rep. Doug BereuterR-NE-1 · Jul 14, 2004

Mr. Speaker, this Member rises today to express his support for the United States-Australia Free Trade Implementation Act (H.R. 4759). This Member would like to thank the distinguished gentleman from…

Gil Gutknecht
Rep. Gil GutknechtR-MN-1 · Jul 14, 2004

Mr. Speaker, I certainly appreciate that the U.S. Trade Representative has addressed the important concerns related to agriculture in this free trade agreement. Agriculture is important to my…

Bernard Sanders
Rep. Bernard SandersI-VT · Jul 14, 2004

Mr. Speaker, I thank my good friend, the gentleman from Ohio (Mr. Brown), for yielding me time. I rise in strong opposition to this agreement. It seems to me that before we rush into yet another free…

Tammy Baldwin
Rep. Tammy BaldwinD-WI-2 · Jul 14, 2004

Mr. Speaker, I rise in opposition to this legislation. The Australian Free Trade Agreement has been crafted in a way that repeats the flaws and weaknesses of previous agreements such as NAFTA.…

William M. Thomas
Rep. William M. ThomasR-CA-22 · Jul 14, 2004

Mr. Speaker, pursuant to House Resolution 712, I call up the bill (H.R. 4759) to implement the United States-Australia Free Trade Agreement, and ask for its immediate consideration. Mr. Speaker, I…

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Jim Kolbe
Rep. Jim KolbeR-AZ-8 · Jul 14, 2004

Mr. Speaker, I thank the gentleman for yielding me time. Let me begin by saying to the gentleman from Illinois that I want to congratulate him and thank him for his leadership in the area of trade.…

Gene Green
Rep. Gene GreenD-TX-29 · Jul 14, 2004

Mr. Speaker, I rise in support of the U.S.- Australia Free Trade Agreement and this bill we are considering today to implement it. With few exceptions, I have historically opposed our free trade…

Jennifer Dunn
Rep. Jennifer DunnR-WA-8 · Jul 14, 2004

Mr. Speaker, I rise in support of this historic free trade agreement with Australia. Australia has been a true friend and ally. They have been there when it counted the most, on the shores of…

Peter A. DeFazio
Rep. Peter A. DeFazioD-OR-4 · Jul 14, 2004

Mr. Speaker, Australia is exactly the type of nation we should seek trade agreements with, but not with a Xerox of our old and failed policies under fast track, with no amendments allowed here on the…

Rob Portman
Rep. Rob PortmanR-OH-2 · Jul 14, 2004

Mr. Speaker, I thank the gentleman for yielding me time, and I appreciate his clarification and also the clarification of the gentleman from New York (Mr. Crowley) as this legislation before us…

Benjamin L. Cardin
Rep. Benjamin L. CardinD-MD-3 · Jul 14, 2004

Mr. Speaker, let me thank my friend from New York for yielding me this time. I rise in support of this free trade agreement and urge my colleagues to support it. This is a bilateral free trade…

John A. Boehner
Rep. John A. BoehnerR-OH-8 · Jul 14, 2004

Mr. Speaker, I rise in strong support of this measure, which demonstrates, once again, the unmatched value of trade liberalization and the shared benefits of free trade agreements. Over the last…

Phil English
Rep. Phil EnglishR-PA-3 · Jul 14, 2004

Mr. Speaker, today, the House is considering, I think, landmark trade legislation by considering a free trade agreement with our close ally and trading partner, Australia. As a member of the…

Randy (Duke) Cunningham
Rep. Randy (Duke) CunninghamR-CA-50 · Jul 14, 2004

Mr. Speaker, I rise in full support of this agreement. First of all, many folks in the military that have traveled around the world, no matter where I have gone, where we needed allies, Australia has…

Bob Etheridge
Rep. Bob EtheridgeD-NC-2 · Jul 14, 2004

Mr. Speaker, I rise today to announce my support for H.R. 4759, legislation implementing a free trade agreement with the nation of Australia. Australia represents the world's 15th largest economy and…

Rosa L. DeLauro
Rep. Rosa L. DeLauroD-CT-3 · Jul 14, 2004

Mr. Speaker, the Australia Free Trade Agreement is for the most part a good agreement with a strong U.S. ally. But because it is becoming increasingly clear that the reimportation of prescription…

Bill Text

Latest available legislative text

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Latest
Introduced in HouseIssued June 5, 2003
        [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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