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New Pharmaceutical Drug Pricing Legislation



  This is the text of the new and much more comprehensive Sanders
  bill.  We'll have an analysis later... but there is a lot 
  of good stuff here.
  jamie
  
  FILE h4270.ih
            HR 4270 IH
            104th CONGRESS
            2d Session
            To require reporting on research and development expenditures for
            drugs approved for marketing, and for other purposes.
                               IN THE HOUSE OF REPRESENTATIVES
                                     September 27, 1996
            Mr. SANDERS introduced the following bill; which was referred to 
                the Committee on Commerce
                                           A BILL
            To require reporting on research and development expenditures for
            drugs approved for marketing, and for other purposes.
             [Italic->]   Be it enacted by the Senate and House of
            Representatives of the United States of America in Congress
            assembled, [<-Italic]
            SECTION 1. SHORT TITLE.
              This Act may be cited as the `Health Care Research and 
            Development and Consumer Protection Act'.
            SEC. 2. FINDINGS.
              The Congress makes the following findings:
                  (1) Public health needs are advanced by the development and
                distribution of new drug therapies
                  (2) The public interest in the development of new drug
                therapies is parallel to the public interest in controlling
                public and private health care costs.
                  (3) The Federal Government needs mechanisms to ensure that
                portions of revenues from the sale of drugs to consumers are
                reinvested in the research and development of new technologies.
                  (4) The Federal Government is the single largest supporter of
                biomedical research in the world, spending $33 billion in 1994
                alone for biomedical and related health research.
                  (5) The Federal Government provides 80 percent of the monies
                spent each year for fundamental biomedical research at
                universities, medical schools, and other non-profit institutions.
                  (6) Of all the cancer drugs developed since the founding of
                the National Cancer Institute's new drug program in 1955 and
                approved for marketing by the Food and Drug Administration
                through 1992, 34 of 37 cancer drugs, or 92 percent, were
                developed with taxpayer funds.
                  (7) The public should not have to pay twice for health care
                inventions, first as taxpayers and second as consumers.
                  (8) The Department of Health and Human Services has the
                responsibility for funding basic biomedical research, for
                funding medical treatment through the programs under titles
                XVIII and XIX of the Social Security Act, for providing direct
                medical care, and, more generally, for protecting the health 
                and safety of the public, it is incumbent upon the Secretary of
                Health and Human Services to require a reasonable relationship
                between the pricing of drugs, the public investment in those
                drugs, and the health and safety needs of the public.
                  (9) The Department of Health and Human Services, academic
                researchers, and the general public have the right to know, but
                lack the necessary information about, information about the
                actual costs for drug development, the general revenues
                generated from the sale of pharmaceutical drugs, and the
                taxpayer's investment in new drug development.
                  (10) The Department of Health and Human Services lacks the
                necessary information to make appropriate decisions about the
                reasonableness of drug
            prices or the impact of its policies on research and development of
            new medical technologies.
            SEC. 3. REPORT ON RESEARCH OF THE FEDERAL GOVERNMENT.
              (a) INVOLVEMENT OF THE FEDERAL GOVERNMENT- For each drug for 
            which an application under section 505, 507, or 512 of the Federal
            Food, Drug, and Cosmetic Act has been approved the following shall
            be reported to the Secretary of Health and Human Services:
                  (1) Each patent, cooperative research and development
                agreement under section 12 of the Stevenson-Wydler Technology
                Innovation Act of 1980, or other contractual agreement with the
                Federal Government which contributed to the development of the
                drug. The dollar amount of Federal funds expended, the agency 
                of the Federal Government which provided such funds, the dates
                of any contractual agreements, and the nature of the research
                and development activity shall be included in the report.
                  (2) Each grant, contract, or other funding mechanism of the
                Federal Government which was used to support research or
                development activities with respect to the drug, including any
                grant or contract by the Federal Government to an institution 
                of higher education or other non profit institution or other
                funds expended by the Federal Government on research and
                development which directly contributed to the development of 
                the drug. The dollar amount of Federal funds expended, the
                agency of the Federal Government which provided such funds, the
                dates of any contractual agreements, and the nature of the
                research and development activity shall be included in the
                report.
            The Secretary shall make such report available to the public.
              (b) RESEARCH AND DEVELOPMENT- 
                  (1) IN GENERAL- For each drug for which an application under
                section 505, 507, or 512 of the Federal Food, Drug, and 
                Cosmetic Act has been approved the total amount expended for
                each type of research and development of the drug in each
                calendar year, including pre-clinical research and phase I, II,
                and III clinical trials, the entity which made the 
                expenditures, and the amount provided by the Federal Government
                shall be reported to the Secretary of Health and Human Services.
                  (2) PUBLIC DISCLOSURE OF DATA- If a drug is protected under
                section 527(a) of the Federal Food, Drug, and Cosmetic Act or
                under a patent, the material reported under paragraph (1) for
                such drug shall be made available by the Secretary to the
                public. If a drug is not protected under such section or a
                patent, the Secretary shall make the report available to the
                public in a form which does not identify individual entities.
            SEC. 4. REASONABLE PRICE AGREEMENT.
              (a) IN GENERAL- If any Federal agency or any non-profit entity
            undertakes federally funded health care research and development 
            and is to convey or provide a patent or other exclusive right to 
            use such research and development for a drug or other health care
            technology, such agency or entity shall not make such conveyance or
            provide such patent or other right until the person who will 
            receive such patent or other right first agrees to a reasonable
            pricing agreement with the Secretary of Health and Human Services 
            or the Secretary makes a determination that the public interest is
            served by a waiver of the reasonable pricing agreement provided in
            accordance with subsection (b).
              (b) WAIVER- No waiver shall take effect under subsection (a)
            before the public is given notice of the proposed waiver and
            provided a reasonable opportunity to comment on the proposed 
            waiver. A decision to grant a waiver shall set out the Secretary's
            finding that such a waiver is in the public interest.
            SEC. 5. PURCHASE OF DRUGS DEVELOPED WITH TAXPAYER SUPPORT.
              For any drug approved for marketing by the Food and Drug
            Administration which was developed with significant Federal 
            support, the Secretary of Health and Human Services shall review 
            the price of the drug for purposes of determining a reasonable 
            price for Federal reimbursements under the programs under titles
            XVIII and XIX of the Social Security Act and other Federal programs
            that elect to participate in the Secretary's reasonable pricing
            program, In determining a reasonable price for a drug, the 
            Secretary shall consider--
                  (1) the public interest in continued health care research and
                development,
                  (2) the contribution of the person marketing such drug to the
                drug research and development expenses, including the amount,
                timing, and risk of investment in such research and development,
                  (3) the contribution of the Federal Government to the 
                research and development of such drug, including the amount,
                timing, and risk of investment in such research and development,
                  (4) the therapeutic value of such drug,
                  (5) the number of patients who are expected to purchase such
                drug,
                  (6) the cost of producing and marketing of such drug,
                  (7) the cost of therapies which are similar to the therapy
                using such drug, and
                  (8) other relevant factors.
            SEC. 6. MATERIAL TRANSFER AGREEMENT.
              If in connection with research and development for health care
            technologies, the Secretary of Health and Human Services determines
            that the public interest will be advanced by the ability of the
            Secretary to conduct research on biological substances or other
            materials, the Secretary shall have the authority to compel the
            owner of such substances or materials to provide the Secretary with
            such substances or materials in accordance with a materials 
            transfer agreement. The agreement shall--
                  (1) provide the owner of such substances or materials
                compensation for the costs incurred in making the transfer to
                the Secretary;
                  (2) define the terms and conditions under which the Secretary
                may use the materials;
                  (3) not grant rights in intellectual property or rights for
                commercial purposes; and
                  (4) require that the material be used for research purposes
                only.
            SEC. 7. PROMOTION OF RESEARCH AND DEVELOPMENT.
              (a) ACCOUNT- Any person engaged in the manufacture of drugs for
            introduction into interstate commerce shall, in accordance with
            subsection (b), establish for each drug an account for funds to be
            reinvested in research and development for health care technologies.
              (b) REINVESTMENT IN RESEARCH AND DEVELOPMENT- To insure that
            adequate funds are being made available for research and 
            development of new health care technologies, the Secretary of 
            Health and Human Services shall establish for persons engaged in 
            the manufacture of drugs for introduction into interstate commerce
            the minimum amount such person should make available for research
            and development of its new health care technologies based upon a
            percentage of sales revenue for that drug. The Secretary may 
            require different percentages for minimum reinvestment for 
            different classes of drugs based upon patient protection, orphan
            drug status, or magnitude of sales.
              (c) ADDITIONAL RULES- The Secretary shall adopt regulations
            concerning qualifying research and development expenditures and the
            reporting requirements for persons who are subject to subsections
            (a) and (b).
            SEC. 8. REPORTS ON SALES.
              Any person engaged in the manufacture and sale of drugs approved
            under section 505, 507, or 512 of the Federal Food, Drug, and
            Cosmetic Act shall report to the Health Care Financing
            Administration the total number of each drug it has sold and the
            total revenue it has received from such sales, including sales made
            outside the United States.
            SEC. 9. GOVERNMENT EXPENDITURE ON PRESCRIPTION DRUGS.
              The Secretary of Health and Human Services shall report to the
            Congress annually on the estimate of the amount of money the 
            Federal government expends, directly or through reimbursement, for
            the purchase of prescription drugs, including an estimate of the
            amount of money expended each year on drugs which were developed
            with significant Federal support.
  
  
  ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
  James Love / love@tap.org / P.O. Box 19367, Washington, DC 20036
  Voice: 202/387-8030; Fax 202/234-5176
  Center for Study of Responsive Law
     Consumer Project on Technology; http://www.essential.org/cpt
     Taxpayer Assets Project; http://www.tap.org
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