[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 2793 Introduced in Senate (IS)]








109th CONGRESS
  2d Session
                                S. 2793

 To enhance research and education in the areas of pharmaceutical and 
 biotechnology science and engineering, including therapy development 
 and manufacturing, analytical technologies, modeling, and informatics.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 11, 2006

   Mr. Lugar introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To enhance research and education in the areas of pharmaceutical and 
 biotechnology science and engineering, including therapy development 
 and manufacturing, analytical technologies, modeling, and informatics.

    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 ``Pharmaceutical Technology and 
Education Enhancement Act''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Developing medical products targeted for important 
        public health needs, less common diseases, prevalent third 
        world diseases, prevention indications, or individualized 
        therapy is increasingly challenging.
            (2) A typical compound that is discovered today may not be 
        approved by the Food and Drug Administration for 12 to 15 
        years.
            (3) Current costs of bringing new medicines to market are 
        estimated to be as high as $800,000,000 to $1,700,000,000 and 
        are a major barrier to innovation and investment in higher-risk 
        areas such as rare diseases and genetic conditions.
            (4) Product development in areas crucial to public health, 
        such as antibiotics, has slowed significantly in the past 
        decade.
            (5) Approximately 50 percent of new drug candidates fail to 
        produce adequate evidence of safety or effectiveness in the 
        late stages of clinical studies and cannot be approved. The 
        resulting overall investments are raising the cost of 
        developing an approved therapy to approximately $1,700,000,000.
            (6) Problems in physical design, characterization, 
        manufacturing scale-up, and quality control routinely derail or 
        delay development programs and delay patient access to new 
        treatments.
            (7) Many product failures during development are ultimately 
        attributable to problems relating to the transition from 
        laboratory prototype to industrial product.
            (8) Recent data suggests that the investment required to 
        launch a new therapy has risen 55 percent during the last 5 
        years. Pharmaceutical, biotechnology, and medical device 
        productivity appears to be declining at the same time that the 
        costs to develop treatments are rising.
            (9) During the last several years, the number of new drug 
        and biologic applications submitted to the Food and Drug 
        Administration has declined significantly. The number of 
        innovative medical device applications to the Food and Drug 
        Administration also has decreased.
            (10) Industry has been hesitant to introduce state-of-the-
        art science and technology into its manufacturing processes due 
        to concern about potential regulatory impact. This led to high 
        in-process inventories, low factory utilization rates, 
        significant product waste, and compliance problems, driving up 
        the costs and decreasing productivity.
            (11) It is crucial that improved methods for design, 
        characterization, and production manufacture are available to 
        improve predictability.
            (12) United States academic institutions have the capacity 
        to assist in discovering and introducing science-based 
        standards for product characterization and manufacturing to 
        help reduce the cost of new therapies.
            (13) Federal investments in a major pharmaceutical 
        technology and education initiative led by the Food and Drug 
        Administration in collaboration with university research 
        partners will produce multiple benefits in health care quality 
        and access.

SEC. 3. PHARMACEUTICAL TECHNOLOGY RESEARCH AND EDUCATION.

    (a) Expansion, Intensification, and Coordination of Activities.--
            (1) In general.--
                    (A) Expand and intensify certain programs.--The 
                Commissioner of Food and Drugs (referred to in this Act 
                as the ``Commissioner'') shall expand and intensify 
                certain research and education programs regarding 
                pharmaceutical science and engineering through the 
                National Institute for Pharmaceutical Technology and 
                Education (referred to in this Act as the ``NIPTE'') 
                and the member institutions of the NIPTE, including 
                Purdue University, Duquesne University, Illinois 
                Institute of Technology, University of Puerto Rico 
                (Mayaguez and San Juan), University of Connecticut, 
                University of Iowa, University of Kentucky, University 
                of Kansas, University of Maryland, University of 
                Minnesota, and Rutgers University.
                    (B) Focus.--The research and education programs 
                described in subparagraph (A) shall focus on medical 
                therapy development and manufacturing, analytical 
                technologies, modeling, and informatics.
            (2) Coordination.--The Commissioner shall coordinate 
        activities carried out pursuant to this Act with the member 
        institutions of the NIPTE identified in paragraph (1), and 
        other Federal agencies with an interest in such activities, 
        including the National Institutes of Health, the Centers for 
        Disease Control and Prevention, the Centers for Medicare & 
        Medicaid Services, the National Science Foundation, the 
        Department of Veterans Affairs, and the Department of Defense.
            (3) Allocations.--The Commissioner shall allocate amounts 
        appropriated to carry out this subsection for each fiscal year 
        to the NIPTE.
    (b) Coordinating Committee.--
            (1) In general.--The Commissioner shall assist with and 
        coordinate research and develop strategies to allow for the 
        rapid design, enhanced manufacturing processes, and improved 
        quality related to new medical technology development by 
        establishing a Coordinating Committee pursuant to this 
        subsection.
            (2) Composition.--The Coordinating Committee shall consist 
        of 15 members to be appointed by the Commissioner for 2-year 
        terms, of which--
                    (A) 8 members shall represent the Federal agencies 
                described in subsection (a)(2) and the Food and Drug 
                Administration; and
                    (B) 7 members shall be representatives from the 
                public, including a broad cross section of academic, 
                industry, consumer advocacy, and other interested 
                persons affected by the costs of prescription drugs.
            (3) Chair.--
                    (A) In general.--The Coordinating Committee shall 
                be headed by a Chair who shall serve as the principal 
                advisor to the Commissioner and to the heads of the 
                Federal agencies represented on the Coordinating 
                Committee.
                    (B) Appointment.--The Commissioner shall appoint 
                the Chair of the Coordinating Committee for a 2-year 
                term. The Commissioner may reappoint the Chair for not 
                more than 1 additional 2-year term.
            (4) Administrative support.--The Coordinating Committee 
        shall receive necessary and appropriate administrative support 
        from the Food and Drug Administration.
            (5) Meetings of the coordinating committee.--The 
        Coordinating Committee shall meet as appropriate, as determined 
        by the Commissioner in consultation with the Chair.
    (c) Plan for Food and Drug Administration Activities.--
            (1) In general.--Not later than 1 year after the date of 
        enactment of this Act, the Coordinating Committee shall develop 
        a plan for supporting research and education efforts through 
        the NIPTE and the relevant Federal agency participants that--
                    (A) provides for a broad range of research and 
                education activities to enhance medical technology 
                manufacturing and development;
                    (B) identifies areas of involvement for the 
                participating Federal agencies; and
                    (C) reflects input from a broad range of academic, 
                industry, and patient advocacy interests.
            (2) Certain elements of the plan.--The plan under paragraph 
        (1) shall provide, with respect to medical technology 
        development and manufacturing, for the following elements, as 
        appropriate:
                    (A) Basic and applied research.
                    (B) Information and education programs.
    (d) Reports to Congress.--The Coordinating Committee shall submit a 
biennial report to the Committee on Health, Education, Labor, and 
Pensions of the Senate, and the Committee on Energy and Commerce of the 
House of Representatives that describes the research, education, and 
other activities conducted or supported pursuant to this Act.
    (e) Public Input.--The Commissioner shall provide for a means 
through which--
            (1) the public can obtain information on the existing and 
        planned programs and activities carried out pursuant to this 
        Act; and
            (2) the Commissioner can receive comments from the public 
        regarding such programs and activities.
    (f) Authorization of Appropriations.--
            (1) In general.--For the purpose of carrying out this Act, 
        there are authorized to be appropriated $25,000,000 for each of 
        fiscal years 2007 through 2012.
            (2) Additional available appropriations.--The authorization 
        of appropriations under paragraph (1) is in addition to any 
        other appropriations available for conducting or supporting 
        medical technology development and research activities through 
        the Food and Drug Administration.
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