[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2592 Introduced in House (IH)]







110th CONGRESS
  1st Session
                                H. R. 2592

To amend the Federal Food, Drug, and Cosmetic Act to provide for one or 
    more Critical Path Public-Private Partnerships to implement the 
 Critical Path Initiative of the Food and Drug Administration, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              June 6, 2007

   Ms. Giffords (for herself, Mrs. Blackburn, and Mr. Hall of Texas) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to provide for one or 
    more Critical Path Public-Private Partnerships to implement the 
 Critical Path Initiative of the Food and Drug Administration, 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 ``Safe and Effective Drug Development 
Act of 2007''.

SEC. 2. PURPOSE.

    The purpose of this Act is to provide for one or more Critical Path 
Public-Private Partnerships to accelerate the translation of new 
scientific discoveries into new medical products that will cure and 
better treat disease, improve health care, prolong longevity and 
wellness, reduce health care costs, and enhance American 
competitiveness in the 21st century.

SEC. 3. FINDINGS.

    The Congress finds as follows:
            (1) The Critical Path Initiative is the Food and Drug 
        Administration's effort to stimulate and facilitate a national 
        effort to modernize the process of innovation and 
        commercialization through which fundamental scientific 
        discoveries are transformed from ``proof of concept'' and 
        development into breakthrough medical products, therapies, and 
        cures.
            (2) On March 16, 2004, the Food and Drug Administration 
        released a report entitled ``Innovation/Stagnation: Challenge 
        and Opportunity on the Critical Path to New Medical Products'', 
        addressing the recent slowdown in innovative medical therapies 
        submitted to the Food and Drug Administration for approval. The 
        report describes the urgent need to modernize the medical 
        product development process--the Critical Path--to make product 
        development more predictable and efficient.
            (3) The Food and Drug Administration has committed to 
        working with companies, patient groups, academic researchers, 
        and other stakeholders to coordinate, develop, and disseminate 
        solutions to scientific hurdles that are impairing the 
        efficiency of product development across the life science 
        industries. For example, the Food and Drug Administration has 
        released a Critical Path Opportunities List of over 75 research 
        priorities that, if accomplished, would modernize the drug 
        development process by 2010 and would help to make new medical 
        discoveries available to Americans faster and at a lower cost.
            (4) The Food and Drug Administration has already initiated 
        partnerships to share knowledge, streamline the cost and time 
        of preclinical drug safety evaluation, and better inform the 
        use of ``personalized medicine''.
            (5) However, much more must be done to foster the 
        collaborative culture that must exist to modernize the medical 
        product development process. Collective sharing of scientific 
        information and research methodology across the entire health 
        care community is crucial to igniting the medical innovation 
        required to keep pace with biomedical research.
            (6) The power of public-private partnerships is vital to 
        accomplish these tasks and to ensure that new scientific 
        discoveries--in fields such as genomics and proteomics, 
        imaging, and bioinformatics--can be more rapidly and 
        effectively applied to cure diseases, enhance treatments, 
        improve health care, prolong longevity and wellness, reduce 
        health care costs, and enhance American competitiveness in the 
        21st century.

SEC. 4. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.

    Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the 
following:

``SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.

    ``(a) Establishment.--The Secretary, acting through the 
Commissioner of Food and Drugs, shall enter into one or more 
collaborative agreements, to be known as Critical Path Public-Private 
Partnerships, with one or more eligible entities to implement the 
Critical Path Initiative of the Food and Drug Administration by 
developing innovative, collaborative projects in research, education, 
and outreach for the purpose of fostering medical product innovation, 
enabling the acceleration of medical product development, and enhancing 
medical product safety.
    ``(b) Eligible Entity.--In this section, the term `eligible entity' 
means an entity that meets each of the following:
            ``(1) The entity is--
                    ``(A) an institution of higher education (as such 
                term is defined in section 101 of the Higher Education 
                Act of 1965); or
                    ``(B) an organization described in section 
                501(c)(3) of the Internal Revenue Code of 1986 and 
                exempt from tax under section 501(a) of such Code.
            ``(2) The entity has experienced personnel and clinical and 
        other technical expertise in the biomedical sciences.
            ``(3) The entity demonstrates to the Secretary's 
        satisfaction that the entity is capable of--
                    ``(A) developing and critically evaluating tools, 
                methods, and processes--
                            ``(i) to increase efficiency, 
                        predictability, and productivity of medical 
                        product development; and
                            ``(ii) to more accurately identify the 
                        benefits and risks of new and existing medical 
                        products;
                    ``(B) establishing partnerships, consortia, and 
                collaborations with health care practitioners and other 
                providers of health care goods or services; 
                pharmacists; pharmacy benefit managers and purchasers; 
                health maintenance organizations and other managed 
                health care organizations; health care insurers; 
                government agencies; patients and consumers; 
                manufacturers of prescription drugs, biological 
                products, diagnostic technologies, and devices; and 
                academic scientists; and
                    ``(C) securing funding for the technical programs 
                of a Critical Path Public-Private Partnership from 
                Federal and nonfederal governmental sources, 
                foundations, and private individuals.
    ``(c) Funding From Certain Individuals and Organizations.--
            ``(1) Prohibition.--The Secretary may not enter into a 
        collaborative agreement under subsection (a) unless the 
        eligible entity involved provides an assurance that the entity 
        will not accept any funding for the technical programs of a 
        Critical Path Public-Private Partnership from any individual or 
        organization that manufactures, distributes, or sells any 
        product that is regulated by the Food and Drug Administration.
            ``(2) Waiver.--Paragraph (1) (and any assurance provided 
        thereunder) does not prohibit an eligible entity from accepting 
        funding from a consortium of companies whose products are 
        regulated by the Food and Drug Administration if the 
        Secretary--
                    ``(A) determines that such acceptance would not 
                result in any conflict of interest for the eligible 
                entity, the Partnership, or the Government; and
                    ``(B) issues a waiver allowing such acceptance.
    ``(d) Annual Report.--Not later than 18 months after the date of 
the enactment of this section, and annually thereafter, the Secretary, 
in collaboration with the parties to each Critical Path Public-Private 
Partnership, shall submit a 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--
            ``(1) reviewing the operations and activities of the 
        Partnerships in the previous year; and
            ``(2) addressing such other issues relating to this section 
        as the Secretary determines to be appropriate.
    ``(e) Definition.--In this section, the term `medical product' 
includes a drug, a diagnostic test, a biological product, a device, and 
any innovative combination of such products.
    ``(f) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $5,000,000 for fiscal year 2008 
and such sums as may be necessary for each of fiscal years 2009 through 
2012.''.
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