Safe and Effective Drug Development Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to enter into Critical Path Public-Private Partnerships with eligible entities to implement the Critical Path Initiative of the Food and Drug Administration (FDA) by developing research, education, and outreach projects to foster medical product innovation, accelerate medical product development, and enhance medical product safety. Prohibits such an entity from accepting any funding for the technical programs of a Critical Path Public-Private Partnership from any individual or organization that manufactures, distributes, or sells any FDA-regulated product. Establishes an exception for accepting funds from a consortium of companies whose products are FDA-regulated if the Secretary determines that such acceptance would not result in any conflict of interest and issues a waiver.
[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.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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