I 
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 Crit-
ical 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) intro-
duced 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 Representa-
tives 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’’. 
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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 facili-
tate a national effort to modernize the process of in-
novation and commercialization through which fun-
damental scientific discoveries are transformed from 
‘‘proof of concept’’ and development into break-
through medical products, therapies, and cures. 
(2) On March 16, 2004, the Food and Drug 
Administration released a report entitled ‘‘Innova-
tion/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 proc-
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ess—the Critical Path—to make product develop-
ment more predictable and efficient. 
(3) The Food and Drug Administration has 
committed to working with companies, patient 
groups, academic researchers, and other stake-
holders to coordinate, develop, and disseminate solu-
tions to scientific hurdles that are impairing the effi-
ciency of product development across the life science 
industries. For example, the Food and Drug Admin-
istration has released a Critical Path Opportunities 
List of over 75 research priorities that, if accom-
plished, would modernize the drug development proc-
ess 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 al-
ready initiated partnerships to share knowledge, 
streamline the cost and time of preclinical drug safe-
ty evaluation, and better inform the use of ‘‘person-
alized medicine’’. 
(5) However, much more must be done to foster 
the collaborative culture that must exist to mod-
ernize the medical product development process. Col-
lective sharing of scientific information and research 
methodology across the entire health care commu-
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nity is crucial to igniting the medical innovation re-
quired 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 dis-
eases, enhance treatments, improve health care, pro-
long 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 PARTNER-
SHIPS. 
‘‘(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 Ini-
tiative of the Food and Drug Administration by developing 
innovative, collaborative projects in research, education, 
and outreach for the purpose of fostering medical product 
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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 High-
er 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 bio-
medical 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, predict-
ability, and productivity of medical product 
development; and 
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