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 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Safe and Effective 

5 Drug Development Act of 2007’’. 


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1 SEC. 2. PURPOSE. 

2 The purpose of this Act is to provide for one or more 

3 Critical Path Public-Private Partnerships to accelerate the 

4 translation of new scientific discoveries into new medical 

5 products that will cure and better treat disease, improve 

6 health care, prolong longevity and wellness, reduce health 

7 care costs, and enhance American competitiveness in the 

8 21st century. 

9 SEC. 3. FINDINGS. 

10 The Congress finds as follows: 

11 (1) The Critical Path Initiative is the Food and 

12 Drug Administration’s effort to stimulate and facili13 tate a national effort to modernize the process of in14 novation and commercialization through which fun15 damental scientific discoveries are transformed from 

16 ‘‘proof of concept’’ and development into break17 through medical products, therapies, and cures. 

18 (2) On March 16, 2004, the Food and Drug 

19 Administration released a report entitled ‘‘Innova20 tion/Stagnation: Challenge and Opportunity on the 

21 Critical Path to New Medical Products’’, addressing 

22 the recent slowdown in innovative medical therapies 

23 submitted to the Food and Drug Administration for 

24 approval. The report describes the urgent need to 

25 modernize the medical product development procVerDate Aug 31 2005 21:36 Jun 08, 2007 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2592.IH H2592

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1 ess—the Critical Path—to make product develop2 ment more predictable and efficient. 

3 (3) The Food and Drug Administration has 

4 committed to working with companies, patient 

5 groups, academic researchers, and other stake6 holders to coordinate, develop, and disseminate solu7 tions to scientific hurdles that are impairing the effi8 ciency of product development across the life science 

9 industries. For example, the Food and Drug Admin10 istration has released a Critical Path Opportunities 

11 List of over 75 research priorities that, if accom12 plished, would modernize the drug development proc13 ess by 2010 and would help to make new medical 

14 discoveries available to Americans faster and at a 

15 lower cost. 

16 (4) The Food and Drug Administration has al17 ready initiated partnerships to share knowledge, 

18 streamline the cost and time of preclinical drug safe19 ty evaluation, and better inform the use of ‘‘person20 alized medicine’’. 

21 (5) However, much more must be done to foster 

22 the collaborative culture that must exist to mod23 ernize the medical product development process. Col24 lective sharing of scientific information and research 

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1 nity is crucial to igniting the medical innovation re2 quired to keep pace with biomedical research. 

3 (6) The power of public-private partnerships is 

4 vital to accomplish these tasks and to ensure that 

5 new scientific discoveries—in fields such as genomics 

6 and proteomics, imaging, and bioinformatics—can 

7 be more rapidly and effectively applied to cure dis8 eases, enhance treatments, improve health care, pro9 long longevity and wellness, reduce health care costs, 

10 and enhance American competitiveness in the 21st 

11 century. 

12 SEC. 4. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS. 

13 Subchapter E of chapter V of the Federal Food, 

14 Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is 

15 amended by adding at the end the following: 

16 ‘‘SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNER17 SHIPS. 

18 ‘‘(a) ESTABLISHMENT.—The Secretary, acting 

19 through the Commissioner of Food and Drugs, shall enter 

20 into one or more collaborative agreements, to be known 

21 as Critical Path Public-Private Partnerships, with one or 

22 more eligible entities to implement the Critical Path Ini23 tiative of the Food and Drug Administration by developing 

24 innovative, collaborative projects in research, education, 

25 and outreach for the purpose of fostering medical product 


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1 innovation, enabling the acceleration of medical product 

2 development, and enhancing medical product safety. 

3 ‘‘(b) ELIGIBLE ENTITY.—In this section, the term 

4 ‘eligible entity’ means an entity that meets each of the 

5 following: 

6 ‘‘(1) The entity is— 

7 ‘‘(A) an institution of higher education (as 

8 such term is defined in section 101 of the High9 er Education Act of 1965); or 

10 ‘‘(B) an organization described in section 

11 501(c)(3) of the Internal Revenue Code of 1986 

12 and exempt from tax under section 501(a) of 

13 such Code. 

14 ‘‘(2) The entity has experienced personnel and 

15 clinical and other technical expertise in the bio16 medical sciences. 

17 ‘‘(3) The entity demonstrates to the Secretary’s 

18 satisfaction that the entity is capable of— 

19 ‘‘(A) developing and critically evaluating 

20 tools, methods, and processes— 

21 ‘‘(i) to increase efficiency, predict22 ability, and productivity of medical product 

23 development; and 


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1 ‘‘(ii) to more accurately identify the 

2 benefits and risks of new and existing med3 ical products; 

4 ‘‘(B) establishing partnerships, consortia, 

5 and collaborations with health care practitioners 

6 and other providers of health care goods or 

7 services; pharmacists; pharmacy benefit man8 agers and purchasers; health maintenance orga9 nizations and other managed health care orga10 nizations; health care insurers; government 

11 agencies; patients and consumers; manufactur12 ers of prescription drugs, biological products, 

13 diagnostic technologies, and devices; and aca14 demic scientists; and 

15 ‘‘(C) securing funding for the technical 

16 programs of a Critical Path Public-Private 

17 Partnership from Federal and nonfederal gov18 ernmental sources, foundations, and private in19 dividuals. 

20 ‘‘(c) FUNDING FROM CERTAIN INDIVIDUALS AND

21 ORGANIZATIONS.— 

22 ‘‘(1) PROHIBITION.—The Secretary may not 

23 enter into a collaborative agreement under sub24 section (a) unless the eligible entity involved provides 

25 an assurance that the entity will not accept any 


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1 funding for the technical programs of a Critical 

2 Path Public-Private Partnership from any individual 

3 or organization that manufactures, distributes, or 

4 sells any product that is regulated by the Food and 

5 Drug Administration. 

6 ‘‘(2) WAIVER.—Paragraph (1) (and any assur7 ance provided thereunder) does not prohibit an eligi8 ble entity from accepting funding from a consortium 

9 of companies whose products are regulated by the 

10 Food and Drug Administration if the Secretary— 

11 ‘‘(A) determines that such acceptance 

12 would not result in any conflict of interest for 

13 the eligible entity, the Partnership, or the Gov14 ernment; and 

15 ‘‘(B) issues a waiver allowing such accept16 ance. 

17 ‘‘(d) ANNUAL REPORT.—Not later than 18 months 

18 after the date of the enactment of this section, and annu19 ally thereafter, the Secretary, in collaboration with the 

20 parties to each Critical Path Public-Private Partnership, 

21 shall submit a report to the Committee on Health, Edu22 cation, Labor, and Pensions of the Senate and the Com23 mittee on Energy and Commerce of the House of Rep24 resentatives— 


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1 ‘‘(1) reviewing the operations and activities of 

2 the Partnerships in the previous year; and 

3 ‘‘(2) addressing such other issues relating to 

4 this section as the Secretary determines to be appro5 priate. 

6 ‘‘(e) DEFINITION.—In this section, the term ‘medical 

7 product’ includes a drug, a diagnostic test, a biological 

8 product, a device, and any innovative combination of such 

9 products. 

10 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—To 

11 carry out this section, there are authorized to be appro12 priated $5,000,000 for fiscal year 2008 and such sums 

13 as may be necessary for each of fiscal years 2009 through 

14 2012.’’. 

Æ 


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