II 

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. 

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 ‘‘Pharmaceutical Tech5 nology and Education Enhancement Act’’. 

6 SEC. 2. FINDINGS. 

7 Congress makes the following findings: 


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1 (1) Developing medical products targeted for 

2 important public health needs, less common diseases, 

3 prevalent third world diseases, prevention indica4 tions, or individualized therapy is increasingly chal5 lenging. 

6 (2) A typical compound that is discovered today 

7 may not be approved by the Food and Drug Admin8 istration for 12 to 15 years. 

9 (3) Current costs of bringing new medicines to 

10 market are estimated to be as high as $800,000,000 

11 to $1,700,000,000 and are a major barrier to inno12 vation and investment in higher-risk areas such as 

13 rare diseases and genetic conditions. 

14 (4) Product development in areas crucial to 

15 public health, such as antibiotics, has slowed signifi16 cantly in the past decade. 

17 (5) Approximately 50 percent of new drug can18 didates fail to produce adequate evidence of safety 

19 or effectiveness in the late stages of clinical studies 

20 and cannot be approved. The resulting overall in21 vestments are raising the cost of developing an ap22 proved therapy to approximately $1,700,000,000. 

23 (6) Problems in physical design, characteriza24 tion, manufacturing scale-up, and quality control 


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1 routinely derail or delay development programs and 

2 delay patient access to new treatments. 

3 (7) Many product failures during development 

4 are ultimately attributable to problems relating to 

5 the transition from laboratory prototype to indus6 trial product. 

7 (8) Recent data suggests that the investment 

8 required to launch a new therapy has risen 55 per9 cent during the last 5 years. Pharmaceutical, bio10 technology, and medical device productivity appears 

11 to be declining at the same time that the costs to 

12 develop treatments are rising. 

13 (9) During the last several years, the number of 

14 new drug and biologic applications submitted to the 

15 Food and Drug Administration has declined signifi16 cantly. The number of innovative medical device ap17 plications to the Food and Drug Administration also 

18 has decreased. 

19 (10) Industry has been hesitant to introduce 

20 state-of-the-art science and technology into its man21 ufacturing processes due to concern about potential 

22 regulatory impact. This led to high in-process inven23 tories, low factory utilization rates, significant prod24 uct waste, and compliance problems, driving up the 

25 costs and decreasing productivity. 


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1 (11) It is crucial that improved methods for de2 sign, characterization, and production manufacture 

3 are available to improve predictability. 

4 (12) United States academic institutions have 

5 the capacity to assist in discovering and introducing 

6 science-based standards for product characterization 

7 and manufacturing to help reduce the cost of new 

8 therapies. 

9 (13) Federal investments in a major pharma10 ceutical technology and education initiative led by 

11 the Food and Drug Administration in collaboration 

12 with university research partners will produce mul13 tiple benefits in health care quality and access. 

14 SEC. 3. PHARMACEUTICAL TECHNOLOGY RESEARCH AND 

15 EDUCATION. 

16 (a) EXPANSION, INTENSIFICATION, AND COORDINA17 TION OF ACTIVITIES.— 

18 (1) IN GENERAL.— 

19 (A) EXPAND AND INTENSIFY CERTAIN

20 PROGRAMS.—The Commissioner of Food and 

21 Drugs (referred to in this Act as the ‘‘Commis22 sioner’’) shall expand and intensify certain re23 search and education programs regarding phar24 maceutical science and engineering through the 

25 National Institute for Pharmaceutical TechVerDate Aug 31 2005 04:26 May 13, 2006 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2793.IS S2793

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1 nology and Education (referred to in this Act 

2 as the ‘‘NIPTE’’) and the member institutions 

3 of the NIPTE, including Purdue University, 

4 Duquesne University, Illinois Institute of Tech5 nology, University of Puerto Rico (Mayaguez 

6 and San Juan), University of Connecticut, Uni7 versity of Iowa, University of Kentucky, Univer8 sity of Kansas, University of Maryland, Univer9 sity of Minnesota, and Rutgers University. 

10 (B) FOCUS.—The research and education 

11 programs described in subparagraph (A) shall 

12 focus on medical therapy development and man13 ufacturing, analytical technologies, modeling, 

14 and informatics. 

15 (2) COORDINATION.—The Commissioner shall 

16 coordinate activities carried out pursuant to this Act 

17 with the member institutions of the NIPTE identi18 fied in paragraph (1), and other Federal agencies 

19 with an interest in such activities, including the Na20 tional Institutes of Health, the Centers for Disease 

21 Control and Prevention, the Centers for Medicare & 

22 Medicaid Services, the National Science Foundation, 

23 the Department of Veterans Affairs, and the De24 partment of Defense. 


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1 (3) ALLOCATIONS.—The Commissioner shall al2 locate amounts appropriated to carry out this sub3 section for each fiscal year to the NIPTE. 

4 (b) COORDINATING COMMITTEE.— 

5 (1) IN GENERAL.—The Commissioner shall as6 sist with and coordinate research and develop strate7 gies to allow for the rapid design, enhanced manu8 facturing processes, and improved quality related to 

9 new medical technology development by establishing 

10 a Coordinating Committee pursuant to this sub11 section. 

12 (2) COMPOSITION.—The Coordinating Com13 mittee shall consist of 15 members to be appointed 

14 by the Commissioner for 2-year terms, of which— 

15 (A) 8 members shall represent the Federal 

16 agencies described in subsection (a)(2) and the 

17 Food and Drug Administration; and 

18 (B) 7 members shall be representatives 

19 from the public, including a broad cross section 

20 of academic, industry, consumer advocacy, and 

21 other interested persons affected by the costs of 

22 prescription drugs. 

23 (3) CHAIR.— 

24 (A) IN GENERAL.—The Coordinating Com25 mittee shall be headed by a Chair who shall 


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1 serve as the principal advisor to the Commis2 sioner and to the heads of the Federal agencies 

3 represented on the Coordinating Committee. 

4 (B) APPOINTMENT.—The Commissioner 

5 shall appoint the Chair of the Coordinating 

6 Committee for a 2-year term. The Commis7 sioner may reappoint the Chair for not more 

8 than 1 additional 2-year term. 

9 (4) ADMINISTRATIVE SUPPORT.—The Coordi10 nating Committee shall receive necessary and appro11 priate administrative support from the Food and 

12 Drug Administration. 

13 (5) MEETINGS OF THE COORDINATING COM14 MITTEE.—The Coordinating Committee shall meet 

15 as appropriate, as determined by the Commissioner 

16 in consultation with the Chair. 

17 (c) PLAN FOR FOOD AND DRUG ADMINISTRATION

18 ACTIVITIES.— 

19 (1) IN GENERAL.—Not later than 1 year after 

20 the date of enactment of this Act, the Coordinating 

21 Committee shall develop a plan for supporting re22 search and education efforts through the NIPTE 

23 and the relevant Federal agency participants that— 


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1 (A) provides for a broad range of research 

2 and education activities to enhance medical 

3 technology manufacturing and development; 

4 (B) identifies areas of involvement for the 

5 participating Federal agencies; and 

6 (C) reflects input from a broad range of 

7 academic, industry, and patient advocacy inter8 ests. 

9 (2) CERTAIN ELEMENTS OF THE PLAN.—The 

10 plan under paragraph (1) shall provide, with respect 

11 to medical technology development and manufac12 turing, for the following elements, as appropriate: 

13 (A) Basic and applied research. 

14 (B) Information and education programs. 

15 (d) REPORTS TO CONGRESS.—The Coordinating 

16 Committee shall submit a biennial report to the Com17 mittee on Health, Education, Labor, and Pensions of the 

18 Senate, and the Committee on Energy and Commerce of 

19 the House of Representatives that describes the research, 

20 education, and other activities conducted or supported 

21 pursuant to this Act. 

22 (e) PUBLIC INPUT.—The Commissioner shall provide 

23 for a means through which— 


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1 (1) the public can obtain information on the ex2 isting and planned programs and activities carried 

3 out pursuant to this Act; and 

4 (2) the Commissioner can receive comments 

5 from the public regarding such programs and activi6 ties. 

7 (f) AUTHORIZATION OF APPROPRIATIONS.— 

8 (1) IN GENERAL.—For the purpose of carrying 

9 out this Act, there are authorized to be appropriated 

10 $25,000,000 for each of fiscal years 2007 through 

11 2012. 

12 (2) ADDITIONAL AVAILABLE APPROPRIA13 TIONS.—The authorization of appropriations under 

14 paragraph (1) is in addition to any other appropria15 tions available for conducting or supporting medical 

16 technology development and research activities 

17 through the Food and Drug Administration. 

Æ 


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