I 

108TH CONGRESS 

2D SESSION H. R. 4258

To promote technological advancements that will dramatically reduce the 

timeframe for the development of new medical countermeasures to treat 

or prevent disease caused by infectious disease agents or toxins that, 

through natural processes or intentional introduction, may pose a significant risk to public health now or in the future. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 4, 2004

Mr. TURNER of Texas (for himself, Mr. ANDREWS, Mrs. CHRISTENSEN, Mr. 

DICKS, Ms. HARMAN, Mr. HOYER, Ms. JACKSON-LEE of Texas, Mr. 

LANGEVIN, Ms. LOFGREN, Mr. LUCAS of Kentucky, Mr. MEEK of Florida, Ms. NORTON, Mrs. LOWEY, Ms. MILLENDER-MCDONALD, Mr. 

PALLONE, and Ms. EDDIE BERNICE JOHNSON of Texas) introduced the 

following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Armed Services and Select 

Homeland Security, for a period to be subsequently determined by the 

Speaker, in each case for consideration of such provisions as fall within 

the jurisdiction of the committee concerned 

A BILL

To promote technological advancements that will dramatically 

reduce the timeframe for the development of new medical 

countermeasures to treat or prevent disease caused by 

infectious disease agents or toxins that, through natural 

processes or intentional introduction, may pose a significant risk to public health now or in the future.

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

2 This Act may be cited as the ‘‘Rapid Pathogen Iden3 tification to Delivery of Cures Act’’. 

4 SEC. 2. FINDINGS AND POLICY. 

5 (a) FINDINGS.—The Congress finds as follows: 

6 (1) The possibility exists today that terrorists 

7 or others who intend harm to United States forces 

8 deployed abroad or to the homeland will use tech9 niques in biotechnology to enhance the trans10 missibility, stability, virulence, or host range of a bi11 ological agent, or to render existing diagnostic, 

12 therapeutic, and vaccine strategies or innate immune 

13 responses against a biological agent less effective. 

14 (2) This possibility will likely grow over time as 

15 such techniques develop, improve, and spread as an 

16 inevitable result of biotechnology innovation. 

17 (3) Natural processes can also lead to the emer18 gence of previously unknown and harmful pathogens 

19 or render known pathogens resistant to existing di20 agnostic, therapeutic, or adaptive immune ap21 proaches. 

22 (4) Long delays in developing new and effective 

23 responses to pathogens are typical. The discovery, 

24 development, and approval process for new drugs 

25 and vaccines typically requires 10 to 20 years and 

26 costs an average of $800 million. These constraints 
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1 reflect the long, costly research and development 

2 process, including the failure of most drug or vac3 cine candidates to demonstrate favorable characteris4 tics in pre-clinical testing, as well as the expensive, 

5 time-consuming clinical trials required to prove the 

6 safety and effectiveness of new treatments. 

7 (5) Congress has already authorized the 

8 abridgement of the long testing and approval process 

9 required to ensure safety and efficacy under the 

10 emergency conditions of a severe outbreak of a 

11 harmful pathogen. However, it will likely still take 

12 years for even an experimental treatment or vaccine 

13 to become available. 

14 (6) There is no coordinated, focused research 

15 and development program or overall national strat16 egy to achieve significant and dramatic reductions in 

17 the timeframe from the identification of a pathogen 

18 to the development and emergency approval for 

19 human use of reasonably safe and effective new bio20 defense medical countermeasures against a pre21 viously unknown or engineered pathogen or toxin. 

22 (7) Even utilizing existing technologies, there is 

23 no organized capability in the public or private sec24 tor to rapidly screen drug candidates for potential 

25 therapeutic activity against pathogens, develop and 
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1 manufacture drug, biological, or medical device prod2 ucts, or test already approved treatments for efficacy 

3 against a previously unknown or engineered biologi4 cal threat that puts our deployed armed forces or 

5 the homeland at risk. 

6 (8) In the area of infectious disease in par7 ticular, private sector firms are abandoning all types 

8 of innovation and research and development in favor 

9 of investments in more profitable medical markets. 

10 (9) Tremendous potential exists for benefits to 

11 health by concerted, targeted public-private invest12 ment to dramatically reduce the timeframe for the 

13 development of new countermeasures. The pharma14 ceutical and biotechnology industries are fundamen15 tally innovative and are quick to integrate new tech16 nologies. Useful and important discoveries and tech17 nological advances will be rapidly absorbed by the 

18 private sector, leading to faster delivery of new 

19 medicines and reductions in the costs of drug devel20 opment. 

21 (b) POLICY.—The Congress hereby declares it to be 

22 the national policy of the United States to promote techno23 logical advancements that will dramatically reduce the 

24 timeframe for the development of new medical counter25 measures to treat or prevent disease caused by infectious 
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1 disease agents or toxins that, through natural processes 

2 or intentional introduction, may pose a significant risk to 

3 public health now or in the future. 

4 SEC. 3. RAPID BIODEFENSE COUNTERMEASURES DEVELOP5 MENT NATIONAL STRATEGY. 

6 Title III of the Homeland Security Act of 2002 (6 

7 U.S.C. 181 et seq.) (Public Law 107–296) is amended by 

8 inserting after section 304 the following section: 

9 ‘‘SEC. 304A. RAPID BIODEFENSE COUNTERMEASURES DE10 VELOPMENT NATIONAL STRATEGY. 

11 ‘‘(a) NATIONAL STRATEGY FOR SHORTENING THE

12 MEDICAL COUNTERMEASURE DEVELOPMENT TIME13 FRAME.—Not later than 180 days after the date of the 

14 enactment of the Rapid Pathogen Identification to Deliv15 ery of Cures Act, the Secretaries of Homeland Security, 

16 Health and Human Services, and Defense shall submit to 

17 Congress a report setting forth a strategy to achieve dra18 matic reductions in the timeframe from pathogen identi19 fication to the development and emergency approval for 

20 human use of reasonably safe and effective priority coun21 termeasure against a novel or unknown pathogen or toxin. 

22 ‘‘(b) ELEMENTS.—The report under subsection (a) 

23 shall include the following: 

24 ‘‘(1) The identification of the technical impedi25 ments to reductions in the timeframe from pathogen 
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1 identification to priority countermeasure develop2 ment and approval under emergency conditions. 

3 ‘‘(2) The identification of the research, develop4 ment, and technology needs and clinical research 

5 needs to address these impediments. 

6 ‘‘(3) The identification of existing research and 

7 development efforts in Federal agencies, academia 

8 and industry that are addressing the needs identified 

9 in subsection (c)(2). 

10 ‘‘(4) The identification of facilities, programs 

11 and resources that can be utilized to address these 

12 research, development, and technology needs and 

13 clinical research needs among—

14 ‘‘(A) Federal agencies; 

15 ‘‘(B) colleges and universities; 

16 ‘‘(C) not-for-profit institutions; 

17 ‘‘(D) industry, including information tech18 nology, software, robotics, pharmaceutical and 

19 biotechnology companies and their consortia; 

20 and 

21 ‘‘(E) foreign research and technological in22 stitutions. 

23 ‘‘(5) A proposal for the establishment of a co24 ordinated and integrated federal program to address 
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1 these research, development, and technology needs, 

2 including—

3 ‘‘(A) the application of Federal Govern4 ment resources, including recommendations for 

5 the allocation and prioritization of Federal 

6 funds; 

7 ‘‘(B) interagency management and coordi8 nation mechanisms; 

9 ‘‘(C) the establishment of partnerships be10 tween private corporations and Federal agencies 

11 or Federally funded entities; 

12 ‘‘(D) information and technology sharing 

13 and coordination mechanisms among public, 

14 private, academic, not-for-profit, and inter15 national institutions; 

16 ‘‘(E) the use of incentives to promote pri17 vate sector participation; and 

18 ‘‘(F) the adjustment of Federal regulatory 

19 requirements to promote private sector innova20 tion. 

21 ‘‘(6) The identification of potential liability con22 cerns stemming from distribution of rapidly-devel23 oped priority countermeasures under emergency con24 ditions and a proposal for regulatory or legislative 

25 approaches to eliminating these concerns. 
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1 ‘‘(7) A proposal for managing the transfer of 

2 new technologies and associated intellectual property 

3 rights. 

4 ‘‘(c) CONSIDERATIONS.—In developing the national 

5 strategy under subsection (a), the Secretaries shall con6 sider—

7 ‘‘(1) the research, development, and technology 

8 needs and clinical research needs of the entire 

9 pathogen identification to priority countermeasures 

10 discovery, development, production, and approval 

11 process, including—

12 ‘‘(A) initial identification and characteriza13 tion of a pathogen or toxin, including the iden14 tification of any genetic or other manipulations; 

15 ‘‘(B) priority countermeasures discovery; 

16 ‘‘(C) pre-clinical testing and evaluation of 

17 priority countermeasures; 

18 ‘‘(D) safety and efficacy animal testing, in19 cluding the needs for approval under emergency 

20 conditions and accelerated approval of new pri21 ority countermeasure under the final rule ‘New 

22 Drug and Biological Drug Products; Evidence 

23 Needed to Demonstrate Effectiveness of New 

24 Drugs When Human Efficacy Studies Are Not 

25 Ethical or Feasible’ published in the Federal 
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1 Register on May 31, 2002 (67 Fed. Reg. 

2 37988); 

3 ‘‘(E) safety and efficacy human testing, in4 cluding mechanisms for the conduct of clinical 

5 trials under emergency conditions; 

6 ‘‘(F) research-scale and full production7 scale manufacturing, including biologics manu8 facturing sciences; and 

9 ‘‘(G) the approval of priority counter10 measure under emergency conditions; 

11 ‘‘(2) the potential importance of advanced tech12 nologies such as automation, computer modeling and 

13 simulation, bioinformatics, pharmacogenomics, and 

14 bioengineering techniques for manufacturing; 

15 ‘‘(3) the availability of sufficient manufacturing 

16 capacity for priority countermeasures production to 

17 meet potential public demand under emergency con18 ditions; and 

19 ‘‘(4) the current state of national and inter20 national collaborative research networks and applica21 tions to facilitate and encourage the rapid and co22 ordinated development and sharing of laboratory and 

23 clinical research planning and results. 

24 ‘‘(d) AUTHORITY TO CONTRACT.—The Secretary of 

25 Homeland Security, after consultation with the Secre-
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1 taries of Health and Human Services and Defense and 

2 the working group established under section 319F(a) of 

3 the Public Health Service Act, may contract with any one 

4 or more for-profit or non-profit firm or institution to con5 duct the necessary research and analysis needed to com6 plete any one or more of the elements described in sub7 section (b) of the report required in this section, provided 

8 the considerations described in subsection (c) are met. 

9 ‘‘(e) DEFINITIONS.—In this section: 

10 ‘‘(1) The term ‘emergency conditions’ refers to 

11 a declaration of emergency under section 564 of the 

12 Federal Food, Drug, and Cosmetic Act. 

13 ‘‘(2) The term ‘pathogen identification’ means 

14 the point in time in which a specific agent that can 

15 be reasonably assumed to be the cause of (or has the 

16 potential to be the cause of) an infectious disease or 

17 toxin-induced syndrome has been identified and par18 tially or wholly characterized scientifically. 

19 ‘‘(3) The term ‘priority countermeasure’ has 

20 the same meaning given such term in section 

21 319F(h) of the Public Health Service Act. 

22 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For the 

23 purpose of carrying out this section, there is authorized 

24 to be appropriated $10,000,000 for fiscal year 2005.’’. 
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1 SEC. 4. CLINICAL RESEARCH UNDER EMERGENCY CONDI2 TIONS. 

3 (a) IN GENERAL.—Not later than 180 days after the 

4 date of the enactment of this Act, the Secretary of Health 

5 and Human Services shall establish a system for the rapid 

6 establishment of clinical research programs to examine the 

7 safety and efficacy of new or existing treatments for novel, 

8 unknown, or bioengineered pathogens or toxins. The Sec9 retary shall also provide the means for rapid dissemination 

10 of results and recommendations to clinicians nationwide. 

11 (b) EMERGENCY FUND.—A fund is authorized to be 

12 established for use, at the discretion of the Secretary, sole13 ly for the support of clinical research as described in sub14 section (a). 

15 SEC. 5. INTERAGENCY WORKING GROUP. 

16 Section 319F(a) of the Public Health Service Act, as 

17 amended by Public Law 107–188, is amended—

18 (1) by inserting ‘‘the Secretary of Homeland 

19 Security,’’ after ‘‘in coordination with the’’; 

20 (2) by redesignating subparagraphs (D) 

21 through (L) as subparagraphs (E) through (M), re22 spectively; and 

23 (3) by inserting after subparagraph (C) the fol24 lowing subparagraph: 

25 ‘‘(D) development of a national strategy to 

26 achieve dramatic reductions in the timeframe 
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1 from the identification of a pathogen to the de2 velopment and approval for human use under 

3 emergency conditions of priority counter4 measures against a novel, unknown, or engi5 neered pathogen or toxin;’’. 

6 SEC. 6. DEVELOPING THE CAPABILITY FOR RAPID BIO7 DEFENSE COUNTERMEASURE DEVELOP8 MENT. 

9 (a) RESEARCH.—Section 319F(h)(1) of the Public 

10 Health Service Act, as amended by Public Law 107–188, 

11 is amended—

12 (1) in subparagraph (C), by striking ‘‘and’’ 

13 after the semicolon; 

14 (2) by redesignating subparagraph (D) as sub15 paragraph (E); and 

16 (3) by inserting after subparagraph (C) the fol17 lowing subparagraph: 

18 ‘‘(D) the development of a capability to 

19 rapidly identify, develop, produce, and approve 

20 for human use under emergency conditions pri21 ority countermeasures against a novel, un22 known, or engineered pathogen or toxin; and’’. 

23 (b) RESEARCH AND DEVELOPMENT AT THE DEPART24 MENT OF DEFENSE.—Section 1601(a) of the National 

25 Defense Authorization Act for Fiscal Year 2004 (Public 
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1 Law 108–136) is amended by adding at the end the fol2 lowing: ‘‘The program shall also include research, develop3 ment, and procurement to provide the Federal Govern4 ment with the capability to rapidly identify, develop, 

5 produce, and approve for human use under emergency 

6 conditions priority countermeasures against a novel, un7 known, or engineered pathogen or toxin, and for which no 

8 existing countermeasure has been determined to be safe 

9 or efficacious.’’. 

10 (c) RESEARCH AND DEVELOPMENT AT THE DEPART11 MENT OF HOMELAND SECURITY.—Title III of the Home12 land Security Act of 2002, as amended by section 3 of 

13 this Act, is amended by inserting after section 304A the 

14 following section: 

15 ‘‘SEC. 304B. DEVELOPING THE CAPABILITY FOR RAPID BIO16 DEFENSE COUNTERMEASURE DEVELOP17 MENT. 

18 ‘‘The Secretary, in collaboration with the Secretaries 

19 of Defense and Health and Human Services, shall carry 

20 out a program for research, development, and procure21 ment to provide the Federal Government with the capa22 bility to rapidly identify, develop, produce, and approve for 

23 human use under emergency conditions priority counter24 measures against a novel, unknown, or engineered patho-
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1 gen or toxin, and for which no existing countermeasure 

2 has been determined to be safe or efficacious.’’.

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