[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4258 Introduced in House (IH)]






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.

    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 ``Rapid Pathogen Identification to 
Delivery of Cures Act''.

SEC. 2. FINDINGS AND POLICY.

    (a) Findings.--The Congress finds as follows:
            (1) The possibility exists today that terrorists or others 
        who intend harm to United States forces deployed abroad or to 
        the homeland will use techniques in biotechnology to enhance 
        the transmissibility, stability, virulence, or host range of a 
        biological agent, or to render existing diagnostic, 
        therapeutic, and vaccine strategies or innate immune responses 
        against a biological agent less effective.
            (2) This possibility will likely grow over time as such 
        techniques develop, improve, and spread as an inevitable result 
        of biotechnology innovation.
            (3) Natural processes can also lead to the emergence of 
        previously unknown and harmful pathogens or render known 
        pathogens resistant to existing diagnostic, therapeutic, or 
        adaptive immune approaches.
            (4) Long delays in developing new and effective responses 
        to pathogens are typical. The discovery, development, and 
        approval process for new drugs and vaccines typically requires 
        10 to 20 years and costs an average of $800 million. These 
        constraints reflect the long, costly research and development 
        process, including the failure of most drug or vaccine 
        candidates to demonstrate favorable characteristics in pre-
        clinical testing, as well as the expensive, time-consuming 
        clinical trials required to prove the safety and effectiveness 
        of new treatments.
            (5) Congress has already authorized the abridgement of the 
        long testing and approval process required to ensure safety and 
        efficacy under the emergency conditions of a severe outbreak of 
        a harmful pathogen. However, it will likely still take years 
        for even an experimental treatment or vaccine to become 
        available.
            (6) There is no coordinated, focused research and 
        development program or overall national strategy to achieve 
        significant and dramatic reductions in the timeframe from the 
        identification of a pathogen to the development and emergency 
        approval for human use of reasonably safe and effective new 
        biodefense medical countermeasures against a previously unknown 
        or engineered pathogen or toxin.
            (7) Even utilizing existing technologies, there is no 
        organized capability in the public or private sector to rapidly 
        screen drug candidates for potential therapeutic activity 
        against pathogens, develop and manufacture drug, biological, or 
        medical device products, or test already approved treatments 
        for efficacy against a previously unknown or engineered 
        biological threat that puts our deployed armed forces or the 
        homeland at risk.
            (8) In the area of infectious disease in particular, 
        private sector firms are abandoning all types of innovation and 
        research and development in favor of investments in more 
        profitable medical markets.
            (9) Tremendous potential exists for benefits to health by 
        concerted, targeted public-private investment to dramatically 
        reduce the timeframe for the development of new 
        countermeasures. The pharmaceutical and biotechnology 
        industries are fundamentally innovative and are quick to 
        integrate new technologies. Useful and important discoveries 
        and technological advances will be rapidly absorbed by the 
        private sector, leading to faster delivery of new medicines and 
        reductions in the costs of drug development.
    (b) Policy.--The Congress hereby declares it to be the national 
policy of the United States 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.

SEC. 3. RAPID BIODEFENSE COUNTERMEASURES DEVELOPMENT NATIONAL STRATEGY.

    Title III of the Homeland Security Act of 2002 (6 U.S.C. 181 et 
seq.) (Public Law 107-296) is amended by inserting after section 304 
the following section:

``SEC. 304A. RAPID BIODEFENSE COUNTERMEASURES DEVELOPMENT NATIONAL 
              STRATEGY.

    ``(a) National Strategy for Shortening the Medical Countermeasure 
Development Timeframe.--Not later than 180 days after the date of the 
enactment of the Rapid Pathogen Identification to Delivery of Cures 
Act, the Secretaries of Homeland Security, Health and Human Services, 
and Defense shall submit to Congress a report setting forth a strategy 
to achieve dramatic reductions in the timeframe from pathogen 
identification to the development and emergency approval for human use 
of reasonably safe and effective priority countermeasure against a 
novel or unknown pathogen or toxin.
    ``(b) Elements.--The report under subsection (a) shall include the 
following:
            ``(1) The identification of the technical impediments to 
        reductions in the timeframe from pathogen identification to 
        priority countermeasure development and approval under 
        emergency conditions.
            ``(2) The identification of the research, development, and 
        technology needs and clinical research needs to address these 
        impediments.
            ``(3) The identification of existing research and 
        development efforts in Federal agencies, academia and industry 
        that are addressing the needs identified in subsection (c)(2).
            ``(4) The identification of facilities, programs and 
        resources that can be utilized to address these research, 
        development, and technology needs and clinical research needs 
        among--
                    ``(A) Federal agencies;
                    ``(B) colleges and universities;
                    ``(C) not-for-profit institutions;
                    ``(D) industry, including information technology, 
                software, robotics, pharmaceutical and biotechnology 
                companies and their consortia; and
                    ``(E) foreign research and technological 
                institutions.
            ``(5) A proposal for the establishment of a coordinated and 
        integrated federal program to address these research, 
        development, and technology needs, including--
                    ``(A) the application of Federal Government 
                resources, including recommendations for the allocation 
                and prioritization of Federal funds;
                    ``(B) interagency management and coordination 
                mechanisms;
                    ``(C) the establishment of partnerships between 
                private corporations and Federal agencies or Federally 
                funded entities;
                    ``(D) information and technology sharing and 
                coordination mechanisms among public, private, 
                academic, not-for-profit, and international 
                institutions;
                    ``(E) the use of incentives to promote private 
                sector participation; and
                    ``(F) the adjustment of Federal regulatory 
                requirements to promote private sector innovation.
            ``(6) The identification of potential liability concerns 
        stemming from distribution of rapidly-developed priority 
        countermeasures under emergency conditions and a proposal for 
        regulatory or legislative approaches to eliminating these 
        concerns.
            ``(7) A proposal for managing the transfer of new 
        technologies and associated intellectual property rights.
    ``(c) Considerations.--In developing the national strategy under 
subsection (a), the Secretaries shall consider--
            ``(1) the research, development, and technology needs and 
        clinical research needs of the entire pathogen identification 
        to priority countermeasures discovery, development, production, 
        and approval process, including--
                    ``(A) initial identification and characterization 
                of a pathogen or toxin, including the identification of 
                any genetic or other manipulations;
                    ``(B) priority countermeasures discovery;
                    ``(C) pre-clinical testing and evaluation of 
                priority countermeasures;
                    ``(D) safety and efficacy animal testing, including 
                the needs for approval under emergency conditions and 
                accelerated approval of new priority countermeasure 
                under the final rule `New Drug and Biological Drug 
                Products; Evidence Needed to Demonstrate Effectiveness 
                of New Drugs When Human Efficacy Studies Are Not 
                Ethical or Feasible' published in the Federal Register 
                on May 31, 2002 (67 Fed. Reg. 37988);
                    ``(E) safety and efficacy human testing, including 
                mechanisms for the conduct of clinical trials under 
                emergency conditions;
                    ``(F) research-scale and full production-scale 
                manufacturing, including biologics manufacturing 
                sciences; and
                    ``(G) the approval of priority countermeasure under 
                emergency conditions;
            ``(2) the potential importance of advanced technologies 
        such as automation, computer modeling and simulation, 
        bioinformatics, pharmacogenomics, and bioengineering techniques 
        for manufacturing;
            ``(3) the availability of sufficient manufacturing capacity 
        for priority countermeasures production to meet potential 
        public demand under emergency conditions; and
            ``(4) the current state of national and international 
        collaborative research networks and applications to facilitate 
        and encourage the rapid and coordinated development and sharing 
        of laboratory and clinical research planning and results.
    ``(d) Authority to Contract.--The Secretary of Homeland Security, 
after consultation with the Secretaries of Health and Human Services 
and Defense and the working group established under section 319F(a) of 
the Public Health Service Act, may contract with any one or more for-
profit or non-profit firm or institution to conduct the necessary 
research and analysis needed to complete any one or more of the 
elements described in subsection (b) of the report required in this 
section, provided the considerations described in subsection (c) are 
met.
    ``(e) Definitions.--In this section:
            ``(1) The term `emergency conditions' refers to a 
        declaration of emergency under section 564 of the Federal Food, 
        Drug, and Cosmetic Act.
            ``(2) The term `pathogen identification' means the point in 
        time in which a specific agent that can be reasonably assumed 
        to be the cause of (or has the potential to be the cause of) an 
        infectious disease or toxin-induced syndrome has been 
        identified and partially or wholly characterized 
        scientifically.
            ``(3) The term `priority countermeasure' has the same 
        meaning given such term in section 319F(h) of the Public Health 
        Service Act.
    ``(f) Authorization of Appropriations.--For the purpose of carrying 
out this section, there is authorized to be appropriated $10,000,000 
for fiscal year 2005.''.

SEC. 4. CLINICAL RESEARCH UNDER EMERGENCY CONDITIONS.

    (a) In General.--Not later than 180 days after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
establish a system for the rapid establishment of clinical research 
programs to examine the safety and efficacy of new or existing 
treatments for novel, unknown, or bioengineered pathogens or toxins. 
The Secretary shall also provide the means for rapid dissemination of 
results and recommendations to clinicians nationwide.
    (b) Emergency Fund.--A fund is authorized to be established for 
use, at the discretion of the Secretary, solely for the support of 
clinical research as described in subsection (a).

SEC. 5. INTERAGENCY WORKING GROUP.

     Section 319F(a) of the Public Health Service Act, as amended by 
Public Law 107-188, is amended--
            (1) by inserting ``the Secretary of Homeland Security,'' 
        after ``in coordination with the'';
            (2) by redesignating subparagraphs (D) through (L) as 
        subparagraphs (E) through (M), respectively; and
            (3) by inserting after subparagraph (C) the following 
        subparagraph:
                    ``(D) development of a national strategy to achieve 
                dramatic reductions in the timeframe from the 
                identification of a pathogen to the development and 
                approval for human use under emergency conditions of 
                priority countermeasures against a novel, unknown, or 
                engineered pathogen or toxin;''.

SEC. 6. DEVELOPING THE CAPABILITY FOR RAPID BIODEFENSE COUNTERMEASURE 
              DEVELOPMENT.

    (a) Research.--Section 319F(h)(1) of the Public Health Service Act, 
as amended by Public Law 107-188, is amended--
            (1) in subparagraph (C), by striking ``and'' after the 
        semicolon;
            (2) by redesignating subparagraph (D) as subparagraph (E); 
        and
            (3) by inserting after subparagraph (C) the following 
        subparagraph:
                    ``(D) the development of a capability to rapidly 
                identify, develop, produce, and approve for human use 
                under emergency conditions priority countermeasures 
                against a novel, unknown, or engineered pathogen or 
                toxin; and''.
    (b) Research and Development at the Department of Defense.--Section 
1601(a) of the National Defense Authorization Act for Fiscal Year 2004 
(Public Law 108-136) is amended by adding at the end the following: 
``The program shall also include research, development, and procurement 
to provide the Federal Government with the capability to rapidly 
identify, develop, produce, and approve for human use under emergency 
conditions priority countermeasures against a novel, unknown, or 
engineered pathogen or toxin, and for which no existing countermeasure 
has been determined to be safe or efficacious.''.
    (c) Research and Development at the Department of Homeland 
Security.--Title III of the Homeland Security Act of 2002, as amended 
by section 3 of this Act, is amended by inserting after section 304A 
the following section:

``SEC. 304B. DEVELOPING THE CAPABILITY FOR RAPID BIODEFENSE 
              COUNTERMEASURE DEVELOPMENT.

    ``The Secretary, in collaboration with the Secretaries of Defense 
and Health and Human Services, shall carry out a program for research, 
development, and procurement to provide the Federal Government with the 
capability to rapidly identify, develop, produce, and approve for human 
use under emergency conditions priority countermeasures against a 
novel, unknown, or engineered pathogen or toxin, and for which no 
existing countermeasure has been determined to be safe or 
efficacious.''.
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