109th Congress

Protecting America in the War on Terror

S. 3, S. 975, S. 1873, S. 1880, S. 2564, H.R. 5533, S. 3678

Background

The potential for biological, chemical, radiological, and nuclear attacks on the United States and the Nation’s response to such threats continue to be of significant interest to the 109th Congress, as they were for the past two Congresses. Following enactment of the Project BioShield Act of 2004 (P.L. 108-276) on July 21, 2004, some Members of Congress said that the law neither addresses all the relevant concerns nor provides sufficient incentives to increase private-sector participation in the development of biodefense countermeasures and tools.

In response, the Republican leadership introduced S. 3, the Protecting America in the War on Terror Act of 2005, at the start of the 109th Congress. Title 1 of the legislation, the Biopreparedness Act of 2005, was said to be 1 of the Senate Republicans’ top 10 legislative priorities for the 109th Congress. Provisions were designed to build on Project BioShield to ensure the development of much-needed vaccines and other products to respond to biological, radiological, and nuclear attacks and to expand access to these products.

Senator Joseph I. Lieberman (D-CT) introduced S. 975, the Project BioShield II Act of 2005, which would have provided incentives to increase research by the private sector for the development of medical countermeasures against biological, chemical, nuclear, and radiological weapons and infectious disease outbreaks. With similar aims in mind, Senator Richard Burr (R-NC) introduced S. 1873 to prepare and strengthen the biodefenses of the United States against deliberate, accidental, and natural outbreaks of illness. Although S. 1873 received Committee action, it was replaced by a subsequent bill (S. 2564) introduced by Senator Burr on the same topic and bearing the same name. S. 1880 was introduced by Senator Edward M. Kennedy (D-MA) to amend the Public Health Service Act to enhance biodefense and pandemic preparedness activities. H.R. 5533, a related, although not identical, bill containing many of the same provisions as S. 2564, was introduced by Representative Michael J. Rogers (R-MI). Most recently, Senator Burr introduced S. 3678, which focuses on enhancing public health and medical preparedness and was amended to contain pandemic/biodefense provisions. S. 3678 was the only bill to receive final action and was signed into law by the President as P.L. 107-88.

Provisions of the Legislation/Impact on NIH

S. 3—Protecting America in the War on Terror Act of 2005

Provisions relating to the National Institutes of Health (NIH) in Title 1 of S. 3 would have required the Secretary of Health and Human Services (HHS), in coordination with the Directors of the National Institute of Allergy and Infectious Diseases and the Centers for Disease Control and Prevention, to establish and award grants for the study of physiological responses of certain animal species to bioterrorism agents and other infectious agents. Other provisions would have expanded the definition of countermeasures covered by the Project BioShield Act of 2004, enhanced the availability of international and private-sector financing for the procurement or development of qualified countermeasures, provided patent incentives and protections for countermeasures and vaccine research, provided liability protections, and required the Secretary of HHS to establish a Public Health Workforce Loan Repayment Program.

S. 975—Project Bioshield II Act of 2005

Among its many provisions, S. 975 would have required the establishment of 1) a Biomedical Advanced Research and Development Agency (BARDA) within the U.S. Department of Health and Human Services (DHHS) to coordinate and oversee activities that support and accelerate advanced research and development (R&D) of qualified countermeasures or pandemic or epidemic products, 2) a National Biodefense Advisory Board to provide the Secretary of HHS with expert advice and guidance on threats, challenges, and opportunities created through biology and life sciences advances and threats from naturally occurring infectious diseases and chemical, biological, radiological, and nuclear (CBRN) threats, and 3) a National Pathology Center at NIH, which would assume certain functions of the Armed Forces Institute of Pathology.

S. 1873—Biodefense and Pandemic Vaccine and Drug Development Act of 2005

S. 1873 would have provided orphan drug market exclusivity for countermeasure products and liability protections for pandemic and epidemic products and countermeasures and would have required the Secretary of HHS, acting through the Director of NIH, to establish and award grants to study and validate animal models for CBRN agents or toxins or potential pandemic infectious diseases. The measure would have also required the establishment of a separate BARDA within DHHS to coordinate and oversee activities that support and accelerate qualified countermeasures or qualified pandemic or epidemic product advanced R&D. This agency would have been responsible for directing and coordinating collaboration among DHHS entities, other Federal agencies, relevant industries, academia, and other individuals with respect to advanced R&D. Such a provision would have duplicated existing authorities for some of the entities involved. During final action on S. 3678, certain provisions of S. 1873 were added to that legislation.

S. 1880—National Biodefense and Pandemic Preparedness Act of 2005

Among its many provisions, S. 1880 would have required the establishment of a National Institute of Pathology (NIP), whose Director would have been appointed by the Secretary of HHS but would have reported directly to the Director of NIH. The Institute would have been responsible for conducting and supporting research, education, training, and other programs with respect to the science and clinical practice of pathology; maintaining a pathology tissue repository; and providing pathology consultation services. Provisions would have authorized the Director of NIP to enter into memorandums of understanding with officials at the U.S. Departments of Veterans Affairs and of Defense to provide relevant consultations, education, or training if requested by the agency’s Secretary. Provisions of the legislation would have also transferred the Armed Forces Institute of Pathology to NIP.

S. 2564—Biodefense and Pandemic Vaccine and Drug Development Act of 2006

The measure would have required the establishment of:

• A BARDA within DHHS to 1) coordinate and oversee activities that support and accelerate advanced R&D of qualified countermeasures or pandemic or epidemic products, 2) facilitate collaboration among DHHS components, other Federal agencies, relevant industries, academia, and other individuals, 3) promote countermeasure and product advanced R&D, 4) facilitate contacts between interested persons and individuals authorized by the Secretary of HHS to provide advice regarding Federal Food, Drug, and Cosmetic Act requirements, and 5) promote innovations to reduce the time and cost of countermeasure and product advanced R&D
• A National Biodefense Science Board to advise the Secretary of HHS on current and future trends, challenges, and opportunities presented by biotechnology and genetic engineering with respect to diseases and CBRN agents. At the Secretary’s request, the Board would have reviewed and considered any information and findings received from the working groups established in prior sections of the Act and provided recommendations and findings for expanded, intensified, and coordinated biodefense R&D activities.
• A DHHS strategic plan for qualified countermeasure research, including development and procurement efforts to 1) integrate biodefense and emerging infectious disease requirements with advanced R&D, strategic initiatives for innovation, and the procurement of qualified products, 2) guide the R&D of qualified products against CBRN threats and emerging infectious diseases conducted and supported by DHHS, and 3) guide the procurement of qualified countermeasures and products. This plan would have been announced publicly.
• A Biodefense Medical Countermeasure Development Fund, which would have been authorized at $340,000,000 for fiscal year (FY) 2007, with additional authorizations of $160,000,000 for FY 2007, $500,000,000 for FY 2008, and such sums as may have been necessary for FY 2009–2012, rather than using funds provided for Project BioShield activities

S. 2564 would have also provided orphan drug market exclusivity for countermeasure products and pandemic and epidemic products and countermeasures and would have required the coordination of collaboration among DHHS and other Federal agencies, relevant industries, academia, and other individuals through working groups and meetings.

H.R. 5533—Biodefense and Pandemic Vaccine and Drug Development Act of 2006

H.R. 5533 contained BARDA provisions that were similar to those in S. 2564; however, authorizations of appropriations for the Biodefense Medical Countermeasure Development Fund differed significantly. H.R. 5533 would have provided $1,070,000,000 to be authorized for FY 2006–2008 for the Fund, in addition to amounts that otherwise would have been available for this purpose.

S. 3678—Pandemic and All-Hazards Preparedness Act

As introduced, S. 3678 would provide for enhancements to the public health and medical preparedness and response functions of DHHS and the establishment of a National Health Security Strategy. The bill, as amended and passed by both the House and Senate, incorporates provisions from S. 1873. Of note are provisions that require the establishment within DHHS of a BARDA as the single point of authority in the Federal Government for civilian medical countermeasure advanced R&D.

The BARDA will 1) coordinate activities that support and accelerate advanced R&D of qualified countermeasures or pandemic or epidemic products, 2) facilitate collaboration among DHHS components, other Federal agencies, relevant industries, academia, and other individuals, 3) promote countermeasure and product advanced R&D, 4) facilitate contacts between interested persons and the offices or employees authorized by the Secretary of HHS to provide advice regarding Federal Food, Drug, and Cosmetic Act requirements, and 5) promote innovations to reduce the time and cost of countermeasure and product advanced R&D. Unlike earlier versions of the bill, $1,070,000,000 is authorized for FY 2006–2008 for the Biodefense Medical Countermeasure Development Fund that will be established to carry out this activity. Language stating that these sums will be in addition to amounts otherwise available for this purpose was not included in the final legislation.

Like S. 2564, S. 3678 will require the development of a strategic plan for countermeasure R&D and procurement, with the added requirement that the Secretary of HHS update and incorporate this plan as part of the National Health Security Strategy required by this Act. Like H.R. 5533, this measure does not include orphan drug market exclusivity provisions, as did S. 2564.

Amended provisions of S. 3678 also require that the National Science Advisory Board for Biosecurity, when requested by the Secretary of HHS, provide other Federal agencies with advice, guidance, or recommendations on curriculum and training requirements for workers in maximum containment biological laboratories and conduct periodic evaluations of these laboratories’ capacity to assess the need for increases. Provisions also call for the establishment of a National Biodefense Science Board to provide expert advice and guidance to the Secretary on scientific, technical, and other matters of special interest to DHHS regarding current and future biological, chemical, radiological, and nuclear threats, whether naturally occurring, accidental, or deliberate.

In addition, S. 3678 provides clarification of countermeasures covered by Project BioShield, enhanced flexibility for procurement of countermeasures, revitalization of the Commissioned Corps, and enhanced public health and medical preparedness and functions at DHHS. It also facilitates the tracking and distribution of federally purchased influenza vaccine.

Status and Outlook

S. 3 was introduced by Senator Judd Gregg (R-NH) on January 24, 2005, for himself and Senators Bill Frist (R-TN), Jeff Sessions (R-AL), Mike DeWine (R-OH), George Allen (R-VA), and Rick Santorum (R-PA) and was referred to the Senate Committee on Finance. No further action occurred on this legislation during the 109th Congress.

S. 975 was introduced by Senator Lieberman on April 29, 2005, for himself and Senators Orrin G. Hatch (R-UT) and Sam Brownback (R-KS) and was placed on the Legislative Calendar. A hearing to discuss concepts in this legislation was held on July 21 before the Senate Health, Education, Labor and Pensions (HELP) Subcommittee on Bioterrorism and Public Health Preparedness. No further action occurred on this legislation during the 109th Congress.

S. 1873 was introduced by Senator Burr on October 17, 2005, for himself and Senators Lamar Alexander (R-TN), Michael B. Enzi (R-WY), Frist, and Gregg and was referred to the Senate HELP Committee. Markup was held on October 18, and the bill was ordered to be reported out of the Senate HELP Committee with an amendment in the nature of a substitute. One additional cosponsor, Senator Elizabeth Dole (R-NC), was added on October 19. No further action occurred on this legislation during the 109th Congress, although certain provisions were incorporated into S. 3678.

S. 1880 was introduced by Senator Kennedy on October 17, 2005, for himself and Senators Tom Harkin (D-IA), Barbara A. Mikulski (D-MD), Jeff Bingaman (D-NM), Hillary Rodham Clinton (D-NY), Charles E. Schumer (D-NY), and Barack Obama (D-IL) and was referred to the Senate HELP Committee. No further action occurred on this legislation during the 109th Congress.

S. 2564 was introduced by Senator Burr on April 6, 2006, for himself and Senators Alexander, Enzi, Frist, Gregg, and Dole and was referred to the Senate HELP Committee. No further action occurred on this legislation during the 109th Congress.

H.R. 5533 was introduced by Representative Rogers on June 6, 2006, for himself and Representatives Anna Eshoo (D-CA), Peter Hoekstra (R-MI), and John McHugh (R-NY) and was referred to the House Committee on Energy and Commerce. The measure was marked up on September 19 and ordered to be reported out of the House Committee on Energy and Commerce with an amendment in the nature of a substitute on September 20. H.R. 5533 was considered in the House on September 26 and passed under suspension of the rules. No further action occurred on this legislation during the 109th Congress.

S. 3678 was introduced by Senator Burr on July 18, 2006, for himself and Senators Kennedy, Mikulski, Harkin, Enzi, Gregg, and Frist and was referred to the Senate HELP Committee. The measure was marked up and ordered to be reported out of the Senate HELP Committee on July 19, with the report (S. Rept. 109-319) filed on August 4; certain provisions of S. 1873 were incorporated into S. 3678 during markup. During Senate floor action on December 5, S. 3678 was agreed to with an amendment in the nature of a substitute. S. 3678 was passed by the Senate by unanimous consent that day. The measure was passed by the House under suspension of the rules on December 9. On December 19, the President signed the measure into law as P.L. 109-417.