109th Congress

Attacking Viral Influenza Across Nations

S. 969/H.R. 3369, S. 1821/H.R. 4062, S. 1828, S. 1873, S. 1880, H.R. 4245, S. 2564, H.R. 5533, S. 3678

Background

In October 2004, Congress and the Nation learned that one of the three manufacturers of the influenza vaccine would not be able to fulfill its production quota due to problems at its manufacturing facilities in England. As a result, there was concern that the number of available doses of influenza vaccine for the 2004–2005 season would fall far short of the projected number needed. Added to this concern was the fear that a pandemic influenza outbreak caused by an avian influenza virus could be on the horizon. This situation has spurred hearings, briefings for Members of Congress and staff, and the introduction of legislation.

Since January 2005, 10 congressional hearings have been held in which an expert from the National Institutes of Health (NIH) participated. Members of Congress introduced a variety of bills aimed at providing incentives for companies to become involved in influenza vaccine production and ensuring that adequate vaccine would be available for future influenza seasons. By the end of the 109th Congress, 11 bills (S. 969, H.R. 3369, S. 1821, H.R. 4062, S. 1828, S. 1873, S. 1880, H.R. 4245, S. 2564, H.R. 5533, and S. 3678) targeting pandemic influenza and containing research provisions to combat it had been introduced. Of these bills, only S. 3678 received final action.

In addition, liability protection provisions for pandemic and epidemic products and security countermeasures were included in the Department of Defense (DOD) Appropriations Act, 2006 (P.L. 109-148). These provisions will provide protection for a person (defined as including “an individual, partnership, corporation, association, entity, or public or private corporation, including a Federal, State or local government agency or department”) from “suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure if a declaration (by the Secretary of Health and Human Services) has been issued with respect to that countermeasure.” These provisions will also establish a covered countermeasure compensation process fund to provide compensation to eligible individuals for covered injuries. Congressional leadership added these provisions to the DOD conference report, rather than including them in the conference report for appropriations legislation for the U.S. Departments of Labor, Health and Human Services (DHHS), and Education, in order to complete action on the bill.

NIH, acting primarily through its National Institute of Allergy and Infectious Diseases (NIAID), has performed extensive research on the development and clinical evaluation of vaccines, antivirals, and diagnostics to control human influenza strains. This research has extended to include research on the H5N1 virus strain currently infecting fowl and migratory bird populations around the world and humans in Azerbaijan, Cambodia, China, Djibouti, Egypt, Indonesia, Iraq, Thailand, Turkey, and Vietnam. This strain is thought to have the potential for causing a pandemic if the virus mutates to infect humans more efficiently. This research also includes vaccine dose-sparing studies of intramuscular versus intradermal routes of administration, development of improved antiviral agents and the evaluation of adjuvants to increase the effectiveness of these products, and basic and applied research to develop alternatives to using chicken eggs for vaccine production. Other DHHS agencies are also involved in a broad range of surveillance, detection, and readiness and response activities to address a potential pandemic influenza outbreak.

Provisions of the Legislation/Impact on NIH

S. 969/H.R. 3369—The Attacking Viral Influenza Across Nations Act of 2005

Provisions of S. 969 and H.R. 3369 would have required the Director of NIH, in collaboration with the Director of the Centers for Disease Control and Prevention (CDC), to expand and intensify human and animal research on influenza related to vaccine development and manufacture, including strategies to increase immunological response, develop prophylactic and therapeutic antivirals, inhibit side effects and promote drug safety of antivirals and vaccines in subpopulations, explore alternate routes of delivery, develop more efficient methods of viral testing and subtype determinations, and other actions as deemed appropriate. The Director of NIH would have also been required to expand and intensify research on past pandemics in order to better understand pandemic epidemiology, transmission, protective measures, high-risk groups, and other lessons that may be applicable to future pandemics.

S. 1821/H.R. 4062—The Pandemic Preparedness and Response Act

Research provisions in S. 1821 and H.R. 4062 would have required the Director of NIH, in collaboration with the Director of CDC, to expand and intensify human and animal influenza research, including research on vaccine development and manufacture, effectiveness of inducing heterosubtypic immunity, antigen-sparing studies, antiviral development, drug safety, alternative routes of delivery, modes of transmission, and other areas determined by the Director of NIH.

S. 1828—The Influenza Vaccine Security Act of 2005

Research provisions in S. 1828 would have required that 1) NIAID solicit proposals for research into improved technologies for influenza vaccine development, 2) the Director of NIAID, acting jointly with the Director of the Institute’s Intramural Program and the Scientific Director of the Vaccine Research Center, review NIAID’s extramural vaccine development research grants to identify research with the potential for providing the Nation with improved technologies for vaccine production that could be marketed in this country within 10 years of enactment of the bill, and 3) the Director of NIAID provide supplementary grant funding for such research. A total of $100,000,000 would have been authorized for each of the fiscal years (FYs) 2007 through 2011.

S. 1873—The 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 Health and Human Services (HHS), acting through the Director of NIH, to establish and award grants to study and validate animal models for chemical, biological, radiological, and nuclear (CBRN) agents or toxins or potential pandemic infectious diseases. The measure would have required the establishment of a separate Biomedical Advanced Research and Development Agency (BARDA) within DHHS to coordinate and oversee activities that support and accelerate qualified countermeasures or qualified pandemic or epidemic product advanced research and development (R&D). This entity 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.

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 DOD and the U.S. Department of Veterans Affairs 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.

H.R. 4245—Influenza Preparedness and Prevention Act of 2005

H.R. 4245 sought to establish a course to quickly develop and purchase vaccines and antivirals, ensure a stockpile of sufficient antivirals to treat 25 percent of the U.S. population and doses of a viable vaccine, and provide limited liability protections for vaccine manufacturers and providers. NIH-related provisions would have required the Director of NIH, in collaboration with the Director of CDC, to expand and intensify human and animal influenza research, including vaccine development and manufacture, effectiveness of inducing heterosubtypic immunity, antigen-sparing studies, antiviral development, drug safety, alternative routes of delivery, modes of transmission, and other areas determined by the Director of NIH.

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

S. 2564 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 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 will 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. 969, a companion bill to H.R. 3369, was introduced by Senator Barack Obama (D-IL) on April 28, 2005, and was referred to the Senate Committee on Health, Education, Labor and Pensions (HELP). No further action occurred on this legislation during the 109th Congress.

H.R. 3369, a companion bill to S. 969, was introduced by Representative Nita M. Lowey (D-NY) on July 20, 2005, and was referred to the House Committees on Resources, on Agriculture, and on Energy and Commerce. The measure had 11 original cosponsors and 4 additional cosponsors. No further action occurred on this legislation during the 109th Congress.

S. 1821, a companion bill to H.R. 4062, was introduced by Senator Harry Reid (D-NV) on October 5, 2005, and was referred to the Senate HELP Committee. No further action occurred on this legislation during the 109th Congress.

S. 1828 was introduced by Senator Hillary Rodham Clinton (D-NY) on October 6, 2005, and was referred to the Senate HELP Committee. No further action occurred on this legislation during the 109th Congress.

H.R. 4062, a companion bill to S. 1821, was introduced by Representative Lowey on October 17, 2005, and was referred to the House Committee on Energy and Commerce. The measure had 31 cosponsors. No further action occurred on this legislation during the 109th Congress.

S. 1873 was introduced by Senator Richard Burr (R-NC) on October 17, 2005, and was referred to the Senate HELP Committee. The measure had four original cosponsors, Senators Michael B. Enzi (R-WY), Chair of the Senate HELP Committee; Judd Gregg (R-NH); Bill Frist (R-TN), Senate Majority Leader; and Lamar Alexander (R-TN). The measure was marked up on October 18 and ordered to be reported out of the Senate HELP Committee with an amendment in the nature of a substitute. Senator Elizabeth Dole (R-NC) was added as a cosponsor 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 Edward M. Kennedy on October 17, 2005, for himself and Senators Clinton, Obama, Tom Harkin (D-IA), Barbara A. Mikulski (D-MD), Jeff Bingaman (D-NM), and Charles E. Schumer (D-NY) and was referred to the Senate HELP Committee. No further action occurred on this legislation during the 109th Congress.

H.R. 4245 was introduced by Representative Jerry Lewis (R-CA) on November 7, 2005, and was referred to the House Committees on Agriculture, on Resources, and on Energy and Commerce. The measure had six original cosponsors, including Representative Ralph Regula (R-OH), Chair of the House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies. 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 Michael J. Rogers (R-MI) 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.