107th Congress

Microbicide Development Act of 2001
H.R. 2405 and S. 1752

Background

Representative Constance A. Morella (R-MD) introduced H.R. 2405, the Microbicide Development Act of 2001, to amend the Public Health Service Act with respect to facilitating the development of microbicides to prevent transmission of HIV and other sexually transmitted diseases (STDs). This legislation underscores the Congresswoman's continuing interest in development of microbicides to prevent transmission of these diseases, which she has expressed through similar legislation in the last several Congresses. Following discussions with her colleagues in the Senate, Senator Jon S. Corzine (D-NJ) introduced S. 1752, a bill with the same name but containing modifications to certain requirements for coordination of National Institutes of Health (NIH) microbicide research.

Provisions of the Legislation/Impact on NIH

H.R. 2405

H.R. 2405 would require the Director of the National Institute of Allergy and Infectious Diseases (NIAID) to

• Expand, intensify, and coordinate Institute research activities on the development of microbicides to prevent transmission of HIV and other STDs and coordinate relevant activities among all appropriate NIH Institutes and Centers (ICs).
• Develop, in consultation with the Director of the Office of AIDS Research (OAR), other ICs, the microbicide research community, and health advocates, a comprehensive research plan for the conduct and support of research and development of microbicides, with an annual review and revision (as appropriate) of the plan. The plan must 1) identify current NIH research and development (R&D) activities on microbicides, including descriptions of each current grant and contract mechanism explicitly designed to facilitate microbicide research, and 2) describe microbicide R&D opportunities over a 5-year period beginning 6 months after enactment of the act, including professional judgment funding projections, descriptions of objectives, and so forth. The initial plan is to be developed not later than 6 months after the date of enactment of the act.
• Submit the initial plan to the Director of NIH for transmission to the President and the Congress.
• Establish a program to support research to develop microbicides, including expansion and intensification of the conduct and support of basic research on mechanisms of infection, development of animal models, formulation and delivery of models, research on targeted designs, manufacture of candidate projects for animal and human testing, conduct of HIV incidence and microbicide feasibility studies, and behavioral research on use, acceptability, and adherence.
• Establish a Microbicide Research Branch in the Institute's Division of AIDS (within the Vaccine and Prevention Research Program).
• Make, in consultation with its advisory council and with the Director of OAR, grant or contract awards to public and nonprofit private entities for the development and operation of not less than four new multidisciplinary research centers to conduct microbicide research.
• Submit, within 1 year of submission of the initial plan, a research plan to the House and Senate authorizing committees.
• Consult with the Director of the Centers for Disease Control and Prevention (CDC) and representatives of the U.S. Agency for International Development when developing the research plan to ensure consideration of relevant research activities of these Agencies.

In addition, H.R. 2405 would require the Secretary of Health and Human Services (HHS), acting through the Director of CDC, to expand, intensify, and coordinate microbicide activities at the multidisciplinary research centers. In carrying out these activities, the Secretary of HHS would be authorized to make grants to public and nonprofit private entities for research, including behavioral research, developing and characterizing domestic and international populations appropriate for phase I, II, and III clinical trials of candidate topical microbicides, phase I and II safety and acceptability clinical trials, and phase III efficacy trials.

S. 1752

S. 1752 contains provisions very similar to those contained in H.R. 2405; however, the bill would establish the Director of OAR as the lead for expansion and coordination of NIH microbicide research, rather than the Director of NIAID. Specifically, S. 1752 would require the Director of OAR to

• Expand, intensify, and coordinate the activities of the Institutes with respect to research on the development of microbicides to prevent the transmission of HIV and other STDs and coordinate these activities among all appropriate Institutes and components of NIH having such related responsibilities
• Expedite, in consultation with the Director of NIAID, implementation of the 5-year strategic plan for the conduct and support of microbicide research and development. The plan would have the same requirements as contained in H.R. 2405 but must describe microbicide R&D opportunities over a 5-year period beginning 3 months, rather than 6 months, after enactment of the act, including professional judgment funding projections, descriptions of objectives, roles of the Institutes involved, staffing and resource needs, and so forth.
• Submit the initial plan to the Director of NIH for transmission to the President and the Congress
• Establish a program to support research to develop microbicides, including expansion and intensification of the conduct and support of basic research on mechanisms of infection, development of animal models, formulation and delivery of models, research on targeted designs, manufacture of candidate projects for animal and human testing, conduct of HIV incidence and microbicide feasibility studies, and behavioral research on use, acceptability, and adherence
• Submit, within 1 year of submission of the initial plan, a research plan to the House and Senate authorizing committees.

Other provisions of S. 1752 are as follows:

• The Director of NIAID must establish a Microbicide Research Branch in the Institute's Division of AIDS (within the Vaccine and Prevention Research Program).
• The Director of NIH, rather than the Director of NIAID, must make grant or contract awards to public and nonprofit private entities for the development and operation of not less than four new multidisciplinary research teams, rather than centers, to conduct microbicide research.
• The Director of OAR must consult with the Director of CDC and representatives of the U.S. Agency for International Development when developing the research plan to ensure consideration of relevant research activities of these Agencies.

Like H.R. 2405, S. 1752 also would require the Secretary of HHS, acting through the Director of CDC, to expand, intensify, and coordinate microbicide activities at the multidisciplinary research centers. [Teams, rather than centers, are mentioned above.] In carrying out these activities, the Secretary of HHS would be authorized to make grants to public and nonprofit private entities for research, including behavioral research, developing and characterizing domestic and international populations appropriate for phase I, II, and III clinical trials of candidate topical microbicides, phase I and II safety and acceptability clinical trials, and phase III efficacy trials.

Status and Outlook

H.R. 2405 was introduced on June 28, 2001, and was referred to the House Committee on Energy and Commerce. On July 16, 2001, the bill was referred to the Subcommittee on Health of the House Committee on Energy and Commerce. S. 1752 was introduced on November 30, 2001, and was referred to the Senate Committee on Health, Education, Labor and Pensions.