109th Congress

Microbicide Development Act

S. 550, H.R. 3854

Background

The role of and need for microbicides to prevent the spread of sexually transmitted diseases, in particular HIV/AIDS, have long been recognized by some Members of Congress. Beginning in 1991 and continuing until she left Congress in 2002, former Representative Connie A. Morella (R-MD) introduced legislation on this topic to express her interest in the development of microbicides to prevent the transmission of these diseases. During the 107th Congress, she was joined in her pursuit of such legislation by former Senator Jon S. Corzine (D-NJ), who introduced his own microbicide bill. Neither bill, however, received final action in the 107th Congress. In the first session of the 108th Congress, Senator Corzine introduced a revised version of his earlier legislation. Although no other bills specifically targeting microbicide development were introduced in the 108th Congress, a number of global HIV/AIDS and foreign assistance bills that were introduced contained provisions relating to the need for microbicides.

Senator Corzine’s interest in microbicide development did not diminish, as evidenced by his introduction of a slightly modified version of his earlier legislation in the first session of the 109th Congress. In his introductory remarks, Senator Corzine said that the legislation would encourage new investments in microbicide research at the National Institutes of Health (NIH), noting that such research is currently conducted with no single line of administrative accountability or specific funding coordination. (In actuality, NIH provides considerable resources for microbicide research, which is coordinated by the NIH Office of AIDS Research [OAR].) Senator Corzine was joined in his efforts on this issue by Representative Christopher Shays (R-CT), who introduced an almost identical bill after the August 2005 recess.

Provisions of the Legislation/Impact on NIH

S. 550 would have required the Director of OAR to:

• Expedite the development and implementation of a Federal microbicide research and development strategic plan. The plan would have been reviewed annually and revised, as appropriate, to prioritize funding and activities based on scientific urgency.
• Coordinate the implementation, review, and prioritization of elements of the strategic plan with other Federal officials, including the Director of the Centers for Disease Control and Prevention and the Administrator of the U.S. Agency for International Development, the microbicide research community, and health advocates
• Expand, intensify, and coordinate the activities of all appropriate NIH research components with respect to research on the development of microbicides to prevent the transmission of HIV and other sexually transmitted diseases
• Prepare and submit, within 6 months of enactment and annually thereafter, a report to Congress on Federal microbicide research and development implementation strategies. The report would have been required to include a description of microbicide research and development activities conducted and supported by the Federal Government; a summary and analysis of expenditures made by the Director of OAR in the preceding year for microbicide-specific research and development, including basic research, preclinical product development, clinical trials, and process development and production; a description and evaluation of progress made; and a review of any scientific and programmatic obstacles.

Provisions of S. 550 would have also required the Director of the National Institute of Allergy and Infectious Diseases to:

• Establish a clearly defined microbicide research unit within the Institute’s Division of AIDS to conduct microbicide research and development
• Ensure that there are sufficient numbers of employees dedicated to carrying out the activities of the unit
• Assign priority to ensuring sufficient funding and support for the integration of basic science and clinical research, with particular emphasis on the implementation of clinical trials leading to product licensure

H.R. 3854 contained NIH research provisions that were identical to those found in S. 550; modest differences existed in provisions for other agencies mentioned in the bill.

Status and Outlook

S. 550 was introduced by Senator Corzine on March 8, 2005, and was referred to the Senate Committee on Health, Education, Labor and Pensions. The bill had 17 cosponsors. No further action occurred on this legislation during the 109th Congress.

H.R. 3854 was introduced by Representative Shays on September 21, 2005, and was referred to the House Committees on Energy and Commerce and on International Relations. It had 52 cosponsors. No further action occurred on this legislation during the 109th Congress.