110th Congress

Microbicide Development Act

H.R. 1420, S. 823

Background

The role of and need for microbicides to prevent the spread of sexually transmitted diseases, in particular HIV/AIDS, and to offer women-controlled barriers to infection have long been recognized by selected Members of Congress. Women and girls are said to be the new face of HIV/AIDS and are increasingly affected worldwide; more than half of HIV/AIDS cases are found in women. Beginning in 1991, several long-time Members have introduced microbicide legislation in each Congress, although no action was taken on any of these bills. The bills largely focused on the development of a strategic plan and coordination of effort among the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the U.S. Agency for International Development (USAID), and other appropriate Federal entities. These bills did not acknowledge the existence of an NIH strategic plan for microbicide research or recognition by the Agency of the importance of conducting and supporting relevant research. In actuality, NIH provides considerable resources for microbicide research, which is coordinated by the NIH Office of AIDS Research (OAR). In January 2007, NIH staff updated staff of interested Members on ongoing and planned activities.

During the first session of the 110th Congress, two companion bills were introduced targeting microbicide activities of NIH, CDC, and USAID that would also require coordination with other Federal agencies. In addition to microbicide-specific bills, a number of global HIV/AIDS and foreign assistance bills have been introduced that contain provisions relating to the need for microbicides and efforts to make them more widely available, particularly in developing countries experiencing high rates of HIV infection.

Provisions of the Legislation/Impact on NIH

H.R. 1420 and S. 823 would require the Director of OAR to:

• Expedite the implementation of a Federal microbicide research and development (R&D) strategic plan, which would be 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 agencies, the Director of CDC, the Administrator of USAID, the microbicide R&D 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 R&D implementation strategies. The report must include a description of microbicide R&D 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 behavioral science; and a description and evaluation of the progress made.

In addition, provisions would require 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 R&D
• 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

The bills also contain provisions targeting the activities of CDC and USAID. CDC would be required to fully implement its microbicide agenda to support relevant R&D, including conducting laboratory and behavioral research in preparation for and in support of clinical microbicide trials. The head of USAID’s Office of HIV/AIDS would be directed by the President, in conjunction with other USAID components, to develop and implement a program to support the development of microbicides for the prevention of HIV/AIDS and other diseases and to facilitate wide availability of such products following development.

With respect to NIH activities, H.R. 1420 and S. 823 would codify what is already being done or has been planned by the Agency.

Status and Outlook

H.R. 1420 was introduced by Representative Janice D. Schakowsky (D-IL) on March 8, 2007, and was referred to the House Committee on Energy and Commerce. The bill had 13 original cosponsors, and 51 additional cosponsors have been added. No further action has occurred on this legislation.

S. 823 was introduced by Senator Barack Obama (D-IL) on March 8, 2007, and was referred to the Senate Committee on Health, Education, Labor and Pensions. The bill had 7 original cosponsors, and 11 additional cosponsors have been added. No further action has occurred on this legislation.

April 2008