Focusing debate on AIDS drugs
WASHINGTON - The FDA's fast track and parallel track approval processes for AIDS drugs will come under close scrutiny this fall in several advisory committee meetings, starting with a gathering of the Antiviral Drugs Advisory Committee on Sept. 12-13.
The meetings will reflect the multifaceted nature of AIDS drug discovery and development, with scientific, ethical, and social issues vying for attention. The shifting attitudes of a vocal segment of the HIV community towards early adoption of treatments and the structure of clinical trials will be on the agenda, as will the interests of biotechnology and pharmaceutical companies that have invested heavily in AIDS research and could lose incentives for further research if FDA radically changes approval policies.
Some AIDS activists, disappointed with the lack of progress in developing treatments and the slow pace of clinical optimization of regimens for the approved nucleoside analogs such as AZT, are calling for a slowing of the fast track.
The scientific and regulatory issues facing the