Monday, August 22, 1994
By Steve Usdin
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 FDA include decisions about how mature the development process should be before urgently needed drugs are approved under an accelerated procedure, regulation of post-approval trials, and the best way to incorporate surrogate markers in light of shifting scientific knowledge. All of these questions will be on the agenda of the upcoming Antiviral Drugs Advisory Committee meeting, David Feigal, director of the FDA's division of antiviral drug products, told BioCentury.
Feigal said the meeting will be designed for maximum interaction among committee members and attendees. "What we are going to do is try to be much more interactive with the audience and rather than have a single hour for open public hearing, we will look for the opportunity to have people make comments on the different parts of the meeting," he said.