FDA's perspective on rapid review for AIDS drugs

WASHINGTON - FDA officials, including Commissioner David Kessler and David Feigal, director of the antiviral drug products division, reaffirmed the agency's commitment to rapid approval of AIDS drugs and provided some clues about the future course of accelerated review at a day-and-a-half-long meeting of the Antiviral Drugs Advisory Committee last week.

Outlining the FDA's requirements for AIDS trials, Feigal said, "We certainly still find a very key role for surrogates in drug development. They're very important and are useful early-on in terms of drug screening, in terms of dose finding, in terms of Phase I, II studies, and they are important for the studies that are important for accelerated approval."