New FDA Commissioner Testifies on AIDS Drugs

On March 6 the new FDA Commissioner David Kessler, M. D., told Senator Edward Kennedy's Labor and Human Resources Committee that the FDA would not obstruct drugs for AIDS or other life- threatening diseases. According to reporter Nick Bartolomeo of the gay newspaper The Washington Blade, Dr. Kessler told the Committee that the FDA had more than 350 applications for testing new AIDS drugs and other treatments -- which Dr. Kessler described as "the pipeline of things to come." Dr. Kessler also said that "if the mission [of the FDA] is to protect public health, the Agency has an obligation to reach for the data. We can't sit back passively." A short article on the hearing appeared in the Blade on March 15.

Dr. Kessler also discussed conditional approval, a proposal to allow earlier drug approval on condition that the developer continue scientific testing. (Note: such agreements have been made in the past, but often broken by the developer. New legislation might be needed for conditional approval, since at present it is not clear that the FDA has the authority to enforce such agreements.)

An article on the hearing in the March 17 San Francisco Examiner mentioned the testimony on avoiding delays in approval of important new drugs. The Examiner article focused primarily on Kessler's call for stronger enforcement to prevent abuses such as fraudulent data submitted for generic drugs, or misleading drug claims in advertisements directed to the public.