FDA’s Procedures on AZT Approval

Your editorial “Get It to the Right People Faster,” (Jan. 18) is mistaken in accusing the Food and Drug Administration of needlessly delaying the approval of zidovudine (AZT) to treat people at earlier stages of HIV infection. The editorial even referred incorrectly to the agency as the “Federal Drug Administration.”

Even many of the FDA’s severest critics recognize the circumstances surrounding this case and have not blamed the agency for any alleged delays. They realize that the agency, by law, cannot approve new uses for a drug until the drug’s sponsors provide clinical data showing that a drug is safe and effective for its proposed use in its intended population. Without this clinical evidence, the agency cannot reliably review or approve new indications for a drug.

Would the editorial’s authors prefer the agency to callously approve drugs without this knowledge, and thereby subject large numbers of patients to unknown risks?

FDA is committed to expediting its review and approval once it has the necessary evidence to show safety and efficacy. Just this month, for example, FDA approved new lower dose recommendations for zidovudine after taking less than a month to review the clinical data that had been submitted on this new dose.

As a public institution, FDA expects, and even welcomes, informed criticism of its policies and action.

But, when a publication of the stature of The Times chooses to use the agency as a convenient scapegoat on such an important issue, without bothering to get the facts straight, it serves no useful purpose to people with AIDS and the rest of the public.

JEFFREY A. NESBIT

Associate Commissioner

for Public Affairs, FDA

Rockville, Md.