The role of the FDA in the effort against AIDS.

The Food and Drug Administration has instituted several pro-active measures to expedite the review of treatments, diagnostics, and vaccines for AIDS and related conditions. In particular, the agency has established a special designation--1-AA--for a potential AIDS product which gives top priority to its review. This special expedited review process for AIDS products has provided for greater cooperation between their sponsors and FDA's reviewers. AIDS products also receive prompt consideration for orphan product status--a status providing financial incentives to the developers of treatments for certain rare and complex diseases. FDA's special procedures for AIDS drugs have resulted in several major advances in available AIDS treatments. Foremost among these was the FDA's review and approval of zidovudine (commonly known as AZT) as the first effective palliative for AIDS within 107 days--an agency record. Similarly, the agency quickly evaluated and approved ELISA and Western blot diagnostic kits for detecting the presence of HIV antibody. These test kits have made an important contribution to safeguarding the nation's blood supply. The agency has also instituted new "treatment" investigational new drug regulations to allow earlier pre-approval distribution of promising experimental treatments to patients with immediately life-threatening conditions, including persons with AIDS. Under this system and its earlier prototype, eligible AIDS patients were able to receive pre-approval treatment with zidovudine and trimetrexate (an experimental drug for the treatment of AIDS patients with Pneumocystis carinii pneumonia who have experienced severe adverse reactions using standard approved therapies). The agency has made institutional reforms to effectively streamline the review of candidate AIDS treatments and vaccines. Two new centers within the agency have been established for the processing of drug and biologics. In addition,reviewing divisions have been created within these centers to give specialized attention to drugs and biologics designed to treat AIDS or related conditions.These efforts and the other aforementioned reforms, in part, have lead to the initiation of more than 100 ongoing clinical studies of potential drugs for AIDS and related conditions, as well as the clinical testing of two candidate vaccines against HIV. In other areas, FDA has increased inspections of the manufacturing and processing of condoms and begun a surveillance and sampling program to insure the quality of latex surgical gloves. The agency has worked with other authorities to move against quack AIDS products and to educate the public concerning this health fraud.FDA hopes that through all these efforts it can help researchers in government, academia, and industry advance the development, testing, and review of safe and effective therapies, preventatives,and diagnostics for AIDS and related conditions.