Monday, Feb. 13, 1989
Help on The Way
The Food and Drug Administration announced last October that it would allow promising but unproven treatments for AIDS to move onto the market more swiftly than other new drugs. Last week the agency made good on that promise. It said it would approve an aerosol drug, pentamidine, for treatment of a deadly form of pneumonia that is a leading killer of AIDS patients.
The move is a major departure from the FDA's traditional practice of requiring rigorous tests, which can take up to seven years, to establish a drug's safety and effectiveness before granting approval. Black-market versions of the aerosol pentamidine have circulated for years, but the treatment has been studied in controlled clinical tests only since July 1987. The change of policy came after organized protests by AIDS patients, who argued that the Government's stringent regulations were blocking access to potentially lifesaving medicines.