Drug, biologic approvals up, review times down

FDA Consumer, April, 1997

A record-setting 139 drugs and biological products were approved by FDA in 1996--an increase of 63 percent over the number approved in 1995.

FDA attributed the increase to the Prescription Drug User Fee Act five-year program, in which the agency uses fees paid by manufacturers to shorten drug review and approval times. Median approval times in 1996 were 15.4 months for drugs and 14.9 months for biologics, down from 16.5 months and 17.6 months, respectively, in 1995.

Fifty-three of the drugs approved were new molecular entities. They included three drugs for HIV (the virus that causes AIDS), two for cancer, and one each for asthma, Alzheimer's disease, and multiple sclerosis.

Eight of the licensed biological products were first-time entities. Major biological products licensed in 1996 included Respigam, the first medication to protect infants against serious respiratory syncytial virus disease; Avonex, the second interferon product for multiple sclerosis; and Verluma, a diagnostic imaging agent for determining at one time the extent of small cell lung cancer in different parts of the body. Also of note were five new HIV test kits.