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FDA Premarket Approval: Process of Approving Ansaid as a Drug

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Report Type Reports and Testimonies
Report Date April 7, 1992
Report No. HRD-92-85
Subject
Summary:

Ansaid, a nonsteroidal anti-inflammatory drug marketed by The Upjohn Company since 1989, is mainly used to treat arthritis. Although Upjohn applied to the Food and Drug Administration (FDA) in 1982 to sell Ansaid, premarket approval was not granted until 1989. Upjohn argues that the 79-month approval period was excessive, citing an average approval time of 26 months for similar drugs. GAO found that during that period, FDA faced the unusual situation of having to deal with several different nonsteroidal, anti-inflammatory drugs to which people were having severe reactions. Upjohn's claim that unwarranted delays plagued the approval of Ansaid is probably strongest with respect to the two-year period from May 1984 to May 1986. However, FDA maintains that during this time it was approving other drugs and taking the time it believed was necessary to ensure the safety of nonsteroidal, anti-inflammatory drugs, including Ansaid.

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