FDA Premarket Approval

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.

GAO found that the manufacturer requested a 53-month extension of the drug's patent term, based on its allegations that FDA: (1) took 79 months to grant premarket approval, 53 months longer than its average period for similar drugs; (2) needlessly requested different data displays and formats that had no scientific basis; (3) had limited contact with the company for the first 4 years after it submitted the new drug application; (4) lost some of the files regarding the drug; (5) unnecessarily attempted to reconcile its drug with a similar drug; and (6) focused its resources on responding to congressional and public concerns about the safety of similar drugs. GAO also found that: (1) the manufacturer took about 8 years, almost half of the drug's patent term, to prepare and submit its new drug application in March 1982; (2) other companies took about 7 years to submit their applications for similar drugs; (3) FDA characterized the application as problematic, and issued a 13-page deficiency list within 9 months; (4) the manufacturer submitted a revised application in May 1983, although it believed that all the necessary data were in its original application; (5) between May 1983 and May 1984, FDA concentrated on the company's application for an over-the-counter drug, citing its staffing constraints; and (6) due to reports of adverse responses to similar drugs, FDA concentrated on safety issues regarding the anti-inflammatory drug, but there was no evidence that it unnecessarily requested data, improperly delayed the approval process, or inappropriately compared the drug data with other data before issuing premarket approval in October 1988.