FDA Premarket Approval:

Process of Approving Ansaid as a Drug

HRD-92-85: Published: Apr 7, 1992. Publicly Released: Apr 7, 1992.

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Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) process for granting premarket approval for a nonsteroidal, anti-inflammatory drug primarily sold to treat arthritis symptoms, focusing on: (1) whether the manufacturing company delayed preparing and submitting its new drug application; and (2) the company's allegations that the FDA approval process period was excessive.

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.