FDA Premarket Approval

Wyeth-Ayerst Laboratories was granted a patent for Lodine in February 1978. Although originally intended to expire in February 1995, the patent expiration date was extended until February 1997. Wyeth-Ayerst is attempting to have a private bill passed by Congress that would extend the Lodine patent beyond 1997 because the company believes that the length of time needed to obtain premarket approval by the Food and Drug Administration was excessive. Wyeth-Ayerst contends that the 97-month period taken by FDA to grant approval deprived the company of a substantial period of patent protection. This report reviews the events surrounding the approval of Lodine and clarifies the related circumstances.

GAO found that: (1) the drug manufacturer requested an extension of its patent because the Food and Drug Administration (FDA) took 97 months to approve the drug, which was significantly longer than the average review period for NSAID; (2) the FDA approval period for the drug increased because FDA began closer scrutiny of new NSAID applications due to reported adverse reactions to similar drugs, assigned the drug its lowest review priority, and gave a higher priority to reviewing new generic drugs; (3) the drug's application was disorganized and difficult to review and its clinical tests were flawed; (4) Canada raised concerns about the drug's potential carcinogenicity in animals in 1984; and (5) FDA took 2 years to resolve the carcinogen issue before assigning a new medical examiner to the drug, who then reviewed all the previous submissions for the drug before completing his review.