Executive Summary

Center for Drugs and Biologics is recommending that Commissioner Young deny Upjohn's Aug. 4 request to reopen the record in the Depo-Provera hearing for additional evidence and to allow oral argument. In a letter to the commissioner, the center asserts that Upjohn's petition should be denied because the firm "has set forth no facts that establish the importance, and . . . even the relevance of the submissions that it proposes to be considered." Upjohn is requesting that the record be reopened to receive data from an interim report on a World Health Organization study of Depo-Provera, a new historical study on the association between Depo-Provera and breast cancer, a post-marketing surveillance study of Depo-Provera in the U.K., and a report by the Expert Committee on Reproductive Physiology.