PFIZER’s SERTRALINE REVIEW BY FDA ADVISORY COMMITTEE POSTPONED

Executive Summary

PFIZER's SERTRALINE REVIEW BY FDA ADVISORY COMMITTEE POSTPONED because of concerns that possible Gramm-Rudman budget sequestrations will prevent funding of the meeting and furlough agency staffers who would attend. FDA's Psychopharmacologic Drugs Advisory Committee was tentatively scheduled to meet Oct. 1 to discuss Pfizer's NDA for its serotonin re-uptake inhibitor in treating depression. The meeting will not be rescheduled until the federal budget situation becomes clear, the agency said. The possibility of impending budget cuts also has affected the scheduling of several other upcoming advisory committee meetings. The Oct. 11-12 meeting of the Fertility and Maternal Health Drugs Advisory Committee also has been postponed; it is now scheduled to meet on Feb. 7-8. The panel agenda for that meeting includes a discussion of combined hormone replacement therapy for treatment of menopause symptoms/osteoporosis and ways of improving instructions for taking oral contraceptives. In addition, the FDA Blood Products Advisory Committee's Oct. 18-19 and Oct. 29-30 meetings have been placed on hold, the agency said. The meetings still may be held on schedule if a budget package can be negotiated. Those agendas have not yet been set, FDA indicated. Other advisory committee meetings scheduled for late October have yet to be affected. An Oct. 22-23 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee is still on. The agenda includes consideration of three drugs: Aredia for treating hypercalcemia related to bone metastases, Genzyme's Ceredase for Type I Gaucher's Disease, and Bristol-Myers Squibb's cholestorol-lowering agent Pravachol. Similarly, a Gastrointestinal Drugs Advisory Committee meeting, scheduled for Oct. 22-23 to consider SmithKline Beecham's Tagamet for treatment of gastroesophageal reflux, has not been canceled or postponed.