FDA ADVISORY COMMITTEE REDUCTIONS COULD INCREASE REVIEW TIMES

FDA ADVISORY COMMITTEE REDUCTIONS COULD INCREASE REVIEW TIMES for drug and biologic applications, the Pharmaceutical Manufacturers Association maintained in an April 12 letter to HHS Assistant Secretary for Health-designate Philip Lee, MD. Commenting on a Feb. 10 executive order from President Clinton calling for each department and agency to terminate not less than one-third of its advisory committees, PMA President Gerald Mossinghoff said that "reduction in the number of advisory committees at FDA would diminish the cost effectiveness of this valuable resource, could impact on the safety of new drugs and biologics, would increase the review time for FDA applications, and ultimately have a negative public health impact in the United States." Mossinghoff urged that when implementing the executive order HHS consider recommendations made in the Institute of Medicine's 1992 report on FDA's advisory committees. Mossinghoff cited the report's conclusion, which states that the advisory committee system is "fundamentally sound, has served the agency well and does not need wholesale reorganization" ("The Pink Sheet" Dec. 14, 1992, p. 20). FDA and HHS are in discussions on how FDA's advisory committee system can be downsized. HHS is working under a May 10 deadline to send recommendations to the Office of Management & Budget. The cuts can be made in committees that are subject to the Federal Advisory Committee Act and not required by statute, according to the executive order. Under the order, the cuts are to be made by the end of fiscal 1993. Each FDA center and office has drawn up a list of options for cuts. The options range from cutting some or all of the committees, combining committees, reducing the number of members and decreasing the frequency of meetings. Another strategy for reducing expenses without cutting the size of committees would have FDA use only government facilities for committee meetings and reduce committee expenses by 5%-15%. Ann Witt, special assistant to Deputy Commissioner for Operations Jane Henney, is coordinating the review for FDA. Witt is also heading up FDA's effort to implement IoM's recommendations for improving FDA's advisory committee process. The agency has set up working groups, which involve members of committee management in each center, to evaluate the recommendations for possible implementation. FDA hopes that the working groups will make their decisions by the end of 1993 or in early 1994.