STATUTORY AUTHORITY FOR FDA ADVISORY COMMITTEES

STATUTORY AUTHORITY FOR FDA ADVISORY COMMITTEES would be one of the several beneficial side effects to be gained if Congress passes FDA "revitalization" legislation, FDA Center for Drug Evaluation & Research Deputy Director Gerald Meyer noted May 4 at a drug development conference in Washington, D.C. Given FDA's efforts to improve and expedite drug reviews -- including expanded use of advisory committees -- statutory authorization for the advisory panels would provide explicit support for such efforts, he maintained. Meyer added that the legislation would also set up a Human Food Safety Technology and Nutrition Advisory Committee. That panel should prove useful as FDA becomes more involved in evaluating health claims in food products, he commented. Creation of a specific food safety panel might prove a useful precedent for the Proprietary Association, which has urged for several years that FDA establish a similar standing OTC drug advisory committee. P-A has argued that a permanent OTC committee is necessary in the post-OTC Review era. The panel would provide input on matters such as monograph amendments and Rx-to-OTC switches, the association suggests. FDA has resisted the idea so far, preferring instead to rely on its existing prescription drug advisory committee system when outside expertise is required on OTC drug issues. Meyer said FDA revitalization legislation, introduced by Sen. Hatch (R-Utah), would address the agency's critical need for additional office space. Even though FDA has benefited in recent years from congressional moves to provide funding for additional staff, particularly in the drug review area, this largesse has been blunted by the agency's inability to house the new people, Meyer declared. "We are getting the [new staff] positions and the dollar resources, but we're behind the eight ball on space." The legislation will also help bridge the widening disparity between top government salaries for medical reviewers and physician salaries in the private sector, Meyer said. Currently, salaries for FDA reviewers range between $ 70,000 and a pay ceiling of $ 90,000, he explained, whereas, "there is a standing offer [for FDA medical officers] at most of our local hospitals, where the starting salary is 140K." The legislation would raise the FDA salary ceiling to $ 110,000 , "which would narrow the gap," he maintained.