Executive Summary

FDA PLANNING COMMITTEE: BLUE RIBBON PANEL TO PREPARE FOR 1990s is expected to be announced by HHS in an upcoming Federal Register notice, perhaps as early as the week of Dec. 4. The notice is likely to solicit nominations for participation on the commission. The primary charge to the panel will apparently be to map a strategy for the agency's allocation of limited resources. As outgoing Commissioner Young has noted in discussing the generic drug investigation, FDA's responsibilities have been increasing, while the Administration over the past nine years has resisted large increases in the agency's budgetary authority. Establishment of special commissions to review the role and functions of FDA is not a new government tactic. The Dorsen Panel, the Melmon Commission, and the McMahon Commission -- each nicknamed for its chairman -- were convened between the mid-1970's and the middle of this decade to examine agency operations. Those earlier commissions focused primarily on the drug approval process. The Federal Drug Approval Process Commission, chaired by Tulane Pharmacology Professor Gilbert McMahon, PhD, was established at the behest of Congress, particularly Rep. Scheuer (D-N.Y.) and Rep. Gore (D-Tenn.), who was elected to the Senate in 1984. In an effort to speed new drug reviews, the group recommended that FDA rely more on outside experts in designing and reviewing clinical trials and that FDA-sponsor conferences begin earlier in the testing phase. In its 1979 report, the Joint Commission on Prescription Drug Use, chaired by Kenneth Melmon, MD, Stanford, called for greater reliance on postmarketing surveillance. HHS (then HEW) established the Review Panel of New Drug Regulation, chaired by New York University constitutional law professor Norman Dorsen. In 1976-1977 the panel examined FDA's NDA review process and investigated allegations of improper conduct among agency staff -- a possible precedent for the upcoming panel.