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FDA INTERNAL COMMITTEE WILL MONITOR EUROPEAN COMMUNITY "HARMONIZATION" PROGRESS; NIGHTINGALE's OFFICE NOW INCLUDES STATE DEPT. LIAISON FOR EEC ACTIVITIES

Executive Summary

FDA is establishing an internal committee comprised of representatives from each of the centers and from the Office of Regulatory Affairs to review European Economic Community (EEC) "harmonization" activities that affect FDA-regulated products. At a top-level briefing attended by FDA Commissioner Young and FDA center heads on Nov. 23, participants discussed how the agency can effectively monitor and review EEC regulatory developments. The meeting, called by Associate Commissioner of Health Affairs Stuart Nightingale, MD, to update the commissioner on the EEC's plan to eliminate internal trade barriers by Jan. 1, 1993, was prompted by a recent trip to Brussels by John Villforth, director of the Center for Devices and Radiological Health. The device center has been particularly active in monitoring the EEC's review of medical device regs. For example, the center helped plan the agenda of a Regulatory Affairs Professionals Society meeting on EEC activities in Amsterdam last June. Nightingale, who is coordinating FDA's review of EEC activities, recently met with EEC representatives in their Washington office. In addition, FDA recently brought on board William Bartley, on loan from the State Department where he was a health attache at the U.S. mission in Geneva for eight years after a term with the Department of Energy. Bartley has been placed in the Office of Health Affairs to assist in the EEC harmonization monitoring effort at FDA. One of his roles is to serve as the FDA representative to an interagency task force that prepares materials for the Advisory Committee on Trade Negotiation, an industry group that meets periodically with the U.S. Trade Representative (USTR). Under Nightingales's supervision, FDA will continue to review pertinent regulatory directives issued by the 12-member EEC. The Department of Commerce has estimated that 30 directives relate to FDA activities, including six that pertain to pharmaceutical issues. FDA is attempting to enter the harmonization dialogue by passing comments on EEC directives through the U.S. International Trade Commission and the USTR's office. The ITC and the USTR office have been designated to process EEC-related communications from U.S. federal agencies and industry. The EEC directives fall into two groups - those already ratified by EEC member states and those subject to further modification. FDA's means for input on the EEC harmonization program are limited; there is no formal EEC provision for third-party input on the directives. Among the concerns at FDA is whether, after removing internal trade barriers, EEC will erect external barriers to free trade. In a larger, more self-reliant European market, economic concerns could come to overshadow safety and effectiveness factors. A second issue concerning FDA is whether EEC will "harmonize" with FDA on the criteria used in evaluating safety and efficacy of products. In the regulation of medical devices, for example, EEC considers a product to be in compliance as long as it meets the essential safety requirements outlined by the medical device directives. At this stage, there is no effectiveness component in the product review process. In addition, FDA currently accepts laboratory data from foreign companies conforming to memoranda of understanding that uphold FDA laboratory standards. FDA is concerned whether these and other quality control agreements will still be valid after 1992. In a related Oct. 31 FDA meeting, Merck Senior-VP Charles Leighton, MD, discussed possible regulatory alternatives that could appear in the EEC drug registration draft directive expected to be issued in late 1989 or early 1990. These include an FDA-like centralized regulatory agency, mutual recognition among the 12-nation regulatory network, or a compromise of both possiblilities.
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