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FDA PREEMPTION OF OTC LABELING IS ONE RECOMMENDATION THAT SUBCOMMITTEE ON DRUGS & BIOLOGICS MAY INCLUDE IN ITS REPORT TO FULL EDWARDS COMMITTEE

Executive Summary

FDA's preeminence in OTC labeling regulation is supported by the Drugs & Biologics Subcommittee of the Edwards Committee on the future of FDA. At its second meeting, held Nov. 8-9 in La Jolla, California, the subcommittee expressed a consensus in favor of FDA's ability to preempt state labeling regulations for OTC drugs. In response to a question on FDA preemption powers, panel member Joseph Williams (chairman of Warner-Lambert) said: "I would recommend it strongly...It will help in the cost of products to the patient, the user." Edwards Committee Vice Chairman James Grant (chairman of T Cell Sciences) seconded Williams' recommendation. Grant said he would "hang" the issue "on good consumer protection." He explained: "You can't have one OTC product where a consumer in Washington is reading a different thing on the label than a person in Texas." The subcommittee heard from Raymond Wilson, a food and drug scientist at the California Department of Health Services, and a member of the Association of Food and Drug Officials, who testified against federal preemption. "There are times when we have found the [FDA] has not acted as promptly or [the way it should] and therefore the state should have the right to not have preemption of labeling," Wilson maintained. The recommendation to provide for federal preemption of OTC labeling control is one of about 25 recommendations made by various members of the subcommittee (see chart, p. 6). The panel also suggested that FDA regulations should preempt state regs covering blood bank procedures. Jerry Kolins, MD, medical director of the Community Blood Bank of North County, Escondido, Calif., and a representative of the American Association of Blood Banks, urged the subcommittee "to recommend that FDA exercise its authority of preemption." Kolins said the association believes that FDA should be given preemptive powers in order "to maintain an adequate blood supply that is as safe as possible." He noted that state efforts to protect blood safety in response to the AIDS epidemic have often "interfered with our efforts to maintain a safe and adequate blood supply." Subcommittee member Alan Nelson, MD, former president of the American Medical Association, said: "If the FDA is going to do its job right, it has to have the authority to do it throughout the nation. You can't have 50 different jurisdictions flying off on their own." Subcommittee Chairman Lawrence Horowitz, MD, an investment banker with James D. Wolfensohn, Inc., added: "I think most of us agree with that. We also recognize the reality that there would be strong opposition from those states that...don't want to accept what they would view as the lowest common denominator." Horowitz pointed out that the subcommittee's discussion of recommendations is "not necessarily an indication that this is what the report will end up emphasizing [or] not emphasizing." The subcommittee plans to have the report ready before the Dec. 17 and 18 meeting of the full committee. The committee also discussed the idea of an expanded role in the approval process for FDA advisory committees. Summarizing the arguments of several proponents of the idea, Horowitz observed: "I think the gist of what I was hearing was that you want to try to get those advisory committees to be groups that can break logjams, not contribute to them." However, Horowitz suggested that advisory committee members may have a problem with this idea given "the balance between the time that would be required as the [committees'] responsibilities increase, and the compatibility of those responsibilities with their very busy lives, and their own research projects versus the job that needs to be done." The subcommittee rejected outright a recommendation by the Lasagna Committee that a permanent advisory panel be established to monitor the needs and performance of FDA ("The Pink Sheet" Aug. 20, p. 3). Williams summed up the subcommittee members feelings on the recommendation, noting: "More bureaucracy is not needed." Several subcommittee members were in favor of increasing the regulatory perogative of the FDA commissioner. "I think in the promulgation of regulations [we should] go back to where the FDA was in the late 1970's and [give] the commissioner...the authority to issue the regs as opposed to the bureaucratic process that's in now," Williams suggested. The new FDA commissioner, David Kessler, MD, and former chairman of the subcommittee attended the second day of the two-day meeting. He flew to California after being officially sworn in on Nov. 8. Horowitz acknowledged Kessler's presence during the meeting: "I think we're all delighted [with who] the new commissioner is." Kessler will stay involved with the subcommittee's work as a non-voting member. RECOMMENDATIONS BY MEMBERS OF EDWARD's SUBCOMMITTEE Prepared by "The Pink Sheet" from coverage of the Nov. 8-9 subcommittee meeting. Members names in italics. Endow FDA Commissioner with authority to promulgate regulations (Williams). Deregulate noncommercial INDs (Nelson). Establish consistent approval procedures for NDAs and PLAs (Grant). Use flexible range of approval options such as conditional approval along with a Phase IV requirement (Horowitz/Williams). Encourage companies to seek indications in special population groups such as children and the elderly (Nelson). Establish monograph system (Puskar). Establish Office of OTC Drugs (Williams). Establish FDA preemption in area of OTC labeling. Establish FDA preemption in area of blood bank procedures. Develop effective, prospective compliance system (Horowitz). Redefine FDA mission to include protecting consumers from ravages of deadly diseases (Horowitz). Improve computerized information systems (Williams).
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