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FDA "BLUE RIBBON" COMMISSION SUBCOMMITTEE ON DRUGS AND BIOLOGICS WILL BE HEADED BY DAVID KESSLER; NEXT COMMISSION MEETING TENTATIVELY SET FOR JULY 11-12

Executive Summary

The FDA "blue ribbon" commission's subcommittee on drugs and biologics will be headed by David Kessler, MD, medical director, Albert Einstein College of Medicine. Commission Chairman Charles Edwards, MD, announced the formation of three subcommittees to focus on specific areas at FDA during the commission's first meeting May 17-18. Kessler will head a five-member subcommittee that will also include: former Kennedy staffer Lawrence Horowitz, James D. Wolfensohn, Inc.; Louis Lasagna, MD, Sackler School of Graduate Biomedical Sciences; American Medical Association President Alan Nelson, MD, and Mylan President Milan Puskar. The choice of Kessler to chair the subcommittee on drugs and biologics gives the former aide of Sen. Hatch (R-Utah) a possible eleventh-hour addendum to his resume, which is now before the FDA commissioner search committee ("The Pink Sheet" May 14, T&G-1). The three subcommittees will meet through the fall and are expected to make informal reports to the full commission by December. The full commission is expected to submit a set of final recommendations to HHS by next spring. The subcommittees plan to hold separate hearings where they will hear from interested groups. The other two subcommittees will focus on FDA's regulation of foods and veterinary products, and medical devices, radiological health and biomedical research. The foods subcommittee will be chaired by Sherwin Gardner, VP-science and technology for the Grocery Manufacturers of American and former FDA deputy commissioner. The medical devices group will be chaired by Frank Samuel, former president of the Health Industry Manufacturers Association. HHS Secretary Sullivan opened the first day of the inaugural meeting of the FDA "blue ribbon" panel, formally known as the Advisory Committee on the Food and Drug Administration, by requesting that the committee make broad assessments and recommendations about the future course of FDA. Sullivan emphasized that the Administration does not expect the panel "to come up with specifics to implement [its] recommendations." Sullivan said he wants "broad advice and...recommendations" and not "a detailed, micro-management plan." The secretary warned that "the task faced by this committee is indeed formidable." FDA "has been asked to do more with less," he noted. "Indeed, since 1979, Congress has passed 21 bills giving the agency more tasks -- each of which added to the agency's mandate: time-consuming, demanding, but admittedly vital work to serve and to protect the American consumer." Sullivan stated: "I am asking each member of the committee and the committee as a whole for its judgment about FDA's mission." He added that the agency's current work "reflects changing priorities, and not the priorities of five decades ago when the FDA was given its basic legislative mandate." The panel should consider "how advances in science and technology have altered the character and content of applications submitted to the FDA and how they are transforming the agency's internal operations." One main consideration for the panel is to determine "whether FDA's energies and resources are focused on the right objectives," Sullivan said. Edwards, in his opening statement, advised the committee to "guard against getting bogged down in a minute examination of the operational and programmatic issues that are facing this agency. I do think that would involve the committee in a kind of micro-management that would lead nowhere and would turn us away from what our major task is." He continued: "Our task then is lay a broad foundation for FDA's future." Edwards noted that he has held discussions with a number of people about FDA and that he has "come away from those discussions convinced that the FDA's problems are far deeper than I frankly had originally thought." Before breaking into subcommittees, the full commission plans to meet again on July 11-12. At that meeting, the committee will focus on the "major cross-cutting issues facing FDA -- those that have a bearing on all the agency's programs and responsibilities," according to a statement issued by Edwards. Edwards said the committee will look into "the impact of the ongoing scientific and technological explosion on the development of fundamentally new health-related products and on the agency's need for more sophisticated people, equipment, and strategies to assess these products both before and after they reach the market." The commission discussed inviting outside groups to make presentations on FDA at the July meeting. Richard Merrill, University of Virginia law school research professor and former FDA chief counsel, suggested that the commission invite groups that have a long history of scrutinizing the agency, such as the General Accounting Office or congressional oversight staff. James Grant, chairman and CEO, T-Cell Sciences, and former FDA deputy commissioner, presented a tentative work plan for the July meeting. Noting that outside expections for FDA continue to expand, adding to FDA workload, Grant suggested the commission look at FDA's mission as a starting point. Secondly, he suggested, the commission could look at the agency's scientific and technologic capabilities and assess, for example, the adequacy of its ability to recruit and keep medical and technical talent. Grant also proposed that the commission look at FDA's stature and whether it is declining, as well as the "leadership question" at the agency, other management questions and issues of the agency's "independence" and "integrity." The panel will assess the role and responsibilities of the commissioner job at the agency; HHS has separately instituted a search for a new commissioner. The department reportedly expects that a new commissioner will be selected prior to the completion of the blue ribbon panel's work. Edwards is acting as a consultant in the search. The blue ribbon committee began its deliberations with one less panel member than originally planned. Syntex President and CEO Paul Freiman stepped down from the committee just prior to the panel's first meeting at the request of HHS Secretary Sullivan, who was apparently concerned about fallout from outside criticism of Freiman's affiliation with the Syntex' recall of infant formula over 10 years ago. Sullivan's decision to ask Freiman to step down may have been influenced by a phone call from Sen. Howard Metzenbaum (D-Ohio) on the day before the panel's first meeting. Reportedly, Metzenbaum questioned Sullivan about Freiman's standing on the panel. Sullivan also received a letter last month from a consumer advocacy group, Formula, Inc., which requested that Freiman be removed from the panel because of the way Syntex handled the infant formula recall ("The Pink Sheet" May 14, "In Brief"). Freiman was president of Syntex Labs from 1978 to 1983. Syntex said that Freiman resigned from the committee "because he believes that its work is so important that it should not be distracted by extraneous issues, however ill-founded, which are raised by certain advocacy groups." Committee chairman Edwards said he has encouraged Sullivan to fill Freiman's slot with another representative from industry.
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