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Executive Summary

An expert panel put together by the Generic Pharmaceutical Industry Association plans to issue a report within six months on the generic drug industry and FDA's approval process for generics, committee Chairman Lewis Engman told a Feb. 8 press conference to announce formation of the committee. The report could contain legislative recommendations "to the extent that we feel that we have some helpful suggestions that need legislative authority to [be] put into effect," Engman said. GPIA formed the independent committee to examine the generic drug industry and the ANDA approval process and to recommend changes to reassure the American public of the safety and efficacy of generic drugs in the wake of reports of submission of false data and the offering of illegal gratuities to FDA employees. Engman said the committee will try to define "the nature of the problem" and determine whether there is "something in the process itself [against] which a safeguard could be introduced to help the process in terms of its integrity." Called the Blue Ribbon Committee on Generic Medicines, the panel represents the generic drug industry's own effort to analyze the factors that allowed and led to the generic drug crisis that has rocked the industry over the last year. The industry committee will focus solely on generic drugs and FDA's regulation of them. Meanwhile, HHS continues to assemble its own "blue ribbon" panel that will examine the entire FDA -- including generic drug review. Announced by Secretary Sullivan last December, the advisory committee will also consider FDA funding issues and help map a strategy for operating the agency in the 1990s. One stumbling block is that HHS has yet to select a chairman for the group ("The Pink Sheet" Feb. 5, T&G-2). The generic industry, by bringing together objective consultants from outside the industry, hopes to add weight to any recommendations it makes to the Bush Administration and to Congress for addressing the recent scandal. On Capitol Hill, the House Energy & Commerce/Oversight Subcommittee's legislative proposals are expected to include amendments to the Food Drug & Cosmetic Act. Committee Chairman Engman is a Washington, D.C. lawyer (Winston & Strawn). He was president of the Pharmaceutical Manufacturers Association from 1979 to 1984, after serving as chairman of the Federal Trade Commission. The other members are University of California at San Francisco Pharmacy Dean and former FDA Commissioner Jere Goyan, PhD; U.S. Pharmacopeia Executive Director William Heller, PhD; University of California at San Francisco Pharmacy Professor Leslie Benet, PhD; American Medical Association Trustee Ray Gifford, Jr., MD, who is also vice chairman of the Cleveland Clinic Foundation's Medicine Division; Johns Hopkins University Associate Professor of Medicine Andrew Whelton, MD; and Washington, D.C. lawyer Lee White (White Fine & Verville), former chairman of the Federal Power Commission. Engman suggested that the generic drug crisis is a threat to the innovator companies as well as to generic firms. The criminal and congressional investigations have uncovered improprieties that threaten "the importance of the process, the integrity of the drug approval process itself at FDA," Engman said. "I think that all members of the industry, whether they be brandname or generic companies, should be concerned equally about the integrity of that process -- in fact, I have no reason to believe that they are not." Committee member Jere Goyan, PhD, pharmacy dean of the University of California at San Francisco, told the press conference that the group will probably consider whether tighter bioequivalence standards are appropriate for generic copies of drugs with narrow therapeutic ranges. "The charge has been made" that generic products are permitted too much deviation in bioavailability from reference products, particularly those with narrow therapeutic ranges, Goyan pointed out. On the other hand, generic manufacturers "point out that the batch-to-batch variation in innovator products is often as big," he said. The issue is among "lots of questions we'll be looking at."

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