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Executive Summary

FDA DENIES PHYSICIANS' GROUP PETITION TO HOLD BIOEQUIVALENCE HEARING on narrow therapeutic range generics, to review all ANDAs, and to implement a moratorium on approval of all generic drugs for at least one year while the reviews are under way. In a July 23 letter, FDA Associate Commissioner for Regulatory Affairs Ronald Chesemore denied an Aug. 23, 1989 citizen's petition filed by the Washington, D.C. law firm Sonnenreich & Roccograndi on behalf of a group of 17 West Coast physicians and health professionals ("The Pink Sheet" Aug. 28, 1989, p. 5). Chesemore said that the agency is denying the petition because "FDA has concluded that the intent of your petition is being achieved by the agency's actions under its own ongoing generic drug review -- a review that addresses all of the categories of misdeeds and other problems described in your petition." The petition requested FDA to sponsor "an open hearing on bioequivalence, therapeutic equivalence, and overall safety of and efficacy of generic drugs." Such a hearing was held by FDA in 1985 in the aftermath of Waxman/Hatch. The group wanted the additional hearing to address current issues of safety and efficacy of generic drugs, and suggested a focus on generics used in treating depression, asthma, heart disease, epilepsy, diabetes mellitus, and psychoses. The petition also asked that FDA undertake a review of all ANDAs, including all supplements and amendments approved since enactment of Waxman/Hatch. The agency's actions listed by Chesemore as addressing the physicians' concerns include: the re-review of ANDAs involved with the offering/acceptance of illegal gratuities, the forcause inspections of generic firms and inspections of 20 additional manufacturers, and the sampling of the 30 most-prescribed generic drugs. FDA is also conducting an ongoing quality analysis of over 20 narrow therapeutic range drugs, and has established a Task Group on the Bioequivalence of Anticonvulsant Drug Products. Chesemore added that FDA has established a Generic Drugs Advisory Committee that will provide a forum for discussing scientific and technical issues concerning generics and has created "a quality control group" within the Office of Generic Drugs. FDA is denying the request for a one-year moratorium on all ANDA approvals "because your petition fails to support your contention that 'information submitted in [all] ANDAs must necessarily be insufficient to show that generics are bioequivalent or have the same therapeutic effect as the listed drugs.'" Chesemore noted that the group bases its assertion on the fact that some ANDAs were found to contain fraudulent data and on its claim that some researchers believe that the methodology for determining bioequivalence is "lacking in credibility."



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