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FDA BIOEQUIVALENCE TASK FORCE RECOMMENDATION FOR AMENDING ADR REGS TO AID DETECTION, ASSESSMENT OF THERAPEUTIC FAILURES HAS ENDORSEMENT OF GPIA AND PMA

Executive Summary

Both the Generic Pharmaceutical Industry Association and the Pharmaceutical Manufacturers Association have expressed support for a recommendation by FDA's Bioequivalence Task Force to modify the agency's adverse drug reaction reporting requirements so that therapeutic failure can be detected and assessed more readily. In a press statement on the agency's Bioequivalence Task Force Report, GPIA said it "applauds" the recommendation that FDA modify its adverse drug reaction (ADR) reporting regulations to facilitate FDA investigations of adverse drug reactions to identify "signals or clusters of possible important instances of product failures." The association added that it "thoroughly agrees" with the importance of distinguishing between patient failures, which the report calls "a relatively common component of most drug treatment," and product failures. The report recommended that FDA "fully investigate possible inequivalence only when there is good evidence of a problem and not on unsupported anecdotes" ("The Pink Sheet" Feb. 15, p. 11) The task force analyzed information on generic drugs' bioequivalence standards submitted to FDA during and since a three-day public conference in the fall of 1986. GPIA President Dee Fensterer said the FDA report "is of major importance" because as part of its development, "the brandname drug companies were given a full and complete opportunity to present their arguments against generic drugs in a scientific forum, and they came up with nothing." The Task Force had said it "sees no need to recommend major changes in the way FDA approves drug products." PMA said it was "encouraged by several recommendations," citing the suggestion for improving FDA's system of detecting and assessing therapeutic failures. "We look forward to working closely with FDA on these and other changes," the association said. On the other hand, PMA maintained the report leaves other problems "unresolved -- in particular, the validity of bioequivalence testing as an assurance of interchangeability of drug products under all actual conditions of use." GPIA maintained that "many of the suggestions for changes made at the conference were rejected outright by the task force as unnecessary or unworkable." The association added that while "several other proposed changes were referred for further study" in the contingency that "problems necessitating those changes ever appear," the task force said there is currently no evidence of such problems. GPIA "strongly" endorses the task force recommendations to improve dissemination of information about bioequivalence standards and the availability of generic drugs. "These recommendations will help ensure that health professionals receive up-to-date, scientific information about the therapeutic equivalence of generic drugs," Fensterer said. Recommendations "particularly welcomed" by GPID directed doctors and pharmacists to advise patients of the possibility of generic substitution and to discuss with them nontherapeutic differences among brands, particularly tablet or capsule colors, in order to avoid patient confusion. On the other hand, the association expressed "some disappointment" in the report's conclusions regarding "poorly bioavailable" pioneer products. FDA will "continue to encourage" the marketing of "generics with better formulations" than their brandname counterparts, GPIA noted. However, the agency will rate such generics as "bioinequivalent," GPIA said, "even though blood level equivalence is the same when the generics are administered at a lower dosage than the brandname products." The association "would have preferred to see FDA have the better formulated generic product become the reference standard" and encourage reformulation of poorly bioavailable brandname products.

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