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Executive Summary

The Pharmaceutical Manufacturers Association is attempting to remove five product classes from consideration for ANDAs. In a May 24 petition to FDA, the association requests that FDA "establish and implement a formal policy that no abbreviated new drug applications (ANDAs) may be granted for nonsystemically effective drug products." The drug categories that would be affected by the requested action are (1) local anesthetics; (2) topical agents such as topical steroids, topical antifungals, vaginal agents, nasal agents and topical retinoids; (3) gastrointestinal agents that act locally, such as antihypercholesterolemics, anthelmintics, bulk laxatives, antidiarrheals, pancreatic enzymes and antibacterial/antiseptics; (4) inhalant; and (5) ophthalmics. PMA notes that parenteral products would not be affected by the petition. The association also asks that the agency "review and evaluate previously approved nonsystemically effective drug product ANDAs and take all remedial measures necessary to ensure consistent enforcement of that policy." FDA "must establish scientifically valid clinical standards for abbreviated applications for approval of generic versions of nonsystemically absorbed drug products," PMA asserted. "Such standards do not currently exist and are not provided for under existing law. Until such standards are created and the law is changed to accommodate them, ANDAs for those products cannot and should not be approved." The agency, the association continued, "has no legal basis for approving ANDAs for nonsytemically effective drug products since sponsors cannot provide the statutorily mandated bioequivalence data." Noting that the agency has approved ANDAs for nonsystemically absorbed drug products by relying on alternatives to clinical tests to establish bioequivalence, PMA contends that "such testing cannot provide the legal basis for ANDA approval." The argument that "bioequivalence data" must be submitted to support an ANDA under the law has been a cause celebre of Schering. That company, which has major stakes in at least three of the classes, first raised the issue in a Dec. 4 petition to the agency ("The Pink Sheet" Dec. 11, T&G-12). PMA listed examples of agency announcements or publications on various classes of nonsystemically effective drug products as "strongly" supportive of its position. For example, the petition notes that an FDA draft guidance document issued in February following an agency workshop on bioequivalence of topical antifungal drug products "indicates that only clinical trials will produce a sufficient basis upon which to determine whether ANDA approval is appropriate." Of the eight categories of information necessary for an ANDA under the 1984 Drug Price Competition and Patent Term Restoration Act, the association said, "none of those categories encompasses information that would be generated by the types of alternative studies possibly permitted by FDA under the 1977 regulations to demonstrate bioavailability or bioequivalence." In addition, the association pointed out, the recently enacted Generic Animal Drug & Patent Term Restoration Act specifically authorizes "an alternative bioequivalence standard for use in abbreviated applications for animal drugs where measurement of the rate and extent of absorption or excretion is an inappropriate or impractical measure of equivalence." Noting that "no comparably broad provision exists for human drugs," the association contends that "one can only conclude that the Congress did not intend for the ANDA process to be available to manufacturers of nonsystemically effective human drug products." In conjunction with its request that the agency deny all ANDAs for nonsystemically absorbed products, PMA also asked FDA to "refuse to disclose the safety and effectiveness data for any drug product that is the subject of an approved NDA where FDA cannot approve an ANDA because bioequivalence cannot be established." The 1984 Waxman/Hatch law permits public disclosure of the safety and effectiveness data in approved NDAs upon the date that an ANDA for the drug product could be approved. However, PMA says, since "FDA is without authority to approve ANDAs for nonsystemically effective drug products," the provision "relating to the release" of data "in the ANDA context, cannot constitute the basis for disclosure of information contained in NDAs for that category of drugs."

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