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Executive Summary

ANDA SUMMARY BASIS OF APPROVAL DOCUMENTATION SOUGHT BY PMA in proposed language for regulations to implement the Waxman/Hatch Act. The Pharmaceutical Mfrs. Assn. is suggesting to FDA that the agency treat the publicly available information on both ANDAs and full NDAs similarly under new rules to flesh out the Waxman/Hatch Act. "Under current FDA regulations," PMA noted, "at the time of approval of a full NDA, a summary of the basis of approval is made publicly available." The assn. argues that the summary concept "should be applicable to abbreviated and paper NDA approvals also so as to give interested parties the opportunity to review in summary form the results of bioequivalence tests conducted by the applicant and determined to be sufficient to warrant FDA approval." PMA urged FDA to use the same approach employed with NDA applicants to prepare the summaries -- i.e. to have the sponsor submit a draft of a summary basis of approval and let the agency approve or modify that draft. Drafting its own proposed regulatory language, PMA urged that the summary be prepared in one of two ways. The first approach would call for the ANDA sponsor to produce an initial version of the summary. According to PMA's language, "the Division of Generic Drugs [at FDA] may at an appropriate time prior to approval of the application require the applicant to prepare a summary of such data, which will be reviewed and, where appropriate, revised by the Division." Alternatively, FDA could "prepare its own summary of such data," PMA noted. PMA asked FDA to require "a summary of the results of all bioequivalence testing" in the public explanations of ANDA approvals. The assn. elaborated on the type of bioequivalence data that should be incorporated in the summaries: "data to describe the area under the curve, the concentration maximum and the half life with respect to the reference drug." Standards for generic bioequivalence testing were also addressed by PMA. The brandname assn. would require generic versions of an NDAed product to meet at least the same bio test standards for approval as the pioneer product. PMA's proposed language would require that a me-too application show that the generic product has bioavailability "equivalent to that of the referenced product." PMA further suggested that the generic sponsor "shall utilize, at a minimum, the same method and number of bioequivalence and bioavailability tests as were performed on the referenced listed drug, unless the Secretary determines that newer methods of testing are likely to produce information that is more accurate than that which would result from the original method of testing the referenced listed drug." The PMA approach would let the pioneer mfr. determine the type of bio work that follow-up mfrs. must submit. According to an explanation of its proposal, PMA said: "Since different classes of drugs require different types of absorption studies and other bioavailability, reliance on prior FDA determinations of the proper number and type of studies required for a particular drug is the most logical approach."

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