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FDA PILOT PROGRAM TO STUDY FEASIBILITY OF "DRUG SUBSTANCE APPLICATIONS"

Executive Summary

FDA PILOT PROGRAM TO STUDY FEASIBILITY OF "DRUG SUBSTANCE APPLICATIONS" as a replacement for drug master files should be undertaken, Generic Pharmaceutical Industry Association outside lawyer Eugene Pfeifer (King & Spalding, Atlanta and Washington) urged in an April 23 petition to the agency. Under the plan suggested by Pfeifer, FDA would set up a pilot program based on six drugs to determine if an independent review and approval of drug substance applications would speed the review of ANDAs and conserve agency resources. According to Pfeifer, drug substance applications could be submitted to the agency in lieu of drug master files. The drug substance applications would be reviewed and approved independently from ANDA applications. Once approved, the drug substance application would stand as a reference for succeeding ANDAs. Pfeifer suggested the pilot program include the following drugs: hydrochlorothiazide and thioridazine (as examples of pre-1962 drugs commonly subject to ANDA review), methyldopa and furosemide (post-1962 and off patent), and piroxicam and atenolol (still under exclusive marketing status). Under current procedures, ANDA applicants reference drug master files that contain drug substance manufacturing and technical specification information provided by drug substance suppliers. FDA reviewers then evaluate the drug master file for each separate ANDA submitted to the agency. FDA also conducts assays of samples for each ANDA, Pfeifer said. Pfeifer maintained that "notwithstanding an initial DMF review that eventuates in an initial ANDA approval, the same DMF may be, and more often than not is, reviewed a second time, a third time and, perhaps, additional times in connection with subsequent evaluations of other ANDAs." He added that under the current system, "agency laboratories have assayed the same manufacturer's drug substance time and time again." The GPIA lawyer, formerly with the FDA general counsel's office, said that "this redundancy serves no legitimate end. To the contrary, it debilitates the evaluation process. By dedicating reviewer time to redoing work previously done (but which somehow remains unrecognized as having been done) precious reviewer time is diverted from DMFs and applications not yet reviewed." The petition requests also that "following completion of the pilot program and a determination that the results of the program so warrant, the program of independent review and approval of drug subtance applications be broadened to encompass most or all drug substances for which ANDAs are filed, or may reasonably be expected to be filed."
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