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AYERST QUESTIONS UNIFORMITY OF FDA GENERIC APPROVAL STANDARDS: PROPORANOLOL GENERIC APPROVAL TESTS DIFFERED SIGNIFICANTLY, COMPANY TELLS CALIF. CMTE.

Executive Summary

The summary bases of approval for the four generic versions of propranolol approved by FDA are "totally different," Ayerst VP-Medical Affairs David Shand, PhD, maintained in a presentation to the California Bioequivalence Advisory Panel Nov. 4 in Los Angeles. With the differences in study design and powers used, "its hard to believe they are for the same drug," Shand declared. He suggested that the panel consider the lack of uniform standards in FDA's approvals of generic propranolol. "In its approving of four generic propranolols, the FDA used very different standards of review," Shand asserted. For example, he said, two generic mfrs. "did only single dose studies," while two "studied steady state." Shand also questioned the presence of metabolites in the generics. He said that in one of the generic approvals, "they were allowed to use total propranolol," which is the active ingredient plus propranolol glucuronide, an active metabolite. In addition, he pointed out that one generic contains a color additive which is a potential allergen, and asserted that the ingredient represents an "unnecessary risk." Bioequivalence Advisory Panel Chairman Leslie Benet, PhD, commented: "I would like to see justified the inclusion of glucuronide plus the total drug." He added he would "ask FDA" if it has such information. He also indicated a desire to see "more data on single dose studies vs. multiple dose" with generic propranolol. The independent three-member panel of bioequivalence experts was established by the California Dept. of Health Services as part of the settlement of litigation between Pharmacists Planning Services and the state. The panel makes recommendations to the California Medical Therapeutics and Drugs Advisory Cmte. on drugs being considered for inclusion in the California Maimum Allowable Ingredient Cost (MAIC) program. Lederle Maintains FDA Is "The Only Place" For Establishing Generic Drug Standards Calling the California panel an inappropriate forum for making judgments on the contents of ANDA data, a representative from Lederle said his company would not be submitting information to the panel on its generic propranolol or any other Lederle generic product. He asserted that the panel's procedures are slanted in favor of brandname mfrs. "The only place where we can develop those standards," he said, "is with the FDA; we do not know the standards that the innovator will come and bring to you." Chairman Benet reiterated that the panel's "prejudice is to go along with ]FDA's[ AB ]therapeutic equivalence[ rating unless we hear scientific evidence to the contrary." Ayerst was the only company to make a presentation at the meeting, which was called to consider seven drugs. For three drugs (nitrofurantoin, thioridazine, ibuprofen), no new evidence was submitted; and the panel made no changes in its previous recommendations concerning those classes. At its third meeting in March, the panel recommended against including the thioridazine class on the MAIC list because of the lack of standards in the bioequivalence testing for the class. An Upjohn spokesman indicated that his company may submit data in the future relating to some of the newly approved generic versions of ibuprofen. He noted that work is underway "with a number of these products now, comparing them with our ibuprofen brand Motrin." The Upjohn spokesman added: "We haven't had ample time to study all these yet."
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