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CHLORPROMAZINE ANTI-GENERIC REPORT REFUTED BY FDA

Executive Summary

CHLORPROMAZINE ANTI-GENERIC REPORT REFUTED BY FDA at a meeting of the Natl. Assn. of Pharmaceutical Mfrs. (NAPM) in Washington, D.C. on June 18. FDA Office of Drug Standards Deputy Director James Morrison presented the agency's preliminary analysis of a report made by a physician at a meeting of the American Psychiatric Assn. in Dallas in May 1985. The report, by Richard Borison, MD, Veterans Administration Hospital, Augusta, Ga., concluded that generic chlorpromazine was not as effective as SmithKline's brandname product Thorazine. Morrison asserted that "it is shameful that serious allegations about performance of generic drugs have been made and widely repeated based on such faulty data." Morrison noted that the Borison report was the subject of an article appearing in the Medical Tribune in September 1985. The report was also cited by Pharmaceutical Mfrs. Assn. VP-Technology John Jennings at a recent meeting of the Food & Drug Law Institute. Morrison said he was unaware of publication of the report in the medical literature. According to Borison's report, Morrison said, 11 patients who were receiving chlorpromizine at the VA Hospital "required an average increase of 475 mg in their daily prescribed dose of chlorpromazine" over the course of a month of treatment, "allegedly to compensate for the lack of effectiveness of the generic product." Morrison said that following the one month period, SmithKline's Thorazine was substituted for the generic, resulting in "a reduction in the daily dose of chlorpromazine." Morrison explained that "the documentation of these allegations consisted principally of a table in [Borison's report] where the mg per day dosing of chlorpromazine was compared for each of the 11 patients for the months of May and June 1984. It was implied that the generic was introduced in June and that the May figures represented baseline data with the brandname product." He noted that on July 14, 1984, the brandname product was reintroduced. Describing the agency's analysis of Borison's report, Morrison stated: "Of the 10 patients for whom we could get records, it appears that half of them were not prescribed chlorpromazine at all in May, either because they had not been admitted to the hospital, or because they were on another drug. To further complicate the picture, the generic drug on which they supposedly had poor performance had been used in the ward since January 1984 with no explanation as to why the patients were . . . out of control in June." Morrison described the Borison presentation as an example of an anti-generic campaign. He commented that the first wave of such campaigns has passed, although they have not completely disappeared. He said that in some respects a "more insidious campaign" is being waged that "involves the use of detail people and speeches by physicians, funded by one or more brandname companies, traveling around the country." Morrison also pointed out that the generic products involved in the Borison comparison were made by brandname PMA mfrs.
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