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FDA AD DIVISION EXAMINING SEARLE CALAN SR PROMOTIONAL CLAIMS

Executive Summary

FDA AD DIVISION EXAMINING SEARLE CALAN SR PROMOTIONAL CLAIMS in response to complaints by Ivax subsidiary Baker Norton Pharmaceuticals. FDA said that the Division of Drug Marketing, Advertising and Communications is "looking into" Baker Norton's allegations that Searle promotional personnel have been telling large pharmaceutical buyers and state formulary committees that Baker Norton's generic sustained-release verapamil is not bioequivalent to Calan SR. In a Dec. 18 letter to Center for Drug Evaluation and Research Director Carl Peck, Ivax counsel Thomas Scarlett of the D.C. firm Hyman, Phelps & McNamara said Ivax had filed "several complaints" with FDA's ad division regarding Searle's alleged "disparagement campaign" against the Baker Norton product. Ivax' letter charges that Searle "is engaged in a negative promotional campaign involving contacts by Searle representatives with major pharmacy buyers to deter purchase of the Baker Norton product." In addition, the letter says, Searle's efforts against Baker Norton's verapamil include "appearances before state formulary committees" to discourage inclusion of the generic. The letter to Peck states that in its contacts with pharmacy buyers and state formulary committees, "Searle's strategy seems to rely on one-sided presentations of data supposedly revealing an alarming potential for adverse health consequences from the Baker Norton product." FDA said that it is "comfortable" with the generic verapamil's safety profile and that the agency is not actively reviewing the merit of the Baker Norton product's AB (therapeutically equivalent) rating. FDA's July 31 approval of Baker Norton's sustained-release verapamil was followed by the Aug. 5 filing by Searle of a citizen petition protesting the approval ("The Pink Sheet" Aug. 10, 1992, p. 6). The company also wrote the New Jersey Department of Public Health, explaining that Calan SR is a racemic mixture of two stereoisomers and that "concentrations of the 'active molecules' (enantiomers) of verapamil need to be measured to determine bioequivalency of modified-release verapamil formulations." In addition, Searle contended that the Ivax product was approved based on data comparing it to Knoll's Isoptin SR, not to Calan SR. In October 1992 the New Jersey Department of Public Health's formulary council voted to allow Baker Norton's generic sustained- release verapamil on the state formulary. The department said it reviewed "in detail" arguments from both Searle and Baker Norton over the course of two meetings, but voted to support the drug's inclusion in the formulary. Illinois has also allowed the generic product on its state formulary. A decision is still pending in Virginia.
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