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Executive Summary

SCHERING THEO-DUR ANTI-GENERIC SYMPOSIA CALLED FALSE, MISLEADING, and lacking in fair balance in a Jan. 27 FDA letter of adverse finding. The letter requests that Schering-Plough "immediately cease" company-sponsored promotional seminars conducted by an unnamed California physician to "local pharmacy association meetings." FDA noted that the physician's comments "contain numerous falsehoods as well as a broad range of misrepresentations and innuendoes regarding competing products." FDA also pointed out that members of Schering-Plough's sales force were present at the meetings. The letter is FDA's second complaint regarding Schering's promotion of Theo-Dur versus other controlled release theophylline products. In February 1987, FDA sent a similar letter to Schering objecting to misleading claims for Theo-Dur in a videotape used by the company's sales force. Noting the earlier letter, FDA said it has "even a greater concern when the person speaking at media appearances or seminars delivers a false and/or misleading message on an ongoing basis under the firm's continuing sponsorship with the firm thereby being aware of the nature of the presentation." FDA also asked Schering to cease disseminating a study in Theo-Dur promotional materials conducted by Baker et al. that makes "an open-ended claim" regarding Theo-Dur's superiority to generics even though the study was limited to "B" rated generics. In addition, FDA called the study "seriously flawed" in that it "fails to make known the availability of 'A' rated products." The FDA letter also objects to Schering "Dear Pharmacist" letters that describe Theo-Dur's absorption as "zero order." The letter of adverse finding was mailed to Schering the day after FDA moved Forest's Theochron 100 mg, 200 mg and once daily use of 300 mg to "AB" rated to Theo-Dur. Previously, only Theochron 300 mg had been rated bioequivalent with the Schering/Key product. Schering management met with officials in FDA's drug standards division on Jan. 30 to voice the company's disapproval over the new "AB" ratings for the Forest product.

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