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Executive Summary

SCHERING WILL REVIEW MEDICAL SYMPOSIA SPEAKERS PROGRAM to prevent the dissemination of misleading information concerning the firm's theophylline product, Theo-Dur, the firm told FDA in a March 7 letter responding to a notice of adverse findings. "We intend to review our speakers program giving consideration to the objections raised in your letter," Schering stated. "Please be assured, that if there are experts that violate Schering's standards in this exchange of scientific information by presenting falsehoods and/or misleading information, Schering, as a responsible company, will take appropriate action," the company said. FDA issued the notice of adverse findings regarding the company's promotional campaign for Theo-Dur on Jan. 27. The notice objected to "false and misleading statements" about Theo-Dur made at symposia sponsored by Schering ("The Pink Sheet" Feb. 6, T&G-11). Schering met with FDA Feb. 8 to discuss the letter of adverse findings. According to an FDA memo of the meeting, the company management assured the agency that "they are revising the policies of their speakers bureau in an effort to prevent such episodes in the future." The Schering representatives maintained that "they were unaware of the type of comments being made by the physician speaking on their behalf at numerous local pharmacy association meetings," the memo notes. "When excerpts of those comments were read from the transcript, they described the comments as not representative of the views of the firm (although similar comments were contained in a video tape employed by the firm's sales force in 1987)," the memo adds. According to FDA's letter of adverse findings, the physician made various comments that contained "numerous falsehoods as well as a broad range of misrepresentations and innuendoes regarding competing products." Some of those statements include: "In approving long-acting theophylline preparations as bioequivalent, FDA 'requires only that the active ingredient be the same'"; and "Treatment failures have been documented that were directly attributable to substitution from Theo-Dur to other AB-rated theophylline products." FDA's Division of Drug Advertising and Labeling mentioned in the memo of the Feb. 8 meeting that it will disseminate a guideline regarding the division's policies on educational seminars. The guideline should be available in about three weeks, according to the division. In the notice of adverse findings, FDA also asked Schering to cease dissemination of promotional material based on a study conducted by Baker et al. The study, according to FDA, was limited to "B" rated generics and yet makes open-ended claims regarding Theo-Dur's superiority to generics. FDA said that the study was "seriously flawed" in that it "fails to recognize the availability of 'A' rated products." Responding, Schering said that it will only use the Baker study accompanied by a prominent statement similar to one suggested by the agency during the February meeting. FDA recommended that the firm use a statement such as: "This study did not provide for administration of any of the available controlled release theophylline products that are AB-rated to Theo-Dur." Currently, Forest's Theochron 100, 200, and 300 mg products are the only "AB" rated theophyllines. FDA also objected to Schering's "Dear Pharmacist" letters that state: "Of all sustained release oral theophyllines, only Theo-Dur (theophylline anhydrous) Sustained Action Tablets provides zero-order absorption." In its response to FDA, Schering noted that the letters also contained a clarifying statement that Theo-Dur "releases an essentially constant amount of drug each hour." However, the firm stated, "in conformance with your objections . . . we will restrict the qualifying with your objections . . . we will restrict the qualifying statements we use to 'approaches' or 'apparent.'"

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