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Executive Summary

SCHERING MAY DISTRIBUTE BETA BLOCKER BOOK ONLY IN RESPONSE TO UNSOLICITED requests, FDA told the firm at a Nov. 8 meeting to discuss promotion of Normodyne (labetalol).The agency told Schering that the book, entitled "Clinical Pharmacology of the B-Adrenoceptor Blocking Drugs," by Frishman, may only "be distributed in an unsolicited manner directly by Schering because of its strong emphasis on labetalol and its inclusion of unapproved uses for this product," according to an FDA memorandum of the meeting. FDA explained that distribution of the book after "genuinely unsolicited" requests "would be regarded as bona fide scientific intercourse." According to the memo, "it was stressed that no Schering employee, neither marketing or sales force, may lawfully promoted the availability of this book. Furthermore, when sent out in this manner, the book may not bear any disclaimers, labeling or other references to Normodyne or Schering." At the meeting, Schering also agreed to modify its promotion of labetalol as the "first" single entity blocker/dilator.The firm accepted a proposal from FDA Advertising and Labeling Div. Director Lloyd Millstein, PhD, that Schering "interchange the word 'first' in the current headline with the claim 'unique.'" In this way, Millstein pointed out, the "term 'first' will be immediately followed by an appropriate explanation." The change will be instituted in Journal ads beginning with January 1985 issues. Glaxo agreed to a similar change for Trandate after a separate meeting with FDA. The agency indicated that such promotion was not accurate because "pindolol, another -- earlier marketed -- beta blocker, exhibited some vasodilating activity," the memorandum stated. FDA, according to the memorandum, "pointed out to Schering that [it] did not object to a claim that labetalol is the first beta blocker with alpha blocking vasodilating activity."

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