Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

SCHERING MAY DISTRIBUTE BETA BLOCKER BOOK ONLY IN RESPONSE TO UNSOLICITED

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."

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

ID1132115

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel