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

FDA OTC IBUPROFEN APPROVAL ON ASSURANCE FROM WHITEHALL AND BRISTOL-MYERS FOR HYPERSENSITIVITY WARNING EXCEEDED AGENCY AUTHORITY, McNEIL SAYS IN SUIT

Executive Summary

FDA's approval of OTC ibuprofen on the commitment from Whitehall and Bristol-Myers to include a hypersensitivity warning in consumer promotions goes beyond the agency's regulatory authority, McNeil asserted in a May 24 suit filed in D.C. Federal Court. Noting that "FDA has no authority to supervise, regulate or control the consumer advertising of OTC drugs," McNeil asserted that "FDA's approval of ibuprofen for OTC sale based on the consumer advertising 'conditions' agreed to by AHP and Upjohn is in excess of its statutory jurisdiction and authority, and is therefore unlawful." In support of its contention, McNeil cited the summary basis of approval (SBA) for OTC ibuprofen, in which FDA stated the conditions for approval. According to the SBA, NDA applicants "advised the agency" that their promotional material would include the name of the active ingredient, ibuprofen, in association with the brandname and would warn that aspirin-sensitive individuals should not take the product "at least during the introduction of ibuprofen into the OTC market." In a petition filed with the court on the same day, McNeil asked that it be given access to the background documents concerning the approval of OTC ibuprofen which it said would be the basis of its case that the agency acted improperly with regard to the consumer promotion agreement with the firms. The McNeil petition requests a court order requiring FDA to prouce by May 31 agency correspondence with American Home Products, Upjohn and Bristol-Myers; documents relating to meetings and discussions on ibuprofen consumer advertising; and agency correspondence with its Arthritis Advisory Cmte. since August 1983 and with the Federal Trade Commission. McNeil also wants the three companies' correspondence with FDA and with the ad agencies handling OTC ibuprofen by June 1 (for AHP and B-M) and June 4 (for Upjohn). "We have no desire to delay this litigation so as interfere with the launch of" Advil and Nuprin, McNeil stated. "On the other hand, we believe that the basis on which these drugs have been approved for OTC sale is a clear violation of the FDA's authority." McNeil contended in the complaint that FDA "entered into arrangements with AHP and Upjohn that effectively involve the agency in the supervision and control of ibuprofen consumer advertising, while at the same time creating the appearance that the agency is not asserting any jurisdiction over such advertising." "The sole standards for determining whether a drug may be sold for OTC use" pertain to a drug's labeling, the company argued. "They do not permit consideration of the effect of advertising on the safe and effective use of the drug." In March, McNeil submitted a petition to FDA maintaining that the labeling for OTC ibuprofen should be based on Rx package insert information as a condition of approval ("The Pink Sheet" March 26, T&G-1). The firm also stated that approval of ibuprofen should "not be conditioned upon the agency's control, on either a voluntary or mandatory basis, of consumer advertising for the drug." McNeil concluded in its suit that its sale of Tylenol "will be damaged" by FDA's approval of ibuprofen for OTC sale. In addition, the company said FDA's arrangements with AHP and Upjohn will have "far-reaching, and damaging, consequences for the OTC drug industry" since FDA could impose similar conditions on other marketers of OTC products.

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

OM013164

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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