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



Executive Summary

OTC ADVISORY CMTE. EARLY 1994 MEETINGS WILL FOCUS ON SWITCHES, FDA Nonprescription Drugs Advisory Committee Chairman Randy Juhl, PhD, told the Food & Drug Law Institute's Annual Educational Conference Dec. 15. Juhl, who is from the University of Pittsburgh, predicted that "during the next six months, all of our meetings will be taken up by switch applications" for precription drugs seeking OTC marketing status. FDA tentatively has set the first 1994 meeting of the advisory committee for Feb. 16-18. The first day of the meeting is slated to be a joint session with FDA's Dermatologic Drugs Advisory Committee, the second day will be a joint meeting with FDA's Antiviral Drugs Advisory Committee and the final day will be held in concert with FDA's Gastrointestinal Drugs Advisory Committee. A pending Rx-to-OTC switch application in the antiviral area is Burroughs Wellcome's NDA for OTC Zovirax (acyclovir) as an orally administered treatment for recurrent genital herpes. In the gastrointestinal arena, NDAs pending at FDA include Rx-to-OTC switches for J&J/Merck's H[2] antagonist Pepcid (famotidine) and SmithKline Beecham's Tagamet (cimetidine). An Rx-to-OTC switch application for Tagamet was the subject of a Sept. 9 joint meeting of FDA's Nonprescription and Gastrointestinal Drugs Advisory Committees, which determined that clinical trials for OTC cimetidine did not demonstrate the drug's efficacy in relieving heartburn symptoms ("The Pink Sheet" Sept. 13, p. 11). SB has indicated that it is working with FDA to determine the best way to prove low-dose cimetidine's effectiveness for treating heartburn. Other tentative meeting dates over the next year for the advisory committee are May 18-19, with the second day being another joint meeting with the Antiviral Drugs Advisory Committee; July 28-29; and Sept. 22-23. During his presentation, Juhl attempted to dispel industry notions that "the committee is anti-switch" because it recommended against approval of "the first two switch applications that came before the committee" -- cimetidine and Syntex/P&G's naproxen sodium. "The committee is enthusiastic about the process of bringing meaningful drug products into the OTC market and promoting self care as a way of increasing the status of the health of the population in general," Juhl insisted. Juhl also offered suggestions"for true innovation in the OTC arena," such as over-the-counter migraine treatments and oral contraceptives. Other potential OTCs that "need to be examined," the advisory committee chairman said, are products for "male pattern baldness, stage fright, exercise-induced musculoskeletal pain, uncomplicated hypertension,...strep throat, childhood immunizations, smoking cessation, nicotine maintenance, recurrent genital herpes" and cholesterol-lowering drugs. Juhl emphasized that, while he was not necessarily "suggesting that these are appropriate" candidates for OTC marketing, they are categories "that need to be reviewed and studied" for OTC use. These products would be "better ways for innovation to take place than with a number of 'me-too' drugs coming down the line," he asserted. "In the OTC world," Juhl added, "repackaging the same drug in a new box with a new name supported by millions of dollars of advertising has passed for innovation."

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




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