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

ORTHO "EFFICACY WITH ACCURACY" ADS INTRODUCE DELCAP RETIN-A dispensing cap but downplay the product's approved use for severe acne vulgaris. The professional ads highlight "significant clinical improvement" and "less than half the irritation." Nowhere on the multi-color pages of the ad is the approved indication mentioned. It is carried in the brief summary prescribing information as required. The indirect cultivation of the anti-wrinkle use for Retin-A is drawing flak for Ortho. The promotions for the product, for example, were the subject of a Feb. 4 segment on the TV magazine show "60 Minutes." The TV report varied from the usual prescription drug expose in making only tenuous allegations of safety problems from the unapproved use of Retin-A. The criticism of promotional practices stemmed from the view that Ortho is consciously looking the other way to enjoy the expanding unapproved uses for the product. The "60 Minutes" segment questioned Ortho's "public relations campaign" promoting Retin-A's use as a wrinkle treatment. The show concluded by noting that Rep. Weiss (D-N.Y.), chairman of the Human Resources & Intergovernmental Affairs Subcommittee, is taking an interest in Ortho's alleged promotion for unapproved uses. The Weiss subcommittee currently is compiling information to determine whether the publicity that the drug has received from articles published in medical journals and presented at press conferences constitutes an exchange of scientific information or promotion of an unapproved drug. As part of the probe, the subcommittee also is addressing the possibility of conflict of interest for Retin-A researchers who are receiving endowments from Ortho. A recent indicator of the commercial success of Retin-A is a patent suit between the university where the compound was discovered and the company. The Univeristy of Pennsylvania announced Jan. 22 that it is suing Retin-A developer Albert Kligman, MD, for an undisclosed amount. The suit filed in Philadelphia federal court contends that Kligman "breached the University's patent policy and conflict of interest policy by patenting and licensing his anti-wrinkle medication to [J&J] on his own" while he was employed by the university.

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

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