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

FDA is directing Pharmacia to send a corrective "Dear Doctor" letter to all recipients of a "Medi-Fax" news report on sulfasalazine use from a June meeting of the American College of Rheumatology. FDA believes that Pharmacia sponsored the news report even though the firm's name was not attached to the report. The agency complained to Pharmacia about the news report promotion in a Sept. 27 Notice of Adverse Findings letter. The "Medi-Fax" report touted the unapproved use of Azulfidine (sulfasalazine) and Azulfidine EN-tabs in rheumatoid arthritis. Pharmacia should "draft and submit to FDA a letter to be sent to every person to whom the 'Medi-Fax Report' entitled 'Express Highlights From (the) American College of Rheumatology 53rd Annual Scientific Meeting' [June 12-17] was sent, to correct the false and/or misleading impressions purveyed by this report," FDA says. Pharmacia is discussing the corrective action with FDA. The "Medi-Fax," FDA noted, was described as being the product of "an independent, professional news service, that reports on worldwide medical meetings." However, the agency added, the report "focused, in a purportedly scientific/educational context, exclusively upon an extensive discussion of administration of sulfasalazine for an unapproved use." FDA pointed out that "while this report did not provide for any mention of your firm, we have learned that your firm caused and was possibly involved in its generation and dissemination." Azulfidine is "approved only for use in treatment of mild to moderate ulcerative colitis, as adjunctive therapy in severe ulcerative colitis, and for prolongation of the remission period between acute attacks of ulcerative colitis" and is "not approved for the treatment of rheumatoid arthritis," the letter says. The news report, FDA stated, claims that "sulfasalazine has been demonstrated to be a safe, effective treatment that slows radiographic progression of the disease [arthritis] and is superior to standard treatments." FDA pointed out that although the meeting accepted 850 abstracts and addressed a wide range of issues, the "Medi-Fax" concentrated only on use of Azulfidine for arthritis. This "exclusive focus upon an unapproved use of your product does not constitute 'news,' but rather a deliberate effort to promote this unapproved use on behalf of your firm and in violation of the [Food, Drug & Cosmetic] Act," FDA said. In a July response to an earlier FDA complaint, Pharmacia "admitted to having funded the Medical Education Network's 'coverage' of this event and their dissemination of the 'Medi-Fax' report," FDA said. Pharmacia has assured FDA that it "did not assist in preparing, editing or disseminating the 'Medi-Fax' material." FDA contends that the funding of the report, however, makes Pharmacia responsible for its content. The agency said "by funding Medical Education Network's coverage, your firm 'caused' the publication to be disseminated on behalf of your firm. Therefore, it misbrands your product(s) under the Act." FDA discounted the "editorial independence" claimed by Pharmacia, saying that "does not shield your firm from responsibility." The corrective "Dear Doctor" letter should address three points, FDA said. The letter should acknowledge that the news report "was a paid placement on behalf of your firm, rather than a scientific/educational activity intended to disseminate objective information regarding rheumatoid arthritis and its treatment." Pharmacia should also note that "the usefulness of Azulfidine in the treatment of rheumatoid arthritis is currently under investigation" and that the firm "does not recommend that patients with rheumatoid arthritis be treated with Azulfidine." FDA also requested that the company cease any promotional activities that encourage that the drug be used for unapproved uses. Pharmacia should also provide to FDA detailed descriptions of all public scientific/educational activities for Azulfidine since March 1, 1989. The agency is currently working on a guidance for the agency's regulation of scientific/educational programs and company-sponsored symposia. At a recent Food and Drug Law Institute meeting, Division of Drug Advertising and Labeling Acting Director Ken Feather predicted that the guidance would be released "before the end of the year" ("The Pink Sheet" Oct. 9, p. 6).

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