Firms Providing Off-Label Articles Must Stay Mum

Manufacturers providing journal articles on off-label uses of their products under a new draft guidance must not make comments on the articles or grant requests for additional information, an expert advises.

There is a fine line between scientific education and promotion, Alan Minsk, a partner with the law firm Arnall Golden Gregory, said. He cautioned that the loss of credibility with the FDA and the marketplace may potentially attract more attention from the agency in the future.
 
Companies must pay special attention to pictures, icons, symbols, website addresses and other forms of communication. For example, if a product is not indicated for pediatric use but pictures of children are used in advertising, the product may be misbranded.

Industry and consumer advocacy groups have submitted comments to the FDA on the draft. The industry-organized Medical Information Working Group supports the draft’s intent, saying patients benefit from “increased distribution of off-label use information.”

The Patient and Consumer Coalition said the protections offered by the draft are “poorly defined, subjective and difficult to monitor.”

The draft guidance, “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Devices,” is available at www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0053-gdl.pdf.