March 20, 2003

A New FDA Strategy to Regulate Company Press Releases?

Arnold & Porter Advisory

A new action by FDA may signal a shift in enforcement strategy towards regulation of press releases that the agency may hope will avoid First Amendment concerns raised by other enforcement tools. On March 14, 2003, FDA issued a "Talk Paper" to publicize its objections to a press release disseminated by pharmaceutical manufacturer SuperGen regarding the cancer drug Mitozytrex (mitomycin). See "FDA Warns Public About Misrepresentations in Marketing Claims About Drug to Treat Cancer," available at The Talk Paper admonished SuperGen for a November 15, 2002 press release in which the company allegedly made exaggerated claims of safety and efficacy and failed to include adequate risk information. Calling the statements "misleading," "demonstrably false," and "particularly egregious," FDA stated that it was important to correct the record given the product's intended use for life-threatening conditions. FDA made the Talk Paper available four months after SuperGen's press release, but did not indicate the reason for the delay.

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