House questions FDA?s off-label promotion guidance
Rep. Henry Waxman, D-Calif., last year asked the agency not to release the guidance until it provided further information to the House Oversight and Government Reform Committee.
Waxman expressed concerns about the draft guidance in a Jan. 22 letter to FDA Commissioner Andrew von Eschenbach, saying the guidance “would shelter drug companies from responsibility for dissemination of articles on unapproved uses to a far greater extent than at any other time in FDA's history and would undermine the law requiring companies to seek approval before marketing a drug or device.”
In a response to Waxman’s first request in November 2007, von Eschenbach provided a memorandum describing an April 2007 meeting between senior FDA officials and several industry representatives. The representatives urged the FDA to issue guidance allowing the distribution of journal articles discussing off-label uses to protect companies from “federal prosecutors pursuing distributors of this information for criminal conduct,” Waxman said.
The memorandum raises questions about the origins and motivations of the FDA’s draft proposal, Waxman said. The representatives’ motivations for the proposal were to protect companies from prosecution for promoting unapproved uses, not to advance the public health, he added.