FDA’s off-label guidance may be up for review

The Obama administration will review and may change an FDA guidance on off-label marketing that was approved in the waning days of the Bush administration, according to McClatchy Newspapers. The news group quoted Sen. Chuck Grassley (R-IA), a frequent FDA critic, as saying that a “legislative fix may be in order.” Grassley had said he had serious concerns about a guidance that would deem as appropriate something that “FDA once considered evidence of unlawful marketing.”

The new policy was disclosed in a Jan. 12 final guidance for industry that skipped the customary “draft” document stage for the gathering of comments. The document was issued not by the FDA’s drug or medical device centers which would normally handle such matters, but by the politicized Office of the Commissioner.

Previous agency policy had for many years disfavored dissemination of unapproved use info by drug companies, but the agency was forced by congressional and court intervention to tolerate it under provisions that expired in 2006.