FDA turnabout sows off-label confusion

WASHINGTON - A recent appeals court ruling has lawyers scratching their heads over FDA's legal authority to limit the ability of drug sponsors to disseminate peer-reviewed literature about unapproved uses of approved products, as well as their sponsorship of Continuing Medical Education (CME) programs for doctors that focus on off-label uses.

Last month's ruling by the U.S. Court of Appeals for the District of Columbia Circuit "is clear as mud," according to Alan Bennett, an attorney at Bennett, Turner & Coleman in Washington, and a former attorney at FDA. Indeed, both the Washington Legal Foundation (WLF), which had sued to restrict the agency's off-label powers, and government officials are claiming victory...