Allergan challenges FDA's off-label regulations

Allergan Inc. (NYSE:AGN) filed suit against FDA in the U.S. District Court for the District of Columbia challenging regulations that prohibit the dissemination of information about off-label use of an approved drug. In its complaint, the company said FDA's expansive definition of "labeling" impairs a manufacturer's ability to communicate truthful information to healthcare professionals to reduce the risk of adverse events from lawful off-label drug use.

Allergan is seeking declaratory judgment that the regulations violate the First Amendment and are inconsistent with the Federal Food, Drug & Cosmetic Act. The pharma also is seeking a preliminary injunction against the agency to prevent enforcement of the regulations. ...