FOUNDATION THREATENS TO SUE OVER FDA ADVERTISING POLICIES

The FDA is violating the First Amendment and federal law in establishing de facto limits on DTC advertising through warning letters, the activist group Washington Legal Foundation (WLF) argues. The group is threatening to sue the agency if its concerns are not addressed.

WLF sent an Aug. 7 citizen petition to the FDA challenging the agency's Division of Drug Marketing, Advertising and Communications (DDMAC) and Office of Compliance and Biologics Quality's handling of industry DTC advertising. The FDA is improperly limiting manufacturers' ability to make promotional claims and use disclaimers and is requiring duplicate materials, WLF said.

The group studied these offices' warning letters from June 2005 to June 2006 and released its results in the Aug. 7 report, "DDMAC Watch: The Year in Review." WLF concluded that the FDA is using warning letters to set DTC policies without going through the necessary public notice and comment procedures.

"Such letters are clearly being used to establish policy. This is suspect from a legal perspective, because federal law and FDA's own regulations generally require the agency to provide notice and opportunity for interested parties to comment before the agency communicates new regulatory expectations for the first time," the petition said.

WLF is demanding that the FDA review its DTC policies and practices and take steps to bring them into compliance with the First Amendment. The group is "contemplating litigation" if the agency "fails to take immediate steps to bring itself into compliance," WLF said.

The FDA "will review and consider the concerns stated in the petition, and will respond accordingly," an FDA spokeswoman said.