FDA Issues New Draft Guidance On Medical Product Communications

Federal regulators have proposed new draft guidelines about the labeling and warnings for medical products, which are designed to make sure manufacturers accurately portray safety information in advertising and other promotional materials. 

The FDA published the new draft guidance (PDF) in a notice in the Federal Register on January 19, directing drug makers and medical device manufacturers about best practices to make their advertising consistent with FDA-required labeling, particularly when they are talking about information that is not actually on those labels.

At issue are efforts by drug manufacturers and medical device makers to get the agency to relax some of its rules on “off-label marketing.” Medical product manufacturers are only currently able to promote their drugs for uses approved by the FDA. Any promotions outside of that, which appear to be promoting the drug for an unapproved use, could get the drug labeled as misbranded, adulterated, and could result in the company being cited for false and misleading advertising.

Manufacturers have been trying to push the agency to allow them to communicate to doctors studies and other data which suggest that drugs may work effectively for other uses, even when they have not yet received FDA approval for those uses, arguing that as long as the information is accurately presented, they should not run afoul of the agency’s rules.

The new guidance describes the agencies thinking to manufacturers on where those lines are drawn regarding what the FDA considers false statements, and how to present data not on the label in a way that will not get manufacturers into trouble.

“Medical product firms have told FDA that they are interested in communicating, including in their promotional materials, data and information about the approved/cleared uses of their products that are not contained in their products’ FDA-required labeling,” the guidance states. “We also recognize that firms have questions about how FDA determines when communications that contain data and information that are not in the FDA-required labeling are consistent with the FDA-required labeling, and how such communications are viewed by FDA.”

The guidance covers a number of scenarios in question and answer format to assist companies in staying within the agency’s rules. The guidance is not a binding regulation.

The FDA is taking public comment on the guidance for 90 days.