FDA Launches “Bad Ad” Program

The U.S. Food and Drug Administration (FDA) is launching a “Bad Ad Program” intended to help health care providers detect and report <"https://www.yourlawyer.com/practice_areas/defective_drugs">misleading drug ads.

The program is also designed to educate health care providers about their role in ensuring that prescription drug advertising and promotion is truthful, and not misleading.

The Bad Ad Program is an FDA-sponsored educational outreach effort administered by the agency’s Division of Drug Marketing, Advertising, and Communications (DDMAC), in the FDA’s Center for Drug Evaluation and Research.

“The Bad Ad Program will help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency,” said Thomas Abrams, director of DDMAC.

The program will be rolled out in three phases, as follows:

• Phase 1: DDMAC will engage health care providers at specifically selected medical conventions and partner with specific medical societies to distribute educational materials.

• Phases 2 and 3: Will expand the FDA’s collaborative efforts and update the educational materials developed for Phase 1.

The FDA’s traditional regulatory activities for monitoring prescription drug promotion primarily rely on review of promotional pieces submitted to the agency by sponsoring drug companies, industry complaints, and field surveillance at large medical conventions. Although these efforts are effective, the agency has limited ability to monitor promotional activities that occur in private.

Health care professionals are encouraged to report a potential violation in drug promotion by sending an email to badad@fda.gov or by calling 877-RX-DDMAC.

Reports can also be submitted anonymously; however, the FDA encourages providers to include contact information so that DDMAC officials can follow-up, if necessary.

Additional information on the program can be accessed on the FDA Web site at this link.