DDMAC DIVIDES TO CONQUER DTC WORKLOAD
The FDA is splitting up responsibilities for reviewing direct-to-consumer (DTC) ads based on the product type in order to better address a growing workload that is proving overwhelming for its staff, a high-ranking agency official says.
The FDA formally announced Sept. 19 that the Division of Drug Marketing, Advertising, and Communications (DDMAC) would split reviews into two groups and add an additional reviewer to its staff. These groups will review DTC promotions, including print and broadcast ads, direct mail brochures and pamphlets. The reviewers will also assess consumer-directed labeling disseminated to consumers through healthcare professionals.
Review group I will review ads dealing with oncology, medical imaging, hematology, dermatology, pulmonary, analgesics, rheumatology, metabolism, endocrine and gastroenterology products. Review group II will review DTC ads for neurology, psychiatric, cardiovascular, renal, reproductive, urology, anti-infective and antiviral products.
The reorganization is the latest step in the agency's effort to review these ads in a timely manner. As the number of ads submitted has risen, the agency's review times are getting longer, agency officials said.
The agency faces an "overwhelming" workload, Tom Abrams, the DDMAC director, said. Dividing these responsibilities is a better use of the agency's limited resources, he added. The agency is also negotiating with industry for user fees to support these reviews.