Regulatory Focus™ > News Articles > FDA Announces Reorganization of Advertising Regulators, Will Divide Into Product Specialties

FDA Announces Reorganization of Advertising Regulators, Will Divide Into Product Specialties

Posted 08 March 2013 | By

US regulators are preparing to reorganize the Office of Prescription Drug Promotion (OPDP), the first major change to the office since its promotion to a super office and a name change from the Division of Drug Marketing, Advertising and Communications (DDMAC) in September 2011.

The office, a sub-division of the Center for Drug Evaluation and Research (CDER), is charged with reviewing advertising for pharmaceutical and some biological products, as well as their various promotional materials. The office is perhaps most visible for its "Untitled Letters," which often provide insight into its views on accurate labeling, patient testimonials, online and television videos, and magazine-based advertising.

The agency has also recently (May, 2010) implemented a "Bad Ad Program," which is intended to reach out to healthcare providers and other professionals-those most likely to be the recipients of drug advertising-to encourage them to report promotional materials they feel are not in compliance with FDA regulations.


In 2011, the office was given a promotion, rising from a regular department to a so-called "Super Office" within CDER, usually done to reflect an area's heightened importance within a center and to give it more resources and authority with which to complete its goals and directives.

Now FDA is preparing to re-organize staff within the center, reportedly after an FDA assessment determined that a more efficient structure would allow it to be less redundant and more effective.

"Through the analysis, OPDP concluded that a structure that integrates the review of health care professional-directed and consumer-directed promotion across the two divisions would meet this goal," the office wrote in an emailed statement.

Accordingly, OPDP said it will divide its resources into two review divisions: the Division of Advertising and Promotion Review I (DAPR I) and II (DAPR II).

Specialized Divisions

Both divisions will handle health care and consumer promotion. As a way to distribute the work evenly, each division will oversee different therapeutic classes of drugs. These changes will allow OPDP to review direct-to-consumer (DTC) and health professional advertising more effectively.

DAPR I will be led by Acting Director Andrew Haffer and Acting Deputy Director Lisa Hubbard, and will include teams covering neurology, psychiatry, hematology, oncology, analgesics, anesthetics and antiviral products.

DAPR II will be led by Director Robert Dean and Acting Deputy Director Michael Sauers, and will include teams covering osteoporosis, reproductive, urology, dental, dermatology, metabolic, endocrine, allergy, gastroenterology, pulmonary, rheumatology, anti-infective, cardiovascular, medical imaging, ophthalmology, renal and transplant products.

"The decision to restructure the divisions reflects our commitment to continue providing close oversight of DTC advertising," wrote Janet Woodcock, director of CDER, in the statement. "The new structure will improve efficiency in our program area and our ability to meet the health needs of the American public." 

"Our ODPD reviewers will continue to use a comprehensive surveillance, enforcement, and education program to foster superior communication of labeling and promotional information to both health care professionals and consumers," Woodcock added.

The OPDP team will continue to be led by Thomas Abrams, director and Associate Directors Mark Askine and Marci Kiester.


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