Say so long to DDMAC as FDA's OPDP levels up
Under the restructure, DDMAC becomes the Office of Prescription Drug Promotion, a level-up that will mean more authority and resources for promotion oversight at the agency. OPDP continues to be led by Tom Abrams and includes a Division of Professional Promotion, led by acting director Catherine Gray, and a Division of Direct-to-Consumer Promotion, led by acting director Robert Dean. Mark Askine will serve as associate director of OPDP and Marci Kiester associate director of operations.
The Office of Medical Policy contains the Office of Prescription Drug Promotion and the Office of Medical Policy Initiatives, which is tasked with “coordinating medical policy regulations and guidances that address the policy and program areas covered by the Super Office,” including supporting the agency's Sentinel Initiative, Clinical Trials Transformation Initiative and Patient Medication Information Initiative. That office will also take in the Patient Labeling Team, formerly part of the Office of Surveillance and Epidemiology, which aims to “promote the safe and effective use of prescription medications by providing accurate and easily understood patient medication information.”
FDA announced the reorg in February, 2010, saying it would recognize the expanded scope of policy and promotion regulation at the agency in recent years.