Following an 18 month approval process, Director Janet Woodcock announced in an email to Center for Drug Evaluation and Research (“CDER”) staff on Monday, September 19th that the Division of Drug Marketing, Advertising and Communication (“DDMAC”) is now reorganized and elevated into the newly formed Office of Prescription Drug Promotion (“OPDP”). FDA first announced that it was considering the elevation of DDMAC to office status in February 2010. Given the size of DDMAC, FDA no longer considered the designation of division appropriate. This recent elevation and reorganization comes as CDER’s Office of Medical Policy undergoes a transition into a super office, which continues to be led by Rachel E. Behrman, Director of the Office of Medical Policy.
The new OPDP will house two divisions, the Division of Professional Promotion and the Division of Direct-to-Consumer Promotion. The reorganization did not involve a change in leadership. Thomas Abrams will be the Director of OPDP with Mark Askine as the Associate Director, Marci Kiester as Associate Director of Operations, Catherine Gray as Acting Director of Division of Professional Promotion, and Robert Dean as Acting Director of Division of Direct-to-Consumer Promotion.
The regulated community waits with baited breathe to see if these monumental changes result in equally monumental shifts in regulations and enforcement. Perhaps OPDP’s first regulatory act will be to issue the long promised internet and social media rules.