Life Science Compliance Update

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March 29, 2013

FDA Reorganizing Office of Prescription Drug Promotion

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Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) announced a new restructuring of FDA’s Office of Prescription Drug Promotion (OPDP).  As we noted back in the fall of 2011, FDA reorganized its previous office—the Division of Drug Marketing, Advertising, and Communications (DDMAC) into OPDP. 

OPDP works to protect the public health by ensuring that all prescription drug promotional labeling and advertising directed to health care professionals and consumers is truthful, balanced, and not misleading.  

Shortly after launching OPDP, the office created a new “Bad Ad Program,” which subsequently issued a few yearly reports about its progress in educating physicians and “deputizing” them to report fraudulent or questionable detailing or advertising.  

Recently, OPDP reviewed and analyzed the workload and review processes in its two divisions, the Division of Consumer Drug Promotion, and the Division of Professional Drug Promotion, in an effort to improve upon their overall impact and effectiveness.  The goal of this analysis was to increase efficiency, improve work distribution, and eliminate redundancy.   

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. 

Toward this goal, OPDP will be restructuring its divisions and, pending final approval, will rename them the Division of Advertising and Promotion Review I and the Division of Advertising and Promotion Review II.  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. 

Woodcock acknowledged the importance of DTC ads, and noted that it is “often the catalyst for patients initiating conversations with their physicians about their untreated or undertreated conditions.”  Woodcock noted that the “decision to restructure the divisions reflects our commitment to continue providing close oversight of DTC advertising. The new structure will improve efficiency in our program area and our ability to meet the health needs of the American public.”  

Finally, she noted that “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.” 

Whether this new restructuring will help in speeding up the issuance of the long-awaited Social Media guidance is yet to be seen.   

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