The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
Dear Colleague:
In follow-up to the announcement below concerning changes in the Office of Prescription Drug Promotion, please see the updated list of reviewers and their new assignments: OPDP Organization Listing
Sincerely,
Office of Prescription Drug Promotion
I would like to make you aware of changes in the Office of Prescription Drug Promotion (OPDP), Office of Medical Policy. 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.
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.
We know that DTC advertising is often the catalyst for patients initiating conversations with their physicians about their untreated or undertreated conditions. It is also a subject of interest and debate among our stakeholders. 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.
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.
Janet Woodcock
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