OPDP takes an integrated approach to ad reviews

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Pharma marketers and their agencies have been talking forever about shedding the silos that house their consumer- and professional-facing promotional efforts. Now FDA is getting in on the game.

The agency's Office of Prescription Drug Promotion used to have separate divisions for consumer and professional-facing promotion. Now, they're shuffling the deck to form two divisions, organized around therapeutic categories, that will review both consumer and professional promotion.

“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,” said Center for Drug Evaluation and Research head Janet Woodcock in a statement. “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.”

Pending approval, the Office will house two review groups, each composed of four teams assigned a therapeutic area. Division I, led by acting director Andrew Haffer, will tackle promotional materials for products in neurology/psychiatry; hematology; oncology; and analgesics, anesthetics and antivirals. Division II, led by director Robert Dean, will look at ads for treatments in osteoporosis, reproductive and urology; dental, dermatology, metabolic and endocrine; allergy, gastroenterology, pulmonary and rheumatology; and anti-infective, cardiovascular, medical imaging, ophthalmology, renal and transplant. Here's the org chart.

“We know that DTC advertising is often the catalyst for patients initiating conversations with their physicians about their untreated or undertreated conditions,” said Woodcock's statement.  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.”

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