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Monday, March 11, 2013

OPDP Reorganization: Will It De-emphasize DTC Ad Review?

FDA's Office of Prescription Drug Promotion (OPDP) is being re-organized. Instead of separate divisions for consumer promotion (direct-to-consumer or DTC promotion) and professional (HCP) promotion, there will be two divisions focused on ALL advertising but organized around therapeutic categories.

"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 (reported via MM&M here).

"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."

I don't really see how this reorganization improves the efficiency of reviewing DTC advertising. It seems, rather, to de-emphasize oversight of DTC by mixing it with oversight of physician promotion. I'd like to hear your opinion on this.

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