DDMAC to get upgrade in reorg

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DDMAC is being upgraded from a division to an office, an FDA official said yesterday.

Rachel Behrman, deputy director of FDA's Office of Medical Policy, announced a restructure of the unit that would consist of an office with two divisions. What's the difference? Basically, it's a step up in the agency's org chart.

“An office may consist of several divisions,” explained an agency spokeswoman. “These divisions report to the office heads.”

Details are still being worked out, but the general idea is that the office would hold a division handling the review of healthcare professional-directed materials and one handling the review of DTC advertising.

The unit would continue to be housed within the Office of Medical Policy and would be named the Office of Prescription Drug Promotion, DDMAC director Tom Abrams told Peter Pitts of Porter Novelli and the Center for Medicine in the Public Interest.

The move reflects an increased emphasis on policing promotion from agency brass as well as the growth of the division in recent years. DDMAC has been adding staff as the agency struggles to keep up with a flood of promotional materials submitted.

In April, the division added a third DTC review group, headed by Sangeeta Vaswani and covering consumer promotions for products in the oncology biologics, pulmonary and allergy, psychiatry and anesthetics, analgesics and rheumatology categories. A fourth DTC review group is planned as well.

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