New DDMAC group added to review DTC

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The Division of Drug Marketing, Advertising & Communication (DDMAC) has added a second DTC review group to meet soaring demand for advertising approvals, said DTC group leader Melissa Moncavage. DDMAC fielded 9,285 consumer promotions in 2005 – up from 8,417 in 2004 and 6,099 in 2003. The number of DTC ads submitted is expected to climb again for 2006. The second group, consisting of three reviewers and acting leader Christine Smith, will handle ads for neurology, psychiatry, cardiovascular, renal, reproductive , urology, anti-infective and anti-viral products. Moncavage’s five-person team, including two reviewers and two social scientists, will cover those for oncology, medical imaging, hematology, dermatology, pulmonary, analgesic, rheumatology, metabolism, endocrine and gastroenterology products.  The addition of the second DTC review team, first reported in The Pink Sheet, has fueled discussion between the agency and industry of a possible increase in PDUFA user fees. DDMAC also maintains four review groups dedicated to professional advertising. The agency received 39,153 pieces of professional promotion for review in 2005.
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