DDMAC sees ‘huge’ jump in number of ads submitted for review

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FDA Division of Drug Marketing, Advertising and Communications (DDMAC) director Thomas Abrams said that the agency has received “a huge increase” in print ads, TV and radio spots and scripts in the months since PhRMA called on companies to voluntarily submit ads for advanced scrutiny. Abrams made the comments during a marketing conference hosted by the Drug Information Association, a report on The Philadelphia Inquirer’s Web site said. “We have the same number of people,” handling a bigger workload, Abrams said. “At this point, it’s too early to tell how this will shake out.” PhRMA spokesperson Ken Johnson said in the report: “We understand they are kind of buried right now. But this is a clear indication that the companies are following through.” According to Abrams, most of the FDA’s 15 warning letters last year were prompted by inadequate warnings about a drug’s risks. He cited a journal ad for Quadrament, made by Cytogen, that he said falsely claimed to eliminate chemotherapy pain. “These are very, very sick patients and to promise them hope like this is not in the interests of the public health,” he said.
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