DDMAC vows pushback on risk disclosures

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The FDA has stepped up efforts to combat what it sees as the No. 1 pharmaceutical marketing compliance problem, said Division of Drug Marketing, Advertising and Communication chief Thomas Abrams: ads that omit or downplay risk information.

Among reasons cited for DDMAC’s stepped-up enforcement: pharmaceutical marketers are more often “pushing the envelope,” including stressing drug benefits but not presenting adequate risk information, said Abrams, speaking at the Drug Information Association meeting in New York last month. The same holds true of ads promoting biotech products, reported Elenita Ibarra Pratt, who heads FDA’s Advertising and Promotional Labeling Branch, the biotech counterpart to DDMAC.

 “There appears to be a lack of attention on risk information, as the focus is so much on benefit,” Abrams said. “Many people… are devoted to the marketing strategy of selling the drug by refining the benefit message. I think we need to put more of this expertise into the presentation of risk information in promotion.”

While more drug firms are engaging in aggressive promotion, Abrams said that instances of stressing efficacy at the expense of risk are “not many cases at all.” Nevertheless, “This is not in the public interest and is short-sighted when it does happen.”

FDA guidance on risk information, he said, is due to be issued in June.

FDA has come under heightened scrutiny for its efforts to ensure drugs are safe as advertised. The Institute of Medicine, in a set of recommendations issued in September, said that the FDA needs more resources and more regulatory authority to approve and monitor consumer promotion. Abrams addressed that concern, saying that even with the recent transition of two journal ad reviewers to the DTC side, his division’s increased workload has outpaced the resources dedicated to reviewing ads. Judging by the number of warning letters addressed to consumer promotions, the PhRMA DTC guidelines seem to be working.

Last year the agency sent out 14 warning letters to drug marketers, one less than its total in 2005 (before which the yearly average was four to five warning letters per year). Since the passage of the PhRMA guidelines, however, the locus of that effort seems to have shifted to promotions targeting doctors. Just one 2006 letter cited a consumer-directed piece—for GlaxoSmithKline’s Zovirax—while 13 were for promotional pieces directed to healthcare professionals. That’s a shift from 2005, when five warning letters targeted consumer materials vs. 10 taking issue with professional matters.

Abrams nonetheless cautioned against judging the code’s effectiveness at this point. “A year is not enough time,” he said. “We are hopeful the guiding principles will have a positive impact on DTC.”

Asked what he would tell drug marketers with regard to pushing the envelope, Abrams, who once worked for the drug industry, said, “I have a tremendous respect for marketing people, but let’s do the right thing. I think you can sell a drug and do it the right way.”

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