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9_Direct to consumer advertising in oncology - Abel et al.

9_Direct to consumer advertising in oncology - Abel et al....

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Abel, Penson, Joffe et al. 225 www.TheOncologist.com Recent Developments In February of 2004, the FDA issued a draft Guidance for Industry regarding the information included in the brief summary portion of direct-to-consumer advertisements [29]. Several pharmaceutical advertisers have responded by changing their practice of reprinting their approved package insert and now include more patient-friendly explanations of possible side effects. The FDA also recently issued Draft Guidances for industry comment purposes on consumer-directed broadcast advertising of restricted medical devices [30], as well as help-seeking and other disease awareness communications by or on behalf of drug and device firms [31]. Such developments, especially the possibility of clearer language for the brief summary, were cautiously applauded, notably in a Janu- ary 2005 perspective piece in The New England Journal of Medicine [32]. In July of 2005, Senator Frist, a former practicing physi- cian, called for a 2-year ban on direct-to-consumer adver- tising and asked for the Government Accounting Office to study the issue. [2] Dr. Frist’s suggestion was not taken
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