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FDA Considers More Targeted Risk Information in DTC Ads


FDA is evaluating whether limiting warnings in TV commercials to the most serious adverse effects might be more informative for consumers than the current laundry lists of potential side effects.

FDA is conducting in-house research to help evaluate whether limiting warnings in TV commercials to the most serious adverse effects might be more informative for consumers than the current laundry lists of potential side effects. A current study by FDA’s Office of Prescription Drug Promotion (OPDP) of comparative price information in DTC and professional print ads, for example, finds that most consumers and physicians fail to notice or understand disclosures about the limitations of such cost data, even when the caveats are prominently displayed, according to OPDP research team lead Kathryn Aikin.  This raises questions about the effectiveness of current policies and if there are better ways to inform consumers and health professionals about the limitations in price comparison messages, Aiken noted at the recent advertising and promotion conference sponsored by the Food and Drug Law Institute (FDLI) in Washington, D.C.

Such research findings can help FDA understand how consumers and prescribers respond to risk and benefit information in promotional messages and where the agency should seek to revise advertising and marketing policy. Industry has complained that much of OPDP research is redundant and uninformative. But FDA commissioner Scott Gottlieb stated in August that internal studies may help the regulators better understand what risk information is most useful in DTC advertising and devise policies on risk disclosure that best inform consumers of “the key potential tradeoffs of using a prescription medicine”. Analysis indicating that consumers may retain more risk information from targeted statements may support an FDA proposal to limit the risks cited in DTC ads to severe, serious or actionable side effects, coupled with an alert that additional product risks are not included in the statement. Comments are due mid-November.

Another OPDP study in this area is examining how larger size and clearer presentation of text running in TV commercials may be better understood and remembered by viewers. There’s a project assessing how animated TV ads improve understanding of risk information and one exploring ways to better design DTC ads for older and hearing impaired audiences, possibly by slowing down and simplifying “major statements.”  

A surprising finding from another OPDP study is that marketer presentations of clinical trial data and research findings in drug promotional materials for professional audiences are not well understood even by highly educated specialists. In interviews with primary care physicians and endocrinologists across the U.S., researchers found that many doctors could not correctly define “randomized controlled trial,” and that majorities did not fully understand terms such as  “re-randomization” and “non-inferiority randomized controlled trial.” The docs fared even worse in trying to define less common terms such as “ modified intent-to-treat,” “adjusted mean” or “last observation carried forward.”

Although only a small number of physicians were queried, the results indicate that these professionals have a low-to-moderate familiarity with specific research concepts used in promotional materials such as sales aides, reported OPDP analyst Helen Sullivan at the FDLI conference. Sullivan and colleagues hope to follow up with further research on how clinical trial data presented by marketers affect physicians’ attitudes and decision-making.



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