Risk and Restrictions - Pharmaceutical Executive


Risk and Restrictions

Pharmaceutical Executive

More Studies and Guidance

DDMAC researchers are very busy these days. In addition to the brief summary survey, there's a study underway evaluating whether TV commercials should include a toll-free number for consumers to report adverse events to FDA. FDAAA required call-in information in print ads, but held off on broadcast to assess whether adding this message would detract from conveying risk information in commercials. FDA is revising study designs with an eye to rolling out a survey next year.

Another research project is examining how visual effects in TV commercials distract consumers and impede comprehension. The results should help FDA set standards for how marketers can best present a "major statement" on drug risks in DTC ads in a "clear, conspicuous and neutral manner," another FDAAA provision that should produce a proposed rule next year.

A related study will examine how well consumers understand clinical efficacy information in print and broadcast ads. The plan is to survey physicians and consumers to see how differently (or similarly) they perceive such information. Also on DDMAC's agenda is a plan is to assess whether adding quantitative information on risks and benefits can help consumers understand risk and efficacy claims and end point information. And another FDAAA-required report will assess how well DTC advertising communicates information to population subsets, such as the elderly, children, and ethnic minorities; DDMAC director Tom Abrams expects it to be out soon.

Meanwhile DDMAC is ramping up enforcement efforts to ensure proper disclosure of drug risks. Abrams reported at the FDLI conference that it had issued 33 regulatory letters as of September 15, 2009 (10 warning letters and 23 untitled letters). Omission and minimization of risk information is the most egregious violation, followed by promoting unapproved uses.

FDA hopes to reduce those violations by finalizing guidance on presenting risk information in drug and device promotion. FDA issued draft guidance in May 2009 that covers the risk-communication waterfront: safety disclosure in ads and labeling for both drugs and medical devices, directed to both consumers and health professionals. The guidance cites multiple examples of promotional pieces that omit or minimize risk information, even for products with boxed warnings and serious adverse events. FDA discusses in detail the content and format of promotional materials and how it will look more at the "net impression" of whether risk information is fair and balanced.

Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at


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