Polsinelli - FDA Regulatory


May 2014


Changes Coming to Prescription Drug Advertising







FDA Regulatory Practice Leaders:


Melissa Gilmore





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FDA Developing New Risk and Benefit Perception Scale

On April 21, 2014, continuing its scrutiny of the disclosures of risks and benefits in prescription drug advertising, FDA announced a plan to conduct a study "designed to test different ways of measuring consumers' benefit and risk perceptions after exposure to direct-to-consumer (DTC) prescription drug advertising."

The proposed study, "Risk and Benefit Perception Scale Development," contains two phases. The pre-testing phase involves 1,000 individuals divided into two groups: one group of individuals diagnosed with chronic pain, and one group of individuals diagnosed with hypertension. Each individual will be randomly assigned to view a print or television advertisement for a fictitious prescription drug indicated to treat chronic pain or hypertension. After viewing the advertisement, each individual will be asked a series of questions designed to assess his or her benefit/risk recall, benefit/risk perceptions, and attitudes toward the drug. Based on the individuals' responses to the advertisements in the pre-testing phase, certain advertisements will be revised or removed before the second stage of proposed testing.

The second stage involves 10,000 individuals divided into four groups: one group of individuals diagnosed with chronic pain, one group of individuals diagnosed with hypertension, and two groups with neither chronic pain nor hypertension. Each individual will be randomly assigned to view an advertisement that has been manipulated into one of the following five conditions: high benefit/high risk, high benefit/low risk, low benefit/high risk, low benefit/low risk, and a control advertisement that contains no information regarding risks or benefits. As with the pre-testing phase, after viewing the advertisement, the individuals will answer a series of questions designed to test their perceptions. The public comment period for the proposed study ends on June 20, 2014 .

New Guidances Pending

FDA plans to publish several new and revised draft guidances in 2014, including six advertising-related draft guidances and several related to how risk and benefit disclosures must be handled in social media, television, and print advertisements. But although FDA says that the proposed Risk and Benefit Perception Scale Development study stems from research that "suggests that consumers struggle with the concepts of risk and efficacy . . . and often overestimate drug efficacy," advertisers of prescription drugs should not necessarily expect that FDA will require greater disclosures of drug risks. In February of this year, FDA announced its plan to conduct a similar study to measure the efficacy of television advertisements. In that announcement, FDA stated its concern that "as currently implemented in DTC ads, the major statement [regarding a product's risks] is often too long, which may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic noncompliance due to fear of side effects." FDA recognized that there were "conflicting viewpoints" at play, noting that "[a]t the same time, there is concern that DTC TV ads do not include adequate risk information or leave out important information." That proposed study hypothesized that a middle ground of "providing limited risk information along with [a] disclosure about additional risks," as opposed to providing a laundry list of warnings, would "promote improved consumer perception and understanding of serious and actionable drug risks."

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*Law360, March 2014







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