FDA finalizes guidance on quantitative efficacy and risk info for DTC promotional labeling, ads

The US Food and Drug Administration (FDA) has published final guidance on presenting risk and efficacy for direct-to-consumer (DTC) promotional labeling and advertisements for prescription drug and biologic products for humans and drug products for animals.

The aim of the final guidance is to provide recommendations for companies on how to create advertisements and promotional materials for DTC drug and biologic products with “consumer-friendly” language and presentation, which includes information on presenting probability, formatting quantitative efficacy and risk information, and use of visual aids.

FDA’s guidance, which finalizes a draft guidance released by the agency in October 2018 under the same name, adds “clarifying considerations for quantitative efficacy or risk presentations across various media types” as well as further explanation in examples from the draft guidance and the addition of organizational and editorial changes to the text. (RELATED: Presenting Risk and Efficacy Info in DTC Ads: FDA Drafts Guidance, Regulatory Focus 16 October 2018)

Drug promotion and labeling are required to be truthful and not misleading while also informing the consumer about efficacy and risks, but companies “generally have flexibility with respect to the presentation of efficacy and risk information about their products as long as the presentation is not false or misleading and complies with other applicable statutory and regulatory requirements,” the agency wrote.

However, FDA also acknowledged that it can be challenging for companies to present quantitative efficacy and risk information in DTC promotional communications for consumers. In addition, the agency noted they have seen more submissions involving quantitative presentations of efficacy and risk information in DTC promotional communications. be

The use of quantitative information may help consumers “form more accurate perceptions about the drug” FDA wrote.

“When compared to qualitative descriptions of efficacy and risk information, quantitative information can improve consumers’ accuracy in estimating the drug’s benefits and risks,” they said. “This is due in part to how consumers differ in their interpretations of qualitative descriptors (e.g., rare, common, most) and how the context in which qualitative terms are presented can affect how consumers understand them.”

Companies should present quantitative efficacy or risk information for studies that involve both a treatment group and a control group, the agency said. For presenting probability, consumers are more likely to understand absolute frequencies and percentages, whereas they may find “the efficacy or risk probability described as a relative frequency harder to comprehend and more favorable as compared to the absolute frequency.”

“If firms choose to present efficacy or risk probabilities as relative frequencies, they should add context to the relative frequency presentation to improve consumers’ ability to accurately understand the efficacy or risk information,” FDA said.

In terms of formatting quantitative efficacy or risk information, companies should present information in a consistent manner, such as using the same numerical format and frequencies with the same denominator. The formatting of probability information in promotional communication should not minimize risk severity of a drug or biological product; labeling or promotions “should avoid presentations that focus attention on the low probability of a serious risk occurring, that characterize the probability of that risk occurring as insignificant, or that otherwise suggest that the risk is not important based on its probability of occurring.”

FDA recommended companies “carefully consider the communication’s purpose and objectives” when selecting a visual aid for presenting quantitative efficacy or risk information about a drug or biologic, such as using a bar graph for comparing probabilities and a bar graph for visualizing changes over time. Visual aids should be clearly labeled, numeric information should be proportional to what’s being described, and numerator and denominator should be included in visuals of ratios or frequencies.

Final guidance, Federal Register notice

FDA finalizes guidance on quantitative efficacy and risk info for DTC promotional labeling, ads

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