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Presenting Risk and Efficacy Info in DTC Ads: FDA Drafts Guidance

Posted 16 October 2018 | By Zachary Brennan 

Presenting Risk and Efficacy Info in DTC Ads: FDA Drafts Guidance

Just a day after the Centers for Medicare and Medicaid Services proposed requiring drug prices in television ads, the US Food and Drug Administration (FDA) is offering industry guidance on how to present efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertising.

The 10-page draft guidance outlines FDA’s recommendations for how companies that include quantitative efficacy or risk information in DTC promotional materials can make the language and presentation “more consumer-friendly.”

Specifically, the draft guidance recommends, with examples, that firms display quantitative efficacy or risk information in numeric formats (“e.g., absolute frequencies or percentages; whole numbers; denominators with a base of 10”) and with appropriate context (“e.g., adding absolute frequency presentations to relative frequency presentations”); provide formatting considerations for illustrating quantitative efficacy or risk information in a visual aid; and include quantitative efficacy or risk information about the control group when it is provided for the treatment group in the ads.

“Quantitative information can improve consumers’ accuracy in estimating the drug’s benefits and risks,” the draft says. “Quantitative efficacy or risk information may offer more precision than qualitative information, which consumers can use to form more accurate perceptions about the drug.”

The examples in the guidance focus on absolute frequencies and percentages, relative frequencies, formatting quantitative efficacy or risk information, visual aids and quantitative efficacy or risk information from the control group.

The guidance follows a Nature study that said consumers perceive drugs to be less risky when ads for the drug list all of its side effects compared to when only serious side effects are listed. And in August 2017, FDA announced it is considering allowing drugmakers to limit the amount of risks presented in ads.

Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements: Draft Guidance for Industry

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