Alan Minsk Quoted in Law360 Article Discussing FDA’s Final Rule Requiring TV and Radio Ads to Present Major Statement in a Clear, Conspicuous, and Neutral Manner

On November 27, 2023, AGG Food & Drug co-chair Alan Minsk was quoted in a Law360 article titled “FDA Rule Calls for ‘Dual Sharing’ of Side Effects in TV Ads.”

FDA’s new rule, which was initially proposed in 2010, establishes requirements that FDA will use to determine whether a direct-to-consumer (“DTC”) TV or radio ad’s major statement (risk information) about drug side effects is “clear, conspicuous, and neutral.” The rule also calls for “consumer-friendly language.” When assessing TV ads, FDA regulators will evaluate if the risk disclosure is delivered in dual formats (audio and text) simultaneously. Additionally, they will evaluate if there are distracting sounds or images that potentially interfere with the viewer’s ability to understand the message.

Alan told Law360 that although there are not a lot of new words in the regulation, it builds on FDA’s longtime push to evaluate ads from the perspective of what a consumer understands about the risks presented. The rule sends a message to industry to be mindful of how well a consumer will understand an ad’s disclosure statement.

“I think it’s telling industry, ‘We care about this issue. We will continue to care about this issue. And we’re going to remind you — it has to be understood, readily understandable, easily readable,'” Alan said.

While the new regulation targets TV and radio ads specifically, Alan said the rule may also prompt companies to think about social media communications as federal officials might turn their attention to other forms of DTC advertising.

To read the full article, subscribers to Law360 may click here.