Alan Minsk Quoted in Law360 on FDA’s Increased Scrutiny of Drug Advertising

Alan Minsk, AGG Food & Drug practice chair, provided insight into FDA’s recent enforcement activity targeting direct-to-consumer drug advertisements that imply unproven quality-of-life benefits in a recent Law360 article.

The article discusses an Untitled Letter issued to a pharmaceutical company concerning a commercial for a weight loss pill that regulators allege suggested emotional and lifestyle benefits not supported by evidence.

Alan explained that drugmakers should expect regulators to scrutinize broad assertions that are not grounded in clinical data.

“It probably is true to some extent that patients do find that if the product works for X, I’m probably feeling better about Y and Z,” he said. “But FDA would take exception that you don’t have data to support that.”

Alan added that regulators are focusing on high-profile targets, knowing other drugmakers will pay attention.

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