AGG partner and chair of the Food & Drug practice, Alan Minsk, was quoted in a Law360 article discussing FDA’s increased enforcement activity around prescription drug advertising — a development drawing industry attention as the agency navigates staff cuts and leadership changes.
In the article, Alan offers insight into FDA’s recent uptick in enforcement letters from its Office of Prescription Drug Promotion (“OPDP”), suggesting that, “It could be that FDA — or at least OPDP — is trying to flex its muscles to say, ‘Even though everyone knows we’ve had layoffs, like other groups have had layoffs, we’re not lessening our enforcement.”
Alan also highlighted the importance of taking FDA’s early concerns seriously, advising that companies can minimize the risk of enforcement by proactively addressing feedback. “You don’t have to accept advisory comments,” he said, “but you’d be foolish not to seriously consider them.”
The article points to growing regulatory scrutiny over social media, repeated violations, and promotional claims tied to clinical data. Notably, two of the five enforcement letters issued in 2025 were warning letters — a step up from the more common violation notices issued in previous years.
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- Alan G. Minsk
Partner
