The FDA’s Prescription for Balanced Messaging Applies Beyond Pharma

AGG Food & Drug attorneys, Alan Minsk, Laura Dona, and Grace Gluck, authored an article for Corporate Compliance Insights discussing FDA’s new compliance expectations for direct-to-consumer drug promotion. FDA has put focus on consumer understanding of disclosures rather than their simple existence for the pharmaceutical sector. The Administration has increased scrutiny of both digital-native and influencer marketing, specifically to avoid false or misleading benefit claims.

Alan, Laura, and Grace examined how FDA compliance crackdowns reflect regulation trends across a number of sectors in which enforcement is increasing. They highlighted that, “all organizations communicating value to consumers must be prepared for regulators to evaluate whether the consumer is reasonably likely to misinterpret a claim, whether the risks and limitations of a product or service are adequately disclosed and whether the company made good-faith efforts to ensure accuracy before dissemination.”

To offer practical insight, the attorneys outlined key lessons for all corporate compliance programs, specific compliance recommendations for pharmaceutical companies, and compliance takeaways beyond the pharmaceutical sector.

“As regulators continue to focus on transparency and accountability, companies should assume that more scrutiny of consumer-facing messaging is coming, not only in pharmaceuticals but across sectors where claims about benefits, performance or risk mitigation influence consumer decision-making,” recommended Alan, Laura, and Grace.

To read the full article, please click here.