On August 4, 2023, the Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued a Warning Letter to AstraZeneca which stated that the company made misleading claims in a promotional sales aid about the effectiveness of BREZTRI AEROSPHERE™ (“Breztri”). Given that it has been almost a year and half since OPDP issued a Warning Letter (the last Warning Letter was issued in February 2022), the takeaways here are significant for industry and provide insight into how FDA will examine efficacy claims that are so-called “consistent with label” and require compliance with FDA’s June 2018 guidance (the “CFL Guidance”).[1],[2] Going forward, we expect the agency’s focus to remain on product communications to the public—to either a general consumer or professional audience—and whether those communications include essential contextual information to avoid the potential that such claims could be viewed as misleading.Continue Reading Context is Key: FDA Sends a Strong Message About Efficacy Claims