Kellie Combs Examines FDA Scrutiny of Drug Advertising and Promotion

At a Drug Information Association conference on advertising and promotion regulatory affairs covered in a Pink Sheet article, life sciences regulatory & compliance partner Kellie Combs discussed key takeaways from recent warning and untitled letters issued by the U.S. Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP).

Kellie observed that several themes are emerging from recent OPDP letters, including a focus on misleading efficacy claims, FDA scrutiny of the data underlying promotional claims, and the importance of crafting clear and robust disclaimers regarding the data and any limitations.

Kellie also discussed OPDP’s recent focus on consumer-directed materials, particularly in cases where the data are subject to significant limitations. “If you have got an exploratory analysis, from FDA’s perspective, you are not going to be able to make unmitigated conclusions or claims about the results and what that means,” said Kellie.