Julie Tibbets, partner in the firm’s Health Care Group, spoke at a Food & Drug Law Institute’s Advertising & Promotion conference and discussed how the FDA Center for Drug Evaluation and Research’s Office of Prescription Drug Promotion (OPDP) issued one warning letter and 18 “untitled” letters from October 2012 to September 2013. Her comments were featured in Bloomberg.
“Compared to prior years, this is a downward trend in letters, especially in warning letters,” Tibbets said.
Tibbets also mentioned that there are few instances where OPDP issued letters that did not mention risk and data presentations.
“Focus your legal and regulatory resources on risk and data presentations” in advertisements and don't overlook investigational product materials and websites, she said.
Tibbets also advised that companies should partner with marketing team members to ensure risk presentations get equal time and attention in promotional materials during the drafting stage, including labeling; lean on medical reviewers to understand study designs and the limitations for supporting data; not overlook investigational product materials and websites; ensure product-related press releases undergo multidisciplinary review; and inventory claims supported by composite score data for overstatement of efficacy.
She also said that companies should keep an eye out for the FDA’s direct-to-consumer advertising composite score study results “to inform future benefit presentations of score-based claims.”