The Food and Drug Law Institute (FDLI) is hosting its annual Advertising & Promotion Conference for the Pharmaceutical, Medical Device, Biologic & Veterinary Medicine Industries this week in Washington DC. The conference kicked off this morning with the highly anticipated Food and Drug Administration (FDA) regulator panel that included Thomas Abrams, Director of the Office of Prescription Drug Promotion (OPDP); Lisa Stockbridge, Branch Chief of the Advertising & Promotional Labeling Branch, Office of Compliance and Biologics Quality (OCBQ); Toni Silfani, Consumer Safety Office at the Office of Compliance, Center for Devices and Radiological Health; and Thomas Moskal, Veterinary Medical Officer, Post-Approval Review Team, Division of Surveillance, Center for Veterinary Medicine.
Mr. Abrams highlighted the five current core focus areas of OPDP: policy and guidance development; labeling review; core launch reviews and TV ad reviews; enforcement; and training and communications. With regard to policy and guidance development, Mr. Abrams stated that OPDP is focused on revising current draft guidances, including the Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements and Presenting Risk Information in Prescription Drug and Medical Device Promotion. Mr. Abrams also assured the audience that OPDP is “highly committed” to providing “high quality” guidance related to promotion using social media.
Mr. Abrams also acknowledged the recent United States v. Caronia decision and stated that the FDA does not anticipate that the holding will impact the FDA’s enforcement activity under the misbranding provision of the Food, Drug, and Cosmetic Act (FDCA). Specifically, Mr. Abrams stated that no part of the FDCA or its implementing regulations was challenged.
All four speakers reviewed the most common violations in promotional materials, including omission or minimization of risk information, misleading superiority claims, misleading efficacy claims, and unapproved uses. Mr. Abrams focused on the recent PATADAY and INFASURF untitled letters, emphasizing that the OPDP conducts substantial review of clinical trial data in reviewing potentially problematic promotional materials. Ms. Stockbridge used the recent Regen-KIT-THT untitled letter and SmartPractice warning letter to demonstrate the recent enforcement activity of the OCBQ. Ms. Silfani discussed the use of direct telephone communications for enforcement, which has resulted in more immediate response times and increased compliance.
The FDA regulators return this afternoon for a Q&A panel discussion.