DISCUSSING TRENDS IN OPDP ENFORCEMENT LETTERS TO AVOID INFRACTIONS

According to a recent Office of Prescription Drug Promotion (OPDP) webinar, the FDA stated that it does not see any new non-compliance trends among pharmaceutical advertising at this time; but does commonly observe overstatement of efficacy, minimization/omission of risk, unsubstantiated claims as well as pre-approval promotions. Pharmaceutical executives are looking to uncover and evaluate these and other reoccurring trends among recent warning letters, in order to create and maintain a proactive approach in meeting regulatory requirements. Offending drug companies must engage in corrective advertising; as failure to correct violations cited in a warning letter can result in FDA regulatory action, including seizure or injunction. Attendees will take away from this session:

• A delineation between an untitled letter and a warning letter
• Recognition & dialogue regarding infamous citations
• Unique strategies utilized to avoid warning letters

Speaker:
Julie Tibbets
Partner
Alston & Bird LLP

Contact:

Brooke Akins | Manager, Market Intelligence | 312.224.1693 webinars@q1productions.com