Discussing Trends in OPDP Enforcement Letters to Avoid Infractions

Julie Tibbets presented at this webinar hosted by Regulation Station. 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 and 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 took 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

Participants that found this webinar most beneficial to those involved in pharmaceutical and biotechnology companies. Job titles of attendees that will be most applicable for this session were: 

    •Regulatory Affairs 
    •Advertising & Promotions Compliance 
    •Legal Counsel 
    •Compliance Officers

This webinar was pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 1.5 credits toward a participant’s RAC recertification upon full completion.

Tuesday June 24, 2014
 11 a.m. EST to 12:30 p.m. EST