Comparative Claims: CFL Guidance Gives Opening; OPDP Research May Close It
US FDA’s 'consistent with labeling' guidance prompts more sponsors to consider comparative promotional claims, but any minimization of product safety issues still runs the risk of enforcement, legal experts say; Office of Prescription Drug Promotion’s research agenda on consumer understanding of Rx ad claims could result in an attempt to limit comparative claims.
You may also be interested in...
The apparently first-ever FDA press release for an advertising warning letter underscores importance of opioid issues – and the agency’s changing approach to media relations in general. FDA objects to Alkermes journal ad that excludes risk information about its opioid dependence treatment drug.
US FDA's wariness of taking enforcement action against Rx drug promotions may lead to more suits like GSK's. Complaint says healthcare providers are switching COPD patients to BI's Respimat inhaler in response to BI's marketing campaign.
An OPDP warning letter hits Galt Pharmaceuticals for misbranding its insomnia drug Doral with similar to concerns to those outlined in a 2014 untitled letter to the then-sponsor Sciecure.