As the end of the year nears, the pharma industry can usually look back at FDA enforcement letters for insight into the agency’s thinking and guidance on marketing communications. But this year, there’s not much to review.
The Office of Prescription Drug Promotion (OPDP) has issued only two letters so far in 2017. Last year at this same time, OPDP had issued five letters, with six more to come in December for a total of 11 warnings or untitled letters to drugmakers.
The number of letters sent by OPDP to pharma marketers has been in general decline for years. From a high of 156 letters in 1998, OPDP letters have dwindled since 2000. In 2015, the OPDP sent just nine letters to pharma companies for marketing violations, down from 10 in 2014 and 24 in 2013.
The two so far this year have been an untitled letter to Orexigen charging that its TV ad for weight-loss drug Contrave downplayed risks and a warning letter (PDF) to Cipher Pharmaceuticals over a professional detail aid for its opioid antagonist ConZip.
And while it’s “not yet certain” that this year will see “virtually no enforcement,” from OPDP, it’s “looking that way,” pharma and healthcare public relations professional Mark Senak wrote recently at his blog Eye on FDA. “…The trickle of visible enforcement raises questions. Why has there been a drop in enforcement activity? Does it represent a shift in emphasis or new policy?”
He noted that two emails he sent to the FDA asking those questions have gone unanswered.
Of course, OPDP may still have an end-of-year push up its sleeve, as it did last year with a flurry of letters in December. Two of the notable December letters went to Sanofi over diabetes drug Toujeo and Celgene over psoriasis treatment Otezla.
The ads were taken off TV at that time, but retooled versions of both have since returned to the airwaves. The OPDP complaints regarding both were similar, pointing to quick-cutting images and distracting music that it said undermined viewers’ ability to process and comprehend the risk and benefit statements.
Senak noted that while some people may attribute the drop to the current administration in charge, the decrease had begun long before the change.
“Does it mean that OPDP doesn’t care what is said in highly regulated speech? I would not count on it. They aren’t down to zero letters,” he said.