In a year that has seen relative few FDA Office of Prescription Drug Promotion (OPDP) warnings issued, it seems they are attempting to make up for lost time by issuing a warning late this month.
Amherst Pharmaceuticals and Magna Pharmaceuticals received OPDP letters “for making “false or misleading” claims on a website and at a trade show about their Zolpimist insomnia treatment.” The letter also included a reprimand for “failing to submit the proper FDA labeling form as required before promoting the drug.”
Having issued a total of 11 such warnings to drug makers last year, the OPDP is still far behind pace seeing as prior to this most recent warning, they had only issued two. One to Orexigen “charging that its TV ad for weight-loss drug Contrave downplayed risks” and one to Cipher Pharmaceuticals over a professional detail aid for its opioid antagonist ConZip.
Similar to how a pharmaceutical Brand name is scrutinized, the OPDP doesn’t have an overly exact method for how they evaluate what they call “violative materials.” Ultimately there is always going to be a certain level of subjectivity in the evaluation of the promotional aspects of a given pharmaceutical name or particular marketing initiative and, to some degree, that subjectivity is necessary in order to promote the safest environment for consumers. Although, that subjectivity makes for a potentially frustrating marketing world for drug companies.
From a naming perspective, there are several practices and innovative ways to help ensure successful pharmaceutical name approval, and even ways to fight back should a name be rejected. There has been a back-and-forth between pharma companies and the FDA long enough that there is at least somewhat of an understanding as to what is expected from a safety and regulatory standpoint. But, when it comes to promotional materials or advertisements, the OPDP’s powers appear to be growing, and perhaps will need to keep doing so in order to keep up with the new ways in which these companies are attempting to touch and speak to consumers.
Last year, for example, the India-based Company Zydus was scrutinized by the OPDP for a YouTube video they posted that about their drug Libaglyn which made the product seem as if it was approved throughout the world by using phrases like “the world’s first” and “first-in-class therapy.” Problem was, it was not approved by the FDA yet, and Zydus was asked to remove the video.
The OPDP has chastised companies for websites that fail to mention a full list of potential side-effects, email campaigns that don’t include full risk information, and these are just two of seemingly innumerable variety of things the office can scrutinize. Moving forward, it will be imperative that the healthcare industry maintain a strict watch on all of their branding and marketing efforts in order to keep potential conflict with the FDA at a minimum and, as always, developing a relationship with an expert branding agency can help with navigating these potential pitfalls.