OPDP letters aren’t fun. They aren’t fun for the marketing and regulatory teams that receive the letter, and they aren’t fun for the agencies that need to scramble to review, identify, and update potentially violative pieces as quickly as possible. However, letters from OPDP do serve an important function for those of us whose job it is to understand and interpret the often nuanced world of pharmaceutical regulations.
Formal guidance from the FDA regarding pharmaceutical drug advertising and promotion is rare and, when it does come, is often lacking in clear direction. Guidance documents from 2014 answered some questions, but raised even more. In fact, we are still waiting on clear social media guidance that addresses a number of questions and concerns posed to the FDA. Rather, the FDA has released broad guidance that is supposed to be widely applicable across social digital platforms, but given the rapidly moving technologies that we often use, it is often difficult to apply this guidance to specific situations.
OPDP letters are critical for understanding OPDP’s point of view in lieu of formal guidance: They demonstrate OPDP’s reaction to very specific circumstances. Want to know when an unbranded, disease education website becomes a branded ad for a particular product? Check out the 2010 Gleevec letter.
Curious about what you can’t do in banner ads? The 2008 Diovan letter provides a solid clue. Have a question about what you can say when it comes to mechanism-of-action claims? The 2015 Abilify letter gives some good insight. Can you use Harris poll data to support a product claim? See the 2015 TussiCaps letter for direction.
Outside of formal guidance documents, pharmaceutical brand managers and those of us on the agency side should be frequently reading, understanding, and discussing OPDP letters. Some of the liveliest discussions we have at Fingerpaint center around whether OPDP was justified in its rationale for issuing certain letters. Some, like the recent Kim Kardashian Instagram post for Diclegis, are no-brainers, and no one here was surprised when a letter was issued. Others, like the 2014 Exparel warning letter (now withdrawn), resulted in a lengthy debate about the implications of a broad indication (e.g., surgical site) when the dosing and clinical studies sections of the product label are very specific (e.g., hemorrhoidectomy and bunionectomy). The back-and-forth over warning letters not only encourages discussion about OPDP regulations, it instills within our agency an understanding of how OPDP approaches its review of marketing materials. A little bit of schadenfreude is, of course, involved as well.
Because of the great learning experience that comes from reviewing these letters as an agency, the recent lack of letters is somewhat troubling. 2015 marked a record-low year, with only 9 letters being issued. The year ended with a letter-free period of nearly 5 months. Furthermore, many of the letters issued last year seemed to be the result of a complete lack of fair balance—violations that even the greenest of account executives should know to avoid. Yet another “Omission of Risk” letter underscores that OPDP is primarily concerned about egregious violations. Only a fraction of the letters issued last year were for those nuanced situations that provide great insight into OPDP’s mind-set.
OPDP insists that the recent downtrend in letters shouldn’t be used as an indication that it isn’t doing its job. For me, however, the recent trend of fewer OPDP letters isn’t as troubling as the trend of less substance in the letters. Outside of formal guidance documents, these letters are valuable tools for understanding where the true boundaries lie.
I don’t want any brands that I work on to get a warning letter. But, I wouldn’t mind so much if your brand does.
Ian DeMeritt heads up the medical team at Fingerpaint’s headquarters in Saratoga Springs. While he holds a PhD in microbiology and immunology and has mastered a lot of things (science, the written word, unicycle riding, the Rubik’s Cube, and marathons), space travel still eludes him. He’s applied multiple times to the NASA astronaut program, but has yet to make the final cut. But since he’s also mastered optimism, he couldn’t be more proud of his official NASA rejection letter.