FDA's marketing police wrote only 10 tickets in 2014

In the realm of drug industry enforcement, the Office of Prescription Drug Promotion is like a meter maid. OPDP citations aren't as scary as warning letters from other FDA enforcers that can shut down a manufacturing plant or clinical site. And they certainly aren't subpoenas from the Justice Department.

Even so, no one wants to be the recipient of an official violation notice from OPDP. They can cost money; just ask Bayer, which had to run a bunch of corrective advertising after FDA's promotional police took issue with claims in its Yaz advertising. But for everyone else, the office's missives are like telegrams. Or coded messages interlined in invisible ink, given that they need to be deciphered first, and then held up to the light for any subtextual, hidden meaning.

People actually make their living doing that sort of FDA analysis. For them--and for those of us who like to keep track of the agency's thinking on various marketing-related subjects--the last year has offered precious little material. In fact, the OPDP's missives could be counted on 10 fingers in 2014.

Yes, the FDA's promotional watchdogs only took issue with pharma's marketing efforts 10 times last year. That's half as often as in 2007, last decade's low point, when 19 letters or violation notices went out. And compared with the late 1990s, it's not even one-tenth. In 1998, for instance, the OPDP's predecessor--the Division of Drug Marketing and Advertising Communications, or DDMAC--dispatched 156 disciplinary statements.

Eye on FDA asks whether this means pharma companies have grown very, very good at coloring inside the lines--or whether OPDP simply isn't looking very hard. We'll let you hazard a guess at which.

Consider this, in any case. From 2009, the FDA handed down a series of letters about social media violations, each parsed by marketing experts as if they were ancient writ. Along the way, commentators complained about the lack of official social media guidance--and the FDA regulating by warning letter.

In 2014, the FDA finally issued some social media guidance, skimpy and disappointing as it was. The agency hosted a social media webinar to discuss that guidance; it ran into technical difficulties.

The FDA also sent a social media-related untitled letter to Akrimax about the drugmaker's Facebook page for the thyroid drug Tirosint. That letter happened to be the agency's simplest, clearest communication about Facebook to date. The fact that Akrimax's violation was an old school risk omission? Beside the point.

More to the point was an OPDP letter to Gilead Sciences ($GILD) about some Google AdWords activity promoting the hepatitis B treatment Viread. FDA chastised Gilead for leaving out risk information, failing to mention the drug's generic name, and so on--despite the limited space involved in the venue.

Was that letter easier to grasp than the FDA's guidance on space-constrained communications? At the time, some said yes. In fact, Medical Marketing & Media called Gilead's mishap a precise illustration of what not to do when working under the FDA's new social media guidelines. So was last year's dearth of material a good thing for pharma marketers? Or not?

- read the Eye on FDA blog post
- check out the FDA's 2014 list of OPDP letters

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