As reported earlier this year, the volume of regulatory action letters flowing from FDA's DDMAC continued to increase during the first half of the year at a rate that, if the trend continues, would see between 70-80 letters for the year – a substantial increase over recent years.
But what about the substance of those letters? The numbers certainly tell us one aspect of the story – that enforcement is up, but it doesn't tell us what tripwires have been most commonly crossed.
Let's take a look. During the first half of the year, there were 41 letters issued citing, by my count, 108 different violations. What is tripping people up?
It appears that one of the most common mistakes would actually be one of the easiest to avoid – the inclusion of risk information in a communication. Granted, there are times, where the placement of risk information may seem reasonable to any reasonable person looking at a particular communication, but where in the FDA's mind it is not (e.g., the so-called "one-click rule").
Assessing the many risk information lapses, one can see that the agency is very particular and is stressing that risk information cannot in any way be an effort to discover on the part of the audience. I would say that the rules of thumb here are – risk information cannot be in smaller type, it cannot be in duller colors, you should not have to scroll down a screen to find it and of course, you cannot have it a click away. It cannot be stuck at the end of a video like movie credits.
The vehicles for these violations were multiple and though there is a great deal of trepidation among regulatory and legal reviewers in companies about the Internet, in fact, most of the violations are carried by printed word or broadcast, not by the Internet. In fact, only 6 of the violations occurred involving a Web page, while the bulk were in DTC print ads, brochures, a waiting room sign, journal ads and the generic "sales aid". One even occurred in the text of an email and one violation involved the spoken word.
The two most unusual letters of the first two quarters involved cases of first impression. The first was an NOV letter sent not to the sponsoring company, but to an individual physician who had served as a clinical investigator for a product and during media interviews characterized the product as "lasting longer and kick in faster" than existing approved products. The agency interpreted these representations as promotion of an unapproved product as safe and efficacious.
Later in the year, we saw the first letter issued to a company involving social media – specifically Facebook. This has been well described by Wendy Blackburn in a post to the blog ePharmaRX. Here the FDA issued an NOV letter respecting the Facebook "share" function which allows for a user to share information because indication could be carried without the "balanced" appearance of risk information. Unfortunately it is an example of how DDMAC is focusing on the micro aspects of social media without having addressed the macro.
But together with the violations that were racked up related to omission/minimization of risk information, it spells out the FDA preference when it comes to risk information. The information must always be present and must always be visible and apparent. In addition, it appears the agency is really examining closely the totality of the communications vehicle more than the parts, and assessing the impression that the audience will have when looking at it, meaning that those seeking to communicate medical product information should do the same.
It should also be noted that among the 41 letters, nearly one-fourth (9) of them were Warning letters as opposed to NOV letters. They primarily were targeting smaller, more inexperienced companies, though in a few instances, the companies that got them were well-established. The number, however, is high when you consider that only a few years ago, the agency didn't issue more than 25 of all types of letter in an entire year.
Clearly enforcement is up and the agency has signaled this not only with the increased issuance of letters, but with the launch of its "Bad Ad" program which seeks to deputize doctors into DDMAC enforcers. Communicators should take note.
Mark excellent round-up, thank you. One thing I can add: In many of the 2010 letters, DDMAC reiterates that patient-facing pieces must use “consumer-friendly language” rather than “complex medical terminology” to describe risks. DDMAC seems to be championing the principles of health literacy and reminding regulated marketers that the needs of the audience matter. This is a shift and will take some getting used to, especially at manufacturers with less patient marketing experience.