FDA’s Division for Drug Marketing, Advertising and Communications (DDMAC) is responsible for regulating the communications by medical product manufacturers with the public about their products. During 2010, the agency issued 52 letters, which is more than during any year since 2001 when there were 64 sent and a far cry from the peak in 1998 when there were 156 regulatory actions taken by DDMAC.
Still, the upswing indicates a return to higher enforcement levels for the agency and for those who are responsible for such communications, both inside the companies themselves and for those who work with them, it is important to look back to see what the most common triggers for regulatory action have been and why the agency took action.
First off, to anyone who has seen any of the quarterly reports here at Eye on FDA, it will come as no surprise that the most common violation involves risk information, or rather the lack thereof, followed by overstatements of efficacy. The “other column includes a failure to submit material to FDA, promotion of unapproved dosing regiments, omission of indication, omission of a material fact, and failure to provide directions for use or complete information about an indication.
Next we look at the number of Warning Letters versus Notice of Violation letters. For those not familiar, Warning Letters are usually issued where there are numerous violations and where the agency might consider them more likely to have a public health impact. There were 52 letters issued during 2011, meaning that 35% were issued as Warning Letters and 65% were issued as NOVs.
Lastly, let’s examine the communications vehicles that carried the messages deemed violative. As you can see DTC, which includes TV ads and any printed materials intended for patients to read, was by far the vehicle cited most often. That doesn’t mean that it is a riskier means of communication, as it is also probably has the greatest volume associated with it – so it is also a matter of proportion. Websites and sales aids follow in terms of number.
The category of video is interesting because there the pitfall is often repeated again and again where patients are used to describe their experience with a particular medication. It is also noteworthy that, in the continued absence of any guidelines in which to operate, and the increased presence of the medical products industry in social media, there has been to date only one violation involving a social media tool.
On February 7 at the ePharma Summit being held in New York, I will be conducting a half day workshop called “What Can You Say? How Can You Say It? FDA/DDMAC Enforcement Trends” that (being all afternoon long) will delve quite deeply into the substance of the letters that were issued during 2010. What were the most common mistakes, what were the anomalies that teach us lessons? What vehicles spawned what types of violations? What are the observed standards for each type of violation? If you come, please say hi!
And next week, I will highlight some DDMAC lessons learned from 2010.