It is time to look back at enforcement for the 2019 year. It is still possible that FDA could post another letter, as there is a lag time between the time a letter is sent and the time it is posted to the web site, but let’s hope the Office of Prescription Drug Promotion (OPDP) did not send one out as a holiday greeting.
Comparing this year to other recent years, the enforcement actions taken by OPDP was not as sluggish as it has been, but neither was it robust. Long gone are the kinds of years where the agency would issue well over 100 enforcement letters for each and every violation that appeared. Instead now, the agency appears to have areas of concentration where enforcement is focused.
During 2019, as of this writing FDA issued a total of 10 enforcement letters, addressing communications carried in 11 different communications vehicles. While interesting warning letters went out from FDA outside of OPDP – for products containing CBD, for example, our focus is solely on promotional communications. Here are the highlights from this year:
- Communications Vehicles – Violations were just about evenly divided between digital communications vehicles and traditional ones. On the digital side, there were 5 violations – the most frequent communications cited involved statements made on a website (4), and one letter sent regarding an email. On the traditional side of communications, there were a total of 6 – almost all DTC videos (4)- one of a DTC video involving a patient testimonial – one of the riskiest areas in promotional communications to my thinking. (I categorize DTC video in the traditional category rather than digital). On the traditional side there was also a banner ad and a print DTC ad involved in enforcement.
- Treatment Area – No single treatment area dominated enforcement. In the broad category of CNS-related treatments, there were two violations, two in oncology, two in erectile dysfunction. In short, there was nothing to indicate that the agency is focused on a treatment area with enforcement.
- Companies – Small companies watch out. The trend continues for OPDP to aim its enforcement mostly at companies that are generally not considered household names in the industry. This year was almost no different with the notable exception of the inclusion of Alkermes (more on that below). It is unclear whether large established companies have gotten highly adept over the years at scrubbing their communications to the point that they are more compliant with regulations or if FDA is finding that smaller companies provide good examples of violations the agency is concerned about.
- Warning versus Untitled Breakdown – Untitled Letters – also referred to as Notice of Violation (NOV) letters are considered the less serious of the two categories of regulatory action letters sent by OPDP, while Warning Letters are reserved for those violations FDA regards as more serious. This year, three out of the ten letters issued were Warning Letters. That is on par with a look at the cumulative rate over the years – in my database going back to 2004 that profiles over 330 letters from OPDP, about one in three letters are Warning Letters. So the proportion did not change this year. So even though FDA seems to be reserving its regulatory actions for violations it deems most noteworthy, that does not appear to alter the traditional approach to Warning Letters.
- Violations and Focus – There were 21 violations cited in the 10 letters issued this year. As per usual, by far and away, the most common violation cited by FDA is one that you would think might be the easiest area for compliance – the inclusion of risk information. This involved nine violations – nearly every letter issued by the agency this year. The other violations were for making a superiority claim (3), unsubstantiated claim (3), unapproved use (1) and promotion of an unapproved drug (2). That last one is noteworthy. While promotion of an unapproved drug was numerically low, it is proportionally high. Historically promotion of an unapproved drug has been an rather uncommon violation, having occurred only 19 times by my count since 2004, but 14 of them have been since 2012 and 11 since 2015, indicating it is a high area of interest for the agency in recent years. So the bottom line – there are two things to watch for in communications – risk information and pre-approval communications – particularly if you are a small-ish company.
Finally, one thing that occurred this year that was highly unusual with respect to enforcement concerning the final letter of the year issued by OPDP on December 2. FDA accompanied the posting of the letter – a Warning Letter – to the website with the issuance of a press release about the letter. That is highly unusual and in fact, I do not recall an instance where the agency brought so much attention to an enforcement action since April 2009 when OPDP (then called DDMAC) issued its misguided set of 14 letters impacting 45 brands. It does no good to second-guess reasoning, but it bears noting that his particular letter involved a drug utilized in an area where all stakeholders, including FDA, have been under scrutiny – opioids. The communications about the medication was lacking important risk information, FDA found. While risk information is obviously an important area of focus in enforcement, it is perhaps even more so for those manufacturers who are operating in the area of pain relief.