Hey! 2009 called. They want their Warning Letter back!
Last week FDA’s Office of Prescription Drug Promotion (OPDP) posted the first letter issued for 2020 that was sent in February for the most common violation of all – related to the minimization or omission of risk information. This evoked shades of April 2009 when the agency issued letters covering 45 brands to 14 companies for banner ads on the Internet. Only a month before OPDP had said that the guiding rule of thumb in regulatory enforcement in digital media was that they were concerned with the “message not the medium”. Then they issued a slew of notice of violation (NOV) letters aimed at a medium.
But the reason for those letters, and this one, was one that was indeed about the message. It lacked risk information on its face and presumably it was offered at the landing site to which the sponsored link took one who clicked on it.
Even though the letter involves and age-old regulatory issue – the inclusion of risk information – and a set of facts we have seen before, there are some things to take away from this particular letter. Not only did the agency take regulatory action on this promotion, but it issued a Warning Letter (WL) rather than a Notice of Violation (NOV) a/k/a Untitled Letter. What are the insights from this action? I have no line into OPDP, but here are a few independent observations:
- First of all, in this instance, the promotional communication was in connection with a product that also has a boxed warning on the label. The presence of a boxed warning indicates a special concern regarding the use of the product that is being emphasized. It is also a surrogate marker for those responsible for promotional communications to take extra special care. In this case, there were safety issues related not only to a potential for abuse (an area of specific concern overall) to the potential for cardiovascular adverse events if misused or used by patients with specific conditions.
- Another factor is that the product is a treatment for ADHD – a treatment category which has had (by my count from my database) 13 letters issued since 2005, 9 of which involved the exclusion or minimization of risk information and 4 of which involved the use of a WL over NOV. If you are responsible for communications for a product, it is not a bad idea to get an idea of the causes of regulatory actions by OPDP in the past – what were the tripwires and lessons to be learned?
- And there is the fact that the advertisement was directed to the use of the product with children. When dealing with a vulnerable population it is important to take extra care in communications to ensure that the potential for a violation is utterly minimized.
- Finally, the letter refers to complaints from the “Bad Ad” program, indicating that this effort of OPDP to deputize health care professionals to be alert and inform FDA of potential violations is still active.
Enforcement has been at a very low rate for a long time, but low enforcement does not mean no enforcement and the agency has said that it is turning its focus to communications which pose a higher level of concern such as risk information lacking for products with a higher level of risk profile and for pre-approval promotion. Every promotional communication requires scrutiny, but when a product has some specific traits – a category that is scrutinized, a vulnerable population and/or a boxed warning – these are characteristics that merit heightened regard.