This is sort of a two-for posting. First we will look at a change in how FDA is reporting regulatory actions by OPDP on the FDA website, and second we will cover the most recent such action.
OPDP Warning Letter Change. Not as compelling perhaps as Harry and Meghan splitting from Buckingham Palace, but there has been a split at FDA’s OPDP between Warning and Untitled letters. For anyone tracking enforcement, take note. It just got a little more difficult.
As an agency, FDA issues Warning Letters from multiple sources covering a span of topics and concentrated on various segments of the subject matter jurisdiction of the agency – from food to devices to cosmetics and of course, to the communication by the manufacturers of medicine about their products.
When it comes to the Office of Prescription Drug Promotion (OPDP), the regulatory actions that came from that source were up until now all stored on a single page within the OPDP portion of the FDA website listing the letters in chronological order and making distinct which ones were Warning Letters and which ones were Untitled Letters. No more.
For reasons indiscernible to this author, the agency recently split Warning Letters from Untitled Letters and now displays them in separate parts of the FDA site. Untitled Letters are still located on the OPDP site, but the Warning Letters have been moved to a portion of the FDA website where all agency-wide warning letters are being housed – no matter from where they originated. To find those specific to OPDP you must now (inconveniently) conduct a search.
That sounds easy enough, though it deprives you of the former chronological view of what OPDP is doing by way of enforcement. You will have to put the two groups into your own chronology. Not a big deal, but it adds a step. However, the way the new page/search function has been set up may also lead to some confusion. There is a drop down menu that includes all of the various points of origin for a Warning Letter within FDA. When looking for letters from OPDP the drop down menu includes the option to search for Warning Letters from either “Office of Prescription Drug Promotion” or “The Office of Prescription Drug Promotion”. But if you happen to search under both, you will get different results. When you select the tab for “The Office of Prescription Drug Promotion“, you will see the two letters issued and posted this year. When you select the tab for “Office of Prescription Drug Promotion” you get a different result that lists two additional Warning Letters posted in 2021, but which were sent in 2017.
This is hopefully a bug to be worked out over time, but the separation of Warning and Untitled nevertheless will likely stand. Hopefully FDA will sort out the different results for different tabs for the same office. Ultimately not a huge deal, just inconvenient.
However, perhaps most importantly, the search tool for Warning Letters does not go past 2017 and there is no link from the search page to the archives. So it is unclear whether or not one can access letters prior to that year when using this new page. In fact, if you visit yet another page, you can find a link to the archives, even though there is no direction in relation to that on the Warning Letters search page. This is on a page entitled “Warning Letters and Notice of Violation Letters to Pharmaceutical Companies” even though this page only actually contains links/tabs to Untitled Letters. When you go to the Archives, the tabs are all labeled “Warning Letters” but in fact, if you click on them, you go to archives that contain both Warning Letters and Untitled Letters. All in all this is a rather confusing reconfiguration.
OPDP Issues First Untitled Letter of the Year. With two Warning Letters having already been issued this year, OPDP has issued its first Untitled Letter of the year, with two of the three regulatory actions so far this year being attributed to the “Bad Ad” program. Remarkably, this is the second letter to be issued by OPDP involving a Kardashian. Go figure – though also remarkably – it involves a second Kardashian. The subject matter was a DTC video. While there are many takeaways from this letter, here are a few of the highlights:
- A point I have always made when conducting a training related to promotional communications is that the use of a spokesperson is one of the riskier tactics one can undertake. That is because personal experience with a medication is highly subjective – the “what it did for me” factor, which is not always in lock step with what was found in the clinical trials. That is what happened here – a statement made that “[i]t literally works within, for me, 15 minutes…” was different from the clinical studies of the drug which was closer to two hours for expected relief. A statement included in the video that “results may vary” was considered insufficient by OPDP to mitigate what they considered to be a misleading statement;
- Further use of language referring to the medicine as a “game changer” and comparing it to other medicines sets up a superiority claim;
- Finally the presentation of risk information in the context of relating a personal experience with a medication can be challenging and here the information appeared briefly in text format at the end of the video where the agency felt it was unlikely to draw viewer attention.
That is the third regulatory action by OPDP three months into the year. If that keeps up, 2021 should be a much more active year than those in recent memory. Even if we have to hunt and pick to find them all.