Upfront Author’s Note: This is the first posting in a while as I have been working to migrate the subscription service to a new provider. As such, some subscribers were lost in the process. Anyone who signed up for a subscription prior to 2019, would need to sign up again. Apologies for the inconvenience and thanks for your patience.
Years ago, a single regulatory action letter issued by FDA’s Office of Prescription Drug Promotion (OPDP) would not have merited a blog posting in and of itself. That is because OPDP used to issue scores of letters each year. In the last several years, however, FDA’s enforcement arm has issued only a few letters each year. Yesterday they posted a new one and as such, it merits some discussion.
Let’s talk first about though enforcement patterns. There have been a total of 4 letters issued this year by OPDP, two of which were Untitled Letters and two of which have been Warning Letters. It might also be noted that this year the four letters involved five different communications vehicles, two of which were Banner Ads (the subject matter of the most recent letter).
Long time readers will know that enforcement by OPDP dropped off significantly beginning several years ago. There has been lots of speculation as to why and many theories. But in 2018 there was some definitive output from Dr. Janet Woodcock, then head of the Center for Drug Evaluation and Research (CDER) which houses OPDP. In one article she was quoted as saying that First Amendment issues curtailed enforcement activity. In the same article, however, she was quoted as saying that the agency would rather let companies sort it out among themselves rather than involve the agency in comparative claims.
Yet that is exactly what seems to have happened with the newest action from FDA. The letter from OPDP to Amgen took issue with statements made in a banner ad which compared delivery systems for Neulasta which the agency said created an impression of a higher risk associated with one over another. While a study was referenced in the sponsored communication, the agency did not find that the relied upon research was adequate to support a claim of greater safety for one delivery system over another due to the limitations of the cited study. The only violation cited in this Untitled Letter was in relation to this claim. So contrary to the earlier indication from FDA, the agency is getting involved in a comparative claim, perhaps because this claim was in regard to an implication of safety over one of efficacy.
In any case, Dr. Woodcock has since moved on (up) the ladder as Acting FDA Commissioner and OPDP has a new acting lead. FDA’s OPDP certainly has held its powder in the recent past when it comes to enforcement and we will have to wait and see if this newest letter is an indication that there is change coming.
Finally, for those who watch this space, FDA took a simple listing of the regulatory action letters issued by OPDP and made it extremely complicated. One used to be able to look at Warning and Untitled letters in one combined list, but no more. You now can view Untitled Letters by year here. To see the Warning letters issued by OPDP during that same year, you must navigate to a different page and perform a sort on “Office of Prescription Drugs” to narrow the list to only those letters issued by that office. But if you don’t want to do all that, don’t worry, I will do it for you and have created a tab (located in the black bar at the top of the posting and underneath the lead logo banner) on the blog site that lists the letters with links to the letters issued so far the year. This list will continue from here on out.