The Prophecy: How will the FDA under the New Trump Administration Handle OPDP Letters? (Jeff and Dara’s Version)

We recently saw an interesting Instagram post aimed at Swifties disappointed in the election results.  It noted that Tay Tay released four albums during the first Trump administration and only two during the Biden administration, so there’s reason to hope for the next four years if one was despondent over the election.  (One of the undersigned is an avowed metalhead and cannot attest to the accuracy of the statement because he was too lazy to ask his teenaged daughter.).

It got us thinking (dare we saying, having a prophecy?), how would the second Trump administration compare to the Biden administration when it comes to FDA OPDP warning letters and untitled letters for promotional issues?  Our assumption was that using the first Trump administration as a baseline compared to the Biden administration would result in an inverse correlation to the above mentioned Taylor Swift output.  (Thus proving that anything can be made to sound more intelligent when saying “inverse correlation” including a comparison of Taylor Swift albums and FDA letters.)

Much like Ms. Swift, we did something bad in assuming this.  Like most of  Taylor’s dating choices, we were completely wrong.  In fact, the number of letters issued by OPDP (both Warning Letters and Untitled Letters) were almost identical under the first Trump administration and the Biden administration to date.  Under the first Trump administration, FDA issued 16 untitled letters and seven warning letters (almost, but not quite 22).  Under the Biden administration, the numbers were 15 untitled letters and 4 warning letters.

So what does that mean going forward?  We’d like to say that the past is perhaps predictive of the future, but given the potential involvement of Trump whisperers like RFK Jr, who is no fan of Big Pharma (or perhaps any Pharma), we simply don’t know.  While certain aspects of business regulation and other areas of FDA regulatory oversight are likely going to be loosened up under the new administration, companies should remain vigilant about their promotional review processes and should not assume that everything has changed.  We know all too well how delicate this would be treated if this was a movie — all we can say is breathe, we may need to tolerate it but ask, are you ready for it?