UCLA OPDP Letter

In its latest action letter, which came in under the wire for 2017 as it was issued on Dec. 28th, OPDP cited the University of California at Los Angeles (UCLA) for its promotional claims about an unapproved drug, a radioactive imaging agent, Ga68-PMSA, used in positron emission tomography (PET).   Promotion of unapproved drugs as a specific cause for an OPDP action are relatively rare and a quick search by me could come up with less than 30 letters since 2000, with the vast majority of those to pharmaceutical companies.   In fact, this letter represents only the 2nd letter I could find in that period sent directly to a university for promoting an unapproved drug.  The other letter went to UCLA, as well, a couple of years ago (2015).

OPDP cited UCLA in its 2017 letter for a number of promotional claims about Ga68-PMSA, saying that those claims fall outside of what is allowed for discussing unapproved drugs, i.e., dissemination of scientific information.   Looking at the claims and materials OPDP cited, it appears that OPDP is correct.

As background, there are many recent literature reports about the promise of Ga-68 radiopharmaceuticals for medical imaging.   The results of scientific studies for Ga-68 PMSA are very promising.  However, it is the use and, more accurately, the summation of the results of that scientific data to promote a patient to ask to have this scan or HCP to suggest this scan that is no doubt concerning to OPDP, considering that there is no FDA approved version of this drug.

I think the fact that this came from a university-related medical center is interesting and the fact that it follows on the 2015 letter to UCLA for promoting [F-18] FDDNP, another unapproved PET imaging agent is also of note.

So, what is to be learned from this letter?

What I am about to say is my opinion and, in no way, is meant to say that UCLA did anything malicious.   However, in my experience, scientists not trained in the rules of promoting pharmaceuticals usually don't understand the difference between just giving information to people and active promotion of an unapproved drug.  As I was a drug discovery scientist at a pharmaceutical company before moving to Regulatory Affairs, I get it.  What scientists may consider a fact based on available data is, to OPDP, an unsubstantiated claim if the drug under discussion is not FDA approved.  Scientists don't normally understand that even though a drug may look good in a limited study, it could have risk-benefit limitations that might make it not approvable by FDA or that there may need to be some significant restrictions in use if the drug is approved.   They don't understand that those determinations can only be made after looking at larger studies and all the associated data (e.g., manufacturing) that goes into making sure a drug is safe and effective for human use.  This is not meant as a slam against scientists, it's just my experience as a former scientist and a regulatory person who deals with these scientists in a promotional setting.

This letter and the previous letter to UCLA point out the need for good Regulatory advertising and promotion training for universities and medical centers that are using unapproved drugs.  It also would be helpful if the content of outwardly-facing materials (e.g., websites and brochures) underwent review by someone experienced in OPDP regulations.    Finally, it should refresh for pharmaceutical companies the necessity to have good oversight with the universities that are conducting their clinical trials and the materials those institutions are using to recruit patients.