Today I learned, thanks to a leaked email from Vinay Prasad to his staff, I also learned that Prasad puts a double space after each period which is inexcusable in 2025 when we all use variable fonts on our electronic devices, not a fixed width-font typewriter. Whatever his high school typing teacher told him, he should drop the habit.that FDA’s CBER does actual bench research. This is pure stupidity on my part, as it is right there in the name: Center for Biologics Evaluation and Research. Silly me. They have a page dedicated to describing the work of their 65 principal investigators, and it seems to be at least on par in topics and rigor to the work done at the NIH Intramural Research Program though the latter if of course bigger.
Prasad’s email boils down to this: CBER research staff has strayed from its mission, which is primarily regulatory. We will look at work performed and planned and cut that which is not in line with the mission. He invokes sunken cost fallacy by name, so one would assume work in progress will also be cut, maybe even things completed that haven’t yet been written up — why spend hours formatting a manuscript when you could be reviewing IND Investigational New Drug applications and BLAs Biologics License Application, and let me use this sidebar to note how infuriating it is that one acronym includes the word “application” in it and the other doesn’t, forcing one to resort to clumsy phrases such as the one to the left. I supposed you could write “BLAs and IND applications” but that is listing them out of sequence. instead? And we certainly shouldn’t abuse the privilege of conducting research without having to apply for grants by just padding our CVs with insignificant work that will never be cited, which is another thing Prasad rises against.
My initial reaction was “damn right” but then I realized that regulatory review is just another price scientists-at-heart pay in order to do the work they want, similar to teaching in academia and low pay with no opportunity for outside activities at the NIH IRP. I suppose that eliminating the opportunity for self-directed research — which is what Prasad proposes instead of, let’s say, cutting it down to 10–20% of one’s time — would select for a certain type of a person (I imagine a box-checking blankface) but is that what we want? Is that what Prasad wants?
The tedious and unappreciated work of regulatory review is the price some scientists are willing to pay in order to perform research. Giving scientists the opportunity to do the work that’s meaningful to them is the price the FDA may have to pay to get good people to perform regulatory review. Any important scientific contributions that arise from this concession should be seen as an unexpected gift, not a requirement for staying employed as a reviewer.