Tuesday, February 16, 2021

FDA Publishes Position Paper on Regulation, COVID, in NEJM

FDA has regularly been using forums like Health Affairs and NEJM to share its positioning on diagnostics regulation, especially under the umbrella of COVID.   On February 13, 2021, they posted an article on FDA regulation of COVID serology, but with numerous side comments reflecting goals of FDA leadership for national diagnostics policy.


On September 2, 2020, I published a blog on recent announcements from FDA (August 18) and HHS (August 19) offering conflicting views on the FDA regulation of diagnostics.  That September 2 blog is updated, to include a September 9 FDA article in NEJM, and a September 15 backstory in Politico.


On February 13, 2021, FDA's Jeff Shuren (head, devices) and Tim Stenzel (head, diagnostics) offer an NEJM op ed focused on the year's history of FDA regulation of COVID serology.  Here.  (Update: Paginated at 384:592-4, here.)    I would argue it's not just about "COVID serology," however, as the Op Ed has a range of opinions and goals about how diagnostics should be regulated and "lessons learned" the FDA intends to apply moving forward.   For example, there is a lot of emphasis on national planning and central coordination, something the Trump administration had been repeatedly criticized about.   My reading is that the FDA team is saying, if you want more national planning and coordination, we're here and ready to roll.