Wednesday, September 2, 2020

The Dueling FDA and HHS Announcements about EUA, LDT: August 18, August 19

Update: This article discusses dueling announcements/publications from FDA and HHS around August 18 and 19.

On September 9, Jeff Shuren also published an article in NEJM on the importance of the FDA in regulating COVID testing (here).   And on September 15, Politico gave a corresponding story, that in August, HHS (Azar) had directly overruled opinion leaders inside FDA including the administrator (short story here; Politico Pro may have run a longer story too).

You can imagine this fits a larger story - that FDA leaders were dismayed at being muzzled and overruled by HHS; but at the same time, no one could stop the FDA leaders from publishing articles in their favor at places like NEJM and Health Affairs.


Original September 2 blog:

Some sources discussing the HHS announcement on August 19 (that FDA can't mandate review of LDTs including COVID LDTs), must have referred to the FDA article on this topic the day prior, August 18.  But it's new to me.

On August 18, 2020, FDA leadership - Anand Shah, Jeff Shuren, Stephen Hahn - published an article in Health Affairs about the FDA's success and role in controlling access to COVID testing through the EUA process.   Article here.   

On the next day, August 19, 2020, Health and Human Services issued a public announcement that FDA was now blocked from enforcing regulatory management on lab developed tests, LDTs.   Announcement here.   Some analysis of the HHS document here and here.

I'm closing with a screen shot - 

August 18 (FDA), August 19 (HHS)