The Dysfunctional FDA
A front-page article in Wednesday’s print edition of the Wall Street Journal is titled “Three Lost Weeks Stalled Virus Testing.” (The title in the linked e-version is slightly different.) The reporters are Stephanie Armour, Brianna Abbott, Thomas M. Burton, and Betsy McKay. The investigative report is quite good.
It talks about a number of mistakes made up front by the CDC. But here’s a whopper about the FDA:
Complicating matters for commercial and hospital labs, a public-health emergency Mr. Azar declared Jan. 31 created a new regulatory hurdle: They would soon have to seek emergency-use authorization from the FDA, a potentially time-consuming process, before their tests could be used. In a nonemergency, hospital and academic labs are typically allowed to design and implement their own in-house tests without much regulatory oversight. The FDA spokeswoman said that, in many cases, the FDA can do this review in as little as a day.
Get that? If there’s not an emergency, commercial and hospital labs are allowed to use their own tests. But if there is an emergency, these labs must seek and get FDA authorization.
I do not think that word “emergency” means what the FDA thinks it means.