1/ This is so bizarre
Closing the barn door 6 months after the horse left the barn, and 3 months after she moved to a different barn!
Trump administration bars FDA from regulating some laboratory tests, including for coronavirus
Let's review-
washingtonpost.com/health/2020/08…
Closing the barn door 6 months after the horse left the barn, and 3 months after she moved to a different barn!
Trump administration bars FDA from regulating some laboratory tests, including for coronavirus
Let's review-
washingtonpost.com/health/2020/08…
2/ Like food, regulation of lab testing is complicated, but to simplify: if you want to package it up and sell it as a product you need FDA approval; if the tests are being done in-house, then it's "CLIA" - mostly CMS (w FDA and CDC).
But what about a public health emergency?
But what about a public health emergency?
3/ In a public health emergency, you might want to allow people to try unproven treatments, or diagnostic tests, but with some oversight. That falls under "emergency use authorizations" of the FDA.
Lab-developed tests (remember normally under CMS/CLIA) would also be included
Lab-developed tests (remember normally under CMS/CLIA) would also be included
4/ So you can have...and we DID have... a problem where- unless FDA Is REALLY QUICK with issuing these EUAs to labs, you can actually slow down expansion of lab capacity in an emergency.
This complicated interplay of regs was apparently a surprise to "HHS officials"...
This complicated interplay of regs was apparently a surprise to "HHS officials"...
5/ Um... except that the previous FDA chief painstakingly laid it all out in a secret 10-part document on the internet
ON THE SECOND DAY OF FEBRUARY
ON THE SECOND DAY OF FEBRUARY
6/ OK, we can't all be as smart as @ScottGottliebMD but we could maybe expect our policymakers to rely on experts.
We wasted WEEKS in a critical phase of the outbreak, overly reliant on the flawed CDC tests, but by March the EUAs were rolling out finally
We wasted WEEKS in a critical phase of the outbreak, overly reliant on the flawed CDC tests, but by March the EUAs were rolling out finally
7/ By May, FDA had issued a new policy making it pretty darn easy for new lab-developed tests to get the EUAs.
In fact, they have had to revoke some EUAs when we learned the tests didn't perform well, with lots of false positives or false negatives
That's why you need oversight
In fact, they have had to revoke some EUAs when we learned the tests didn't perform well, with lots of false positives or false negatives
That's why you need oversight
8/ So NOW we are notified that @HHSGov believes FDA doesn't have the authority to require EUAs
the department has determined that the Food and Drug Administration ("FDA") will not require premarket review of laboratory developed tests ("LDT") absent notice-and-comment rulemaking
the department has determined that the Food and Drug Administration ("FDA") will not require premarket review of laboratory developed tests ("LDT") absent notice-and-comment rulemaking
9/ Six months after the problem. Three months after there is explicit FDA policy fixing the problem.
@scottjbecker CEO of Public Health Lab Assoc (@APHL) nails it. “I’m not certain why this reversal by HHS was done now, given the oversight process seemed to be working”
Bizarre
@scottjbecker CEO of Public Health Lab Assoc (@APHL) nails it. “I’m not certain why this reversal by HHS was done now, given the oversight process seemed to be working”
Bizarre
10/ Lessons from this
*Expertise Matters (listen to people like @ScottGottliebMD)
*Regulatory oversight sucks, lack of regulatory oversight sucks more
*One day we need to re-architect the patchwork oversight of labs (and food, and animal disease)- but thoughtfully, not like this
*Expertise Matters (listen to people like @ScottGottliebMD)
*Regulatory oversight sucks, lack of regulatory oversight sucks more
*One day we need to re-architect the patchwork oversight of labs (and food, and animal disease)- but thoughtfully, not like this
