THREAD: For the last 6 months, FDA’s device center worked effectively with labs to advance hundreds of tests for Covid. A new HHS policy that extricates FDA from this work - and goes further, by removing any FDA role over any lab developed test - could put this work at risk. 1/x
At issue are lab developed tests. For a time, there was debate what FDA’s role was over these LDTs. It was long settled that LDTs were medical devices, subject to FDA oversight. For the vast majority of LDTs, FDA exercised enforcement discretion, and didn’t actively regulate 2/x
This FDA authority was articulated in countless guidances, enforcement actions, testimony. It was the subject of 2006 guidance that was cleared by HHS under Bush. Bipartisan legislation now moving through Congress would further codify the contours of this general framework. 3/x
But for a subset of LDTs that pose greater risk to patients, where precision and reliability is medically critical, FDA requires pre-market review. This included tests used to screen for pathogens in a public health emergency. This is long established public health precedent. 4/x
Early in Covid, it was made clear that once a public health emergency was declared, it created a Catch-22 for LDTs. Normally they'd come to market without prior FDA review. But with the PHE declared, LDTs that screened for it required FDA permission. 5/x
It was critical to allow labs to move tests forward quickly, to fill testing shortages. A well crafted policy enabling an efficient path for Covid LDTs to come to the market and seek FDA’s clearance later was finally released by HHS on February 29th 6/x
In the intervening time, FDA has worked with labs to advance countless testing innovations under FDA’s Emergency Use Authorization (EUA) authority. To date, FDA has authorized 218 tests under EUAs; including 176 molecular tests for coronavirus, and 3 antigen tests. 7/x
Under this process FDA provides feedback to test makers. Countless labs say FDA counsel helped improve test quality. The process was efficient; FDA’s staff is highly responsive. On the flipside, there are issues with the quality of some tests. FDA’s oversight role is critical 8/x
Now, FDA’s ability to protect public health could be challenged. FDA might not be able to provide critical advice to test developers or take needed enforcement actions against bad tests. After all, how can FDA take action over something HHS says it doesn't regulate? 9/x
We'll see a plethora of DTC Covid tests enter the market, where tests ship directly to consumers and are processed in a central lab operating outside FDA oversight. CMS oversees lab operations, but there’s no process for ensuring clinical accuracy prior to coming to market 10/x
The new policy is broader than Covid. It covers any LDT. Sweeping medical device policy was advanced in the context of a public health crisis. It isn’t the right time, or place, to consider these issues. Congress was actively weighing it and advancing bipartisan legislation 11/x
The process was mostly working. New tests were entering the market; innovation unfolding. Now all LDTs authorized under EUA could be in limbo. How can FDA grant EUA for something it has no authority to require? Liability protections that attach with EUAs may be inoperable 12/x
There will be a time and place to consider the right framework for pandemic response. Congress will have to act, including when it comes to LDTs. Policies issued in the middle of this pandemic should be carefully considered for their impact on the crisis. First do no harm. 13/x
