Friday, March 8, 2024

In Writing: My Prediction for FDA LDT, 2024-2031

 It was big news in the past week that FDA has sents its final LDT rule to the White House for final sign-off and publication.

I'm putting my official multi year policy forecast in writing.  Here.  Click to enlarge.

click to enlarge


First, for simplicity, I'm leaving the initial FDA timelines as published in Fall 2023, but I think it is very likely (80%) then will all advance by one year.  Regardless, the court case will start immediately.

Second, I think there is a 95% (really, 100%) chance this will tie up in court for several years.   Allow 2024 for federal court, 2025 for appeals court, and 2026 if not easily 2027 for Supreme Court.

Third, at Supreme Court, while I am not an attorney, I give a 50% chance the regulation will be tossed out as agency overreach and lack of clear Congressional text governing LDTs.   I give a 10% chance that in 2026 or 2027, it will undergo further legal circling like being remanded to a lower court.  

This leaves a 40% chance of the regulation being turned back on and its engine revved in 2027 or so.

Fourth, I predict, as in my initial white paper in October 2023, that the rule will have to bog down in several years of delays and deferrals if not worse.   By 2029 or 2030 this will lead people to dust off VALID or other alternatives.



Other possibilties include a 2nd Trump administration that might reverse the rule in a 90-day rulemaking (or un-rulemaking) cycle.  Or might (more subtly) just decline to defend it assertively in the courts, raising the chance the FDA reg loses in court.