Friday, June 28, 2024

Policy Watcher Again: New SCOTUS Cases Continue to Support ACLA v FDA Case

UPDATE: Sen. Cassidy writes the FDA, says Chevron ruling should call into question the FDA's LDT land grab.  Here.


 A few days ago, I wrote a blog that as a long-time policywatcher - not an attorney - I felt several recent Supreme Court cases were supportive of the ACLA's case against FDA.  See June 21 blog here.

For June 28, I've added an update.

I would suggest that the court's anti-Chevron ruling in Loper v Raimond also supports ACLA v FDA.   Loper finds that courts are not obligated to defer to an agency when a statute is ambiguous.  Rather, a court should review the statute in question de novo.   

Here, that would mean a court does not any longer need to defer to FDA whether the 1976 intention of Congress was for [a laboratory of people and items conducting processes] to be collectively commonly and normally understood to be "a medical device.”  For example, according to 1976 dictionaries or usage at the time.


A new subscription article at 360DX, by Adam Bonislawsky, triages the opinions of several attorneys re the ACLA legal case.


The presidential election could also be a factor.


WSJ notes FDA LDT is one of the policies now in play because of the Anti-Chevron decision - here.