UPDATE: Sen. Cassidy writes the FDA, says Chevron ruling should call into question the FDA's LDT land grab. Here.
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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.
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A new subscription article at 360DX, by Adam Bonislawsky, triages the opinions of several attorneys re the ACLA legal case.
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The presidential election could also be a factor.
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WSJ notes FDA LDT is one of the policies now in play because of the Anti-Chevron decision - here.
