Air Date – SEPTEMBER 25, 1:00 PM ET
The US Supreme Court’s recent decision in Loper Bright Enterprises v. Raimondo weakened the FDA’s position that it has the authority to regulate laboratory developed tests (LDTs) as devices. Loper Bright overturned the Chevron doctrine, which had required courts to defer to federal agencies’ interpretations of ambiguous statutes. Courts must now exercise independent judgment in deciding whether an agency has acted within its authority.
Loper Bright has a direct impact on the pending lawsuit against the FDA by the American Clinical Laboratory Association (ACLA), which challenges the agency’s authority to issue and enforce the LDT final rule. The decision also serves as a basis for congressional inquiries into the FDA’s authority, and will likely influence new legislation that promises to create less burdensome regulations for laboratories.
This webinar will explain the Loper Bright decision and the potential effect on regulation, legislation, and lower court decisions that impact laboratories.