On Jun 28, 2024, SCOTUS overturned the Chevron doctrine, which means that courts will no longer automatically defer to agency expertise when interpreting ambiguous laws. This ruling has significant implications for the Chevron doctrine, a legal precedent that has guided how courts defer to federal agencies' interpretations of ambiguous statutes for nearly 40 years.
The ruling transfers more interpretive power from federal agencies to the judiciary. Courts will now have greater authority to independently interpret statutes without necessarily deferring to agencies like the FDA. The agency will face increased scrutiny and potential challenges to its regulatory actions. This change will likely lead to a litigation surge as courts and litigants test the boundaries of this new judicial authority.
How will this impact the LDT rule? It was highly anticipated by the LDT industry and the agency that the LDT rule would be challenged in courts. The American Clinical Laboratory Association (ACLA) filed a lawsuit against the FDA in response to the agency's final rule issued on May 6, 2024, which aims to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This legal action, filed in the U.S. District Court for the Eastern District of Texas, argues that the FDA's rule overreaches its authority and misclassifies professional laboratory testing services.
The Chevron ruling means that courts will not automatically defer to federal agencies for interpretation. The LDT regulations essentially define IVDs as devices under the FD&C Act when the manufacturer is a laboratory. The agency appears to have been very careful in establishing the regulations in anticipation of legal challenges. The agency has also accumulated data over several years to support its position. Courts will now decide if they agree with the FDA that IVDs are devices under the FD&C Act if the manufacturer is a laboratory. It is also possible that courts may defer to the legislative branch to pass the VALID (Verifying Accurate Leading-edge IVCT Development) Act or similar legislation. Regardless of the outcome, we will likely see more litigation and challenges.
