The Chevron Deference standard was a 40-year-old Administrative Law benchmark that gave federal agencies the power to interpret ambiguous laws and issue regulation based on their subject-matter expertise. On June 28, 2024, in a 6-3 ruling in Loper Bright Enterprises v. Raimondo, the U.S. Supreme Court overturned the court’s prior ruling in Chevron v. Natural Resources Defense Council.
In the Loper Bright ruling, the Court concluded that the 1984 Chevron decision was wrongly decided because it was inconsistent with Section 706 of the Administrative Procedure Act (APA), a federal law enacted in 1946. Justice Roberts wrote for the majority that “the APA specifies that courts, not agencies, will decide ‘all relevant questions of law’”. Current thinking is that “[t]here’ll be no area where agencies act to protect the public’s health or safety … that won’t be adversely affected by this ruling.”
So – now that Chevron has been overturned, what will be the immediate impact on the IRB regulatory requirements for submission and approval of clinical studies? The answer is: ABSOLUTELY NONE. There has been NO immediate impact on the FDAs, or other federal agencies, ability to enforce regulations. Similarly, it will take a challenge to a regulation or guidance and a trip through the courts in order to bring about any change in the regulations applied to drug/device/tobacco/etc. approval. However, the Loper Bright ruling may invite lawsuits that will do so in the future.
Though the Loper Bright decision does not immediately, or directly, overturn current human subject protection regulations: impending litigation, and an unfavorable decision on some FDA regulatory action, could bring about formal change.
What other actions, besides the possible impact on IRB regulatory requirements and regulations, should researchers and research oversight professionals expect following this ruling. For example:
- Will FDA release informal guidance more frequently and not risk potential litigation brought about by proposing and finalizing new regulations? If so, IRBs and researchers will need to rely more on guidance.
- Will the threat of litigation affect FDA’s ability to release timely regulations and guidance for new advances in research?
The real-world impact of the Loper Bright ruling remains uncertain. Though the decision does not immediately or directly overturn human subjects research regulations, it invites lawsuits to do so. In brief, the Court’s decision transfers substantial power from subject-matter experts at the appropriate federal agencies to federal judges who may not fully understand the impact of their rulings.