Navigating the Future: The Supreme Court’s Influence on US Healthcare Regulatory Authority
The US Supreme Court is currently deliberating on three pivotal cases that promise to redefine the landscape of federal regulatory authority in healthcare, particularly affecting the delivery of cancer care. These cases scrutinize the longstanding Chevron deference and the FDA’s drug approval authority, with significant implications for healthcare practitioners, pharmaceuticals, and patient care standards across the nation.
Key Points:
- The Supreme Court is examining three cases (Loper Bright Enterprises v. Raimondo; Relentless, Inc. v. Department of Commerce; Alliance for Hippocratic Medicine et al v. the FDA et al) that could significantly alter the regulatory framework governing healthcare in the US
- Two cases challenge the Chevron deference, which has historically empowered federal agencies with the authority to interpret ambiguous statutes, potentially impacting regulatory bodies like the FDA and CMS.
- The American Cancer Society and other health organizations have expressed support for maintaining Chevron deference to preserve the expertise-based decision-making of federal agencies.
- A decision against Chevron deference could disrupt healthcare delivery, affecting areas like pharmaceuticals, medical devices, and public health insurance programs.
- The Alliance for Hippocratic Medicine case directly challenges the FDA’s authority to approve drugs, focusing on the drug mifepristone, which has broader implications for drug availability and healthcare standards.
- ASCO and other healthcare organizations advocate for upholding the FDA’s drug approval process to ensure patient safety and encourage pharmaceutical innovation.
- Decisions in these cases are anticipated in the summer of 2024 and could have profound implications for healthcare delivery, regulatory authority, and patient outcomes in the US
“ASCO believes the potential implications of this ruling could threaten the regulatory regime that makes medicines safe, reliable, and available to patients and their clinicians.”
More in Business & Policy