The Association for Clinical Oncology (ASCO) is closely following three cases before the United States (U.S.) Supreme Court that have the potential to significantly impact the delivery of cancer care in the U.S.; two of the cases are currently before the Supreme Court and the third is at the appellate level. The cases—Loper Bright Enterprises v. Raimondo; Relentless, Inc. v. Department of Commerce; and Alliance for Hippocratic Medicine et al v. the U.S. Food and Drug Administration (FDA) et al—could reshape the authority of the federal agencies that regulate health care in the country. The Court is expected to issue rulings in these cases before its current session ends in June 2024.
Challenge to Federal Courts’ Deference to Federal Agencies
In 1984, Chevron v. Natural Resources Defense Council established the “Chevron deference” or “Chevron doctrine,” a legal principle that compels federal courts to defer to a federal agency's reasonable interpretation of an ambiguous or unclear statute that the U.S. Congress delegated to the agency to administer. Two cases before heard in early 2024 are currently challenging the Chevron deference (Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce) by directly questioning the power of federal regulators.
Deferring to judges and courts rather than expert administrative agencies such as the FDA, the Department of Health and Human Services, and others, could have serious implications for health care, pharmaceuticals and medical devices, and public health insurance programs like Medicare and Medicaid. It could create major disruptions in priority areas for ASCO by, for example, potentially undermining the FDA’s authority over prescription drugs and the Centers for Medicare & Medicaid Services’ authority in establishing rules affecting physician and hospital payment.
The American Cancer Society, the American Academy of Pediatrics, the American Heart Association, and other health organizations filed an amicus brief urging the Supreme Court to uphold Chevron and to continue deferring to the expert authority of federal agencies. A decision is expected in the summer of 2024.
Challenge to FDA’s Approval Authority and Access to Pharmaceuticals
The Supreme Court will also hear oral arguments on March 26, 2024, in Alliance for Hippocratic Medicine et al v. the FDA et al, a case that threatens the regulatory authority of the FDA for availability and conditions of use for drugs in the U.S.
The FDA is Congressionally mandated to evaluate the scientific and clinical aspects of all drugs submitted for approval in the United States to determine their safety and effectiveness. The FDA comprises experts from various scientific fields who evaluate the benefits and risks of drugs. And every single day, patients and their doctors depend on these evaluations, which consider factors such as the drug's risks and benefits, therapeutic context in which the drug will be used, information about the conditions it can treat or prevent, its intended use, available treatment alternatives, and more. FDA will approve a new drug only if the application includes “substantial' evidence of safety and effectiveness from adequate and well-controlled investigations.
The medication at the center of this lawsuit—mifepristone—was approved by the FDA in 2000 and is used to treat several conditions. In 2016, the agency updated and approved a new evidenced-based regimen through a similarly intensive review of safety information and evolving scientific understanding of the drug.
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. If judges and courts undermine the scientific process to block access to FDA-approved drugs and treatments, the uncertainty this would create could have a negative effect on patient access, safety, and could create a disincentive for pharmaceutical innovation. For cancer patients who suddenly find themselves without access to the best available treatments, this could mean poorer outcomes, including reduced survival and increased adverse effects.
ASCO is on the record urging the courts to uphold the FDA’s authority and not undermine the drug approval system upon which providers, patients, and drug manufacturers alike rely. In 2023, ASCO joined the American Cancer Society, the American Society of Hematology, the Leukemia & Lymphoma Society, and other health organizations in a series of amicus briefs defending access to FDA-approved drugs.
After this month’s hearing, a decision is expected in Summer 2024.
ASCO will continue to monitor these cases and will update members on the impact of the Supreme Court’s decisions on cancer care in the U.S.
Bookmark ASCO in Action or updates as well as news, advocacy and analysis on cancer policy.
