What is Chevron deference, how did it come to be, and what were the implications for FDA?
Chevron deference was established by the 1984 Supreme Court of the United States (SCOTUS) case of Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., which related to EPA’s ability to regulate air quality under the Clean Air Act. The decision mandated that federal courts defer to federal agency’s reasonable interpretation of ambiguous statutes.
For forty years, this has empowered agencies like the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and Centers for Medicare and Medicaid Services (CMS) to have the flexibility to adapt existing regulations to rapidly changing scientific advancements and address the country’s pressing public health needs.
What are the potential implications of overturning Chevron’s deference on the FDA’s ability to oversee the regulation of cancer treatments?
The SCOTUS decision on June 28th to overturn the Chevron doctrine marks a significant shift in federal policy, particularly health policy impacting the FDA. Critical decisions on complex healthcare laws may now fall to courts rather than FDA experts, affecting drug accessibility, coverage, and enforcement of health standards.
Without this doctrine, FDA is more susceptible to lawsuits from companies or interest groups challenging their regulatory decisions surrounding cancer therapies. The added layer of legal scrutiny has the potential to slow the adoption of innovative regulatory approaches like the breakthrough therapy designation, the use of new technologies like A.I., and disrupt public health initiatives such as vaccination programs and tobacco and substance use regulation.
This shift will require Congress to draft much more concise legislation surrounding all of FDA’s many duties, and those laws will need frequent updates in an attempt to keep pace with scientific innovation.
How might the Chevron decision impact patients and their access to new treatments?
The Supreme Court’s decision to overturn Chevron deference could significantly delay patient access to new treatments due to increased litigation and regulatory uncertainty.
Legal scrutiny and uncertainty can slow medical innovation, burden healthcare providers, and hinder timely access to new treatments.
For example, if the FDA decides to approve a new cancer drug based on its interpretation of ambiguous provisions within the Food, Drug, and Cosmetic Act (the law that outlines FDA authorities to regulate food, drugs, and cosmetics), it’s interpretation might be challenged in court, arguing that the agency exceeded its statutory authority. This could lead to prolonged court battles, delaying the drug’s availability to patients who need it.
Additionally, the lack of deference to FDA experts might result in inconsistent rulings from different courts, creating uncertainty about the drug approval process and potentially causing delays in the development and market introduction of new cancer therapies.
Broader public health initiatives, like provisions from the Affordable Care Act aimed at promoting early detection and preventive care and guidelines requiring coverage for cancer screenings, could be inconsistently applied, leading to disparities in early detection efforts.
All of this further emphasizes the urgent need for our community to understand and address this decision’s impact on the federal agencies, the healthcare system, and patient lives. We and our colleagues in science, advocacy and policy will monitor future potential litigation based on this current state of legal affairs, and how the courts come down in those cases. Future legislation and policy action will likely be needed to assure that the FDA can continue to carry out its mission effectively.
