Modern medicine and public health in the US, and globally, rely heavily on agencies like the Food and Drug Administration (FDA) and Centre for Disease Control & Prevention (CDC), but a question mark now hangs over a long-standing pillar supporting them, and risks eroding their mandates to protect and promote public health.
Modern medicine and public health rely heavily on these agencies; recent examples include the FDA's proposal to improve the effectiveness of clinical tests, the CDC's guidance during the pandemic, the Environmental Protection Agency’s proposal to restrict forever chemicals, and the Consumer Financial Protection Bureau’s progress on medical debt.
Supporting these agencies is a legal doctrine called Chevron deference, granting them flexibility in fulfilling their mandates to maximise policy impact, keeping them nimble amid changing circumstances.
Now, a majority of the US Supreme Court appears poised to overturn this bedrock principle.
In JAMA Network, Daniel Aaron and Avery Emery write that the loss of Chevron could exalt policy choices made by judges over the expertise-based decisions by these executive agencies.
Chevron deference has protected the discretion of administrative agencies since 1984, when the US Supreme Court decided the case Chevron USA Inc v Natural Resource Defence Council.
This case enshrined the idea of deferring to agencies’ legal interpretations of congressional laws – as long as the interpretation was reasonable. This arrangement empowered regulatory agencies to act on their scientific and policy expertise, while retracting the role of courts in policing agency decisions, such as those by the FDA and EPA.
However, the discretion that Chevron vests in administrative agencies has become a target for those opposed to an active, regulatory government.
Two cases currently before the US Supreme Court, Loper Bright Enterprises v Raimondo and Relentless, Inc v Department of Commerce, could potentially lead to the end of Chevron.
Six commercial fishing ventures have challenged a rule requiring that fishermen pay the cost of government-approved observers who guard against illegal overfishing.
Although the lower courts in both cases upheld the regulation under Chevron, the fisheries argue that the rule and Chevron itself threaten the way of life for small, family-owned businesses.
Justice Gorsuch was receptive, expressing concern that Chevron places a thumb on the scale in favour of the government at the expense of “Social Security Disability applicants who have no power to influence agencies”.
Justice Kavanaugh, meanwhile, said the judiciary’s historic role has been “to police the line between the legislature and the executive to ensure the latter is not operating as a king”, seemingly implying Chevron places agencies in the position of royalty.
Far beyond fisheries, this case raises questions about who decides legal and policy questions at the core of medicine, public health, and the environment.
Chevron embodies into law the recognition that when Congress passes a law with gaps or ambiguities, health- and policy-minded agencies have the expertise to understand what Congress intended, and are best placed to maximise the public benefits flowing from the law.
Regulated industries oppose this deference, as it gives the agencies greater leeway in implementing regulations that can reduce revenue.
Careful balance
Chevron struck a delicate balance among Congress, agencies, and the judiciary that has been relied upon for 40 years.
This balance has tempered the effect that partisanship plays in judicial decision-making, as researchers have demonstrated that liberal and conservative judges alike are three to four times more likely to uphold an agency’s interpretation of a statute to which they would be politically opposed when analysing it using Chevron vs when Chevron is not invoked.
Chevron also protects public health experts from being second guessed by judges; between 2000 and August 2022, the FDA won every case in which an appeals court found a statute was unclear and thus applied Chevron deference.
In that same period, when appeals courts found a statute was clear and thus granted no deference to the agency, the courts sided with the FDA less than half of the time.
Legal experts know well that the US Supreme Court has refused to defer to an agency using Chevron since 2014.
The Court appears to be trying to replace deference to agencies with anti-deference. In West Virginia v EPA (2022), it definitively instituted the modern major questions doctrine (MQD), a court-created rule that congressional authorisation must be clear for agencies to adopt rules of major significance (what is major is decided by the court).
The Supreme Court then struck down the EPA’s Clean Power Plan regulating power plants, finding it major, despite Chevron still being binding precedent. The Supreme Court had previously relied on the MQD, although without yet formally naming it, to strike down the Occupational Safety and Health Administration’s (OSHA’s) SARS-CoV-2 vaccine mandate for large employers and the CDC’s eviction moratorium during the Covid-19 pandemic.
This anti-deference at the Supreme Court has increasingly been adopted by the lower courts, demonstrating what a future without Chevron would look like.
The FDA has suffered repeated losses when lower courts have failed to defer under Chevron to long-standing FDA precedents.
Recent court decisions have held unlawful an FDA policy on orphan drugs in Catalyst Pharmaceuticals v Becerra (US Court of Appeals, 11th Circuit; 2021) and the FDA’s separating line between human drugs and medical devices in Genus Medical Technologies LLC v FDA (US Court of Appeals, DC Circuit; 2021).
The loss of Chevron would also make it more difficult for agencies to implement national policies, as EPA regulations of power plants, OSHA workplace health standards, or FDA tobacco rules could be upheld in one part of the country and struck down in another, as judges of different ideologies may read a law differently.
This could ultimately lead to the aggrandisement of the Supreme Court’s power, as conflicting legal interpretations would be resolved conclusively by that court – which also increased the discretion of the US President in appointing and removing agency heads, greatly expanding the role politics plays in running administrative agencies at the expense of consistency and expertise.
The President can fire the head of the FDA at any time, for any reason; this may have helped foster mistrust in SARS-CoV-2 vaccines during the pandemic, when President Donald Trump allegedly threatened to fire FDA Commissioner Stephen Hahn if he did not approve a vaccine in 24 hours.
Eliminating Chevron, which has stood as the centrepiece of US administrative law for four decades, would further erode the ability of these agencies to act in ways that promote public health and the environment, while aggrandising a US Supreme Court that has demonstrated a willingness to ignore scientific expertise
Implications if Chevron overturned
Although the Supreme Court has not invoked Chevron in nearly a decade, lower courts regularly rely on this deference, point out Sahil Agrawal, Joseph Ross and Reshma Ramachandran in JAMA, adding that the Supreme Court’s upcoming decision would not only disempower regulatory agencies, but also unsettle thousands of existing regulations essential to predictable medical product regulation and the stable administration of Medicare and Medicaid.
Courts are not passive actors when they apply Chevron; on the contrary, they defer to an agency’s construction only if, after applying all canons of statutory interpretation, they independently agree that the statute is ambiguous and the agency’s interpretation falls within reasonable bounds.
The presumption of deference also does not give a carte blanche to agencies, as they must still act within the bounds of discretion that Congress granted in the enabling statute and that courts can check using other administrative law principles.
Furthermore, any shifts in agency interpretation between presidential administrations reflect policy choices and regulatory priorities endorsed by the public through elections, and significant changes will be politically accountable.
The FDA and CMS have, for decades, regulated medicine and public health in reliance of these principles. Both agencies must administer statutes that confer broad regulatory authority but that also contain open-ended and ambiguous provisions that can be subject to multiple interpretations.
For example, the FDA must assess whether a new drug application provides “substantial evidence” of effectiveness from “adequate and well-controlled investigations,” but the statute itself provides little guidance as to when evidence is substantial or when an investigation is adequate and well-controlled.
So, the FDA and CMS must exercise their accumulated expertise and experience to issue regulations specifying the precise criteria by which they will enforce the statutes and offering guidance to the regulated industries.
These regulations, which often balance various policy considerations, govern everything from clinical study standards, post-market safety evaluations, and product labelling specification to insurance coverage requirements, reimbursement, and management of fraud and waste.
The agencies also issue new or revised regulations routinely, on average, every fortnight, to ensure the programmes remain responsive to new evidence-based treatment practices and changing needs.
The FDA and CMS can only issue informed, authoritative, and responsive regulations if their expert judgment is not subject to routine second-guessing through the courts.
Overturning Chevron could invite legal challenges to any and all agency determinations of ambiguous statutes by any stakeholder, leaving individual courts with the impractical task of determining the “correct” meaning of statutes without requisite expertise, practical experience, or public engagement.
The spillover effects for medicine and public health, in turn, will be consequential.
The heightened threat of legal challenges and judicial scrutiny over agency decisions will, in itself, create uncertainties and instability for both agencies and regulated industries.
Without Chevron, agencies may have to contend with the uncertain prospect of emboldened litigants regularly challenging their regulatory authority, and private actors may become risk averse, reducing investments in innovative drugs and healthcare technologies because they cannot anticipate the regulatory or litigation risks.
A decision undermining Chevron will also immediately open to litigation scores of public health regulations that play an essential role in consumer protection and healthcare access.
Apart from courts being ill-equipped to make scientific determinations, even if a given court were to agree with the agency’s interpretation, a future court would not be foreclosed from revisiting and invalidating the decision in Chevron’s absence.
Successful challenges to existing and future regulations could lead to inconsistent rulings in different jurisdictions, creating confusion and costs for stakeholders.
Agencies would be burdened with defending even routine regulations in multiple courts countrywide, each overseen by different judiciaries that differ in their interpretation of the law and in their medical and public health expertise.
Routine interference by courts in agency decisions could, more broadly, amplify the troubling increase in public distrust of scientific institutions and make efforts to confront public health challenges more difficult.
Courts should not become policymakers. Shifting the interpretive burden to non-expert courts therefore risks threatening the credibility and legitimacy of public health initiatives.
The US Supreme Court’s final decision in Loper Bright Enterprises v Raimondo and Relentless, Inc v Department of Commerce threatens to roll back the very regulations that have advanced medicine and public health through medical product regulation, reduced disparities in healthcare access and coverage, and allowed for deliberate and informed responses to public health crises.
Expecting Congress to draft legislation with sufficient detail to account for all possible regulatory scenarios and unforeseen circumstances is unrealistic.
JAMA Network article – Supreme Court Limits on the Power of US Health Agencies (Open access)
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