A supreme court decision that overturned the “Chevron doctrine” could upend regulations on everything from tobacco to pharmaceuticals to surprise medical bills, experts told the Guardian.
The 40-year-old legal framework, the Chevron doctrine, once directed courts to defer to the expertise of federal agencies, such as the US Food and Drug Administration (FDA).
In a far-reaching decision, the court’s conservative supermajority held last week in Loper Bright Enterprises v Raimondo and Relentless Inc v Department of Commerce that the reverse should apply, with courts having the final say over even highly technical regulations.
“This was a gut punch for health, safety and the environment in the US,” said Prof Lawrence O Gostin, an expert in health law and a professor at Georgetown Law’s O’Neill Institute. “There’ll be no area where agencies act to protect the public’s health or safety or the environment that won’t be adversely affected by this ruling.”
Liberal Justice Elena Kagan predicted the decision would “jolt” the legal system by dispensing with a framework that had become part of the “warp and woof of modern government.”
Combined with a second, less high-profile ruling that expanded the time for people to sue agencies, experts said the end of the Chevron doctrine is certain to be felt in the everyday lives of Americans.
For instance, the tobacco industry may have an easier time challenging controversial regulations on vaping products; drug makers could face new uncertainties as they invest millions in new research and development; and it may be easier for doctors to argue against rules that prohibit sending patients surprise medical bills. In turn, agencies may divert funding from staff experts, such as scientists, to attorneys, who can defend their decisions.
At the same time, the court’s opinion was cheered by big business and Republican allies. Senator Mitch McConnell said the decision “leaves no room for an unelected bureaucracy to co-opt this authority for itself”, CNBC reported.
The Chevron doctrine is named for the 1983 supreme court case Chevron v Natural Resources Defense Council (NRDC). In the heart of the Reagan administration’s de-regulatory efforts, the court sided with the US Environmental Protection Agency (EPA), which at the time issued a regulation environmental advocates viewed as friendly to industry.
Chevron quickly became a landmark opinion. By the late 1980s, the Chevron framework appeared in up to 40% of supreme court opinions, growing to 60% by the 1990s. One of the doctrine’s greatest proponents was conservative Justice Antonin Scalia, according to an article by Columbia Law School professor Thomas Merrill, a Federalist Society contributor and an expert on the doctrine. As of 2014, Chevron was accumulating roughly 1,000 new legal citations per year by lower courts.
“It is not overstating the matter to say that Chevron has become one of a handful of decisions – along with Marbury v Madison, Brown v Board of Education, and Roe v Wade – that are the material for a continuing collective meditation about the role of the courts and indeed of the law itself in the governance of our society,” Merrill wrote.
What changed philosophically for conservatives is a matter of debate. The supreme court had not cited Chevron in its last eight years of decisions, ScotusBlog reported.
What is not in question is how the political landscape has changed since the 1980s, when courts deferred to Reagan’s de-regulatory agencies. The nation’s courts are now much more conservative, because the Trump administration successfully appointed nearly one-third of the federal judiciary.
In a dissent by liberal justice Elena Kagan, and joined by liberal colleagues Ketanji Brown Jackson and Sonya Sotomayor, the justice wrote that the court had, “in one fell swoop,” given “itself exclusive power over every open issue – no matter how expertise-driven or policy-laden – involving the meaning of regulatory law”.
The decision could have particularly resounding consequences for agencies with highly technical work, such as the FDA, the Environmental Protection Agency (EPA) and the Centers for Medicare and Medicaid (CMS), experts said.
“The case has profound implications on the FDA in particular, because over time we’ve had so many new innovations come before the agency,” said Dr Reshma Ramachandran, an assistant professor of family medicine at Yale School of Medicine and a health policy expert.
Without the Chevron doctrine directing courts to defer to agencies’ expertise, judges may be the final arbiters of questions about how to regulate a new cell or gene therapy, “that doesn’t really fall under the statutory definitions,” from the 1960s, she said.
“This goes back to one of the questions [justices] asked the attorneys who challenged Chevron deference,” Ramachandran said. “Do you think the courts have sufficient expertise for judges to determine the difference between a drug and a nutritional supplement?”
Or, to name a few more technical questions of law – what is a medical device for regulatory purposes? Is a diagnostic test a medical device? Or, to take an example used by Kagan, how should Medicare measure a geographic area for the purpose of determining payments to physicians?
Overturning Chevron is not likely to upend administrative agencies overnight – agencies will still be able to put forth regulations, collect data and issue regulations and guidance.
“It’s still a little bit early to figure out how Congress is going to change writing and bills,” said Jeffrey Davis, a health policy consultant at McDermott Consulting, a lobbying and policy firm in Washington.
However, Davis said the ruling will put more pressure on Congress to be more explicit in its intent. And more pressure on Congress may mean more influence from special interest groups during bill drafting.
Healthcare is already Washington’s most monied industry group. In 2023, pharmaceutical and health products companies spent $382m lobbying federal lawmakers, according to OpenSecrets, a research group that tracks spending.
The ruling could also supercharge “court shopping,” when attorneys seek friendly venues. In just one recent example of court shopping, attorneys seeking to undermine FDA approval for the medication abortion drug mifepristone brought the case in a highly conservative district court in Texas, where the judge was known to hold anti-abortion views, and ultimately ruled in their favor.
“There’s certain courts across the country that are going to be very, very busy,” said Davis.
