A worker organizes vaping supplies in Jersey City, New Jersey, in 2020. In the wake of the Chevron deference rollback, e-cigarette companies may find it easier to challenge FDA regulations, experts say. The June Supreme Court decision could have wide implications for public health policies.
Photo by Eduardo Munoz Alvarez, courtesy Getty Images
“This is going to have a huge chilling effect on federal agency actions.”
— Andrew Twinamatsiko
The U.S. Supreme Court released a flurry of rulings this summer that will have implications for U.S. public health, from reproductive health care to air pollution. But the decision that is expected to have the broadest and possibly worst impact on public health is also probably the least understood by the general public.
In Loper Bright Enterprises v. Raimondo on June 28, the Supreme Court overturned a 40-year legal precedent known as the “Chevron deference.” The end of the policy means courts will be able to sidestep the expertise of federal health agencies when interpreting U.S. laws — a course that experts say has the potential to harm public health policy in incalculable ways.
“This is going to have a huge chilling effect on federal agency actions,” Andrew Twinamatsiko, JD, director of the Health Policy and Law Initiative at the O’Neill Institute for National and Global Health Law at Georgetown University, told The Nation’s Health.
The Chevron deference arose from Chevron v. Natural Resources Defense Council, a 1984 case that focused on the interpretation of language in the Clean Air Act. The Supreme Court ultimately deferred to the Environmental Protection Agency’s expertise to decide the case, which dealt with pollution controls at power plants.
That action set a precedent that courts should consider the knowledge of scientists and officials at federal agencies — such as the Centers for Disease Control and Prevention, the Food and Drug Administration, the Department of Health and Human Services, and the Centers for Medicare and Medicaid Services — that are implementing laws.
Congress tends to broadly write public health laws, often using open-ended phrases such as “in the public interest” or “to promote health.” Since the Chevron case, federal agencies have used their expertise to fine-tune statutes, such as EPA creating rules to limit carbon emissions, CMS ensuring basic medical services are covered in health insurance plans and FDA regulating the safety of drugs and vaccines.
“If Congress has clearly spoken on an issue being challenged in court, we have to abide by Congress’ language,” said Twinamatsiko, summarizing the Chevron deference. “But if the statute is unclear or ambiguous, then we will not second-guess an agency’s interpretation of that statute if the interpretation is reasonable.”
That changed in June when the high court overturned the Chevron policy. Rather than relying on expertise from health and regulatory federal agencies, courts will now be able to interpret and decide how public health laws apply on their own. That means rules could be weakened or eliminated through court rulings on pollution, clean water, Medicaid, Medicare, food and drug safety, civil rights, occupational safety and more.
While potentially devastating, the decision was not surprising, according to experts. In recent years, the federal judiciary — a third of whom were appointed during the Trump administration — has decided numerous cases that limit public health authority. And during the pandemic, the Supreme Court ruled against CDC and the Occupational Safety and Health Administration in separate cases that overturned actions to slow COVID-19 spread. In 2022, the high court curtailed EPA’s ability to regulate power plant emissions in its decision in West Virginia v. EPA.
“We have some discretion for interpretation, but the courts recently have limited or have taken a view for the most part that federal agencies have limited discretion to interpret rules,” FDA Commissioner Robert Califf, MD, said at APHA’s Policy Action Institute, just a few days prior to the Loper decision.
Experts predict an increase in lawsuits in the wake of the June ruling.
“It’s going to be a scramble, a race to the courthouse,’ said Linda Tvrdy, JD, PhD, senior legal program manager for the Center for Health Policy and Law at Northeastern University School of Law. “We are going to see more litigation.”
Likely to be on the table are challenges to statutes involving Medicaid, Medicare and the Affordable Care Act; food, drug and vaccine regulation; and artificial intelligence and machine language software in health care; said Joseph Ross, MD, MHS, a professor of medicine and public health at Yale School of Medicine.
Pharmaceutical companies are already challenging CMS’ authority to negotiate drug prices as part of the Inflation Reduction Act of 2022, Ross said, and ambiguities exist in CMS’ reach in regulating public health insurance. In coming years, many people on Medicaid may no longer be eligible and prices on some drug medications could dramatically rise, he predicted.
FDA could also be vulnerable to legal challenges, such as regulation of the multi-billion dollar e-cigarette market. E-cigarettes are highly toxic and lead to behavioral and other health issues in young people, studies show. Most e-cigarettes also contain nicotine, which is addictive.
E-cigarette companies may now find it easier to challenge agency regulations. Companies denied by FDA may sue by claiming the agency misinterpreted the statute, leaving it up to a judge to decide the outcome, Ross said.
Another potential outcome of the Loper ruling is that as lawsuits wind through the courts, federal regulators may become more risk averse. They may regulate more cautiously to avoid legal challenges, Ross said.
“They’re going to be less likely to want to try new things that could then be challenged in the courts,” he told The Nation’s Health.
Jurisdictions may also vary widely in their decisions depending on a federal judge’s independent ruling, Twinamatsiko said.
In 2023, two conflicting federal court rulings — one in Texas and one in Washington — were made on abortion medication and FDA’s authority to regulate drugs, he noted. The result was conflicting orders to both maintain and suspend approval of a drug that is used to end a pregnancy.
“Until the Supreme Court steps in, which could take years, we’re bound to have inconsistency in the federal regulatory landscape,” Twinamatsiko said.
Public health advocates will need to be active in local, state and federal government work to make sure rational voices are heard on important issues such as childhood nutrition, gun violence, drug overdoses, vaccines and public health funding, supporters say. And when elected members of Congress are considering a bill impacting public health, advocates will need to offer expertise and evidence-based science to aid lawmakers drafting it.
“When they’re working on legislation or amending past legislation that now needs to be clarified, we have to be as available as possible to lend our expertise,” Ross said.
For more information on the Chevron deference, visit www.nrdc.org.
- Copyright The Nation’s Health, American Public Health Association
