Legal experts and health officials expect a flood of litigation that will complicate the regulation of drugs, tobacco products and cutting-edge medical technologies. The administration of the government’s health insurance programs could become even more mired in lawsuits. Decisions made by agencies decades ago may once again be vulnerable to challenge.
It could take years for legal experts and health policymakers to untangle the full ramifications of the Supreme Court’s term, which ended Monday. What is clear is that the Supreme Court has delivered an earthquake to the administrative state that has been in the crosshairs of conservatives and industry for years.
“This quarter has been disastrous for public health in many ways,” said Reshma Ramachandran, a health policy expert and assistant professor at Yale School of Medicine.
The Supreme Court ruled on Friday, Loper Bright Enterprises v. Raimondoissued perhaps the most consequential of his rulings limiting the power of federal agencies, overturning a legal precedent—set in 1984—in Chevron v. Natural Resources Defense Council — that federal judges should defer to agencies when a law is ambiguous or Congress fails to make its intentions clear. Although initially championed by conservatives, the Chevron This doctrine has been vilified as an example of abuse of power by unelected and unaccountable bureaucrats.
In declaring the doctrine dead, Justice John G. Roberts Jr. wrote that agencies “have no special jurisdiction” to resolve statutory ambiguities — but courts do.
The decision, by a six-to-three judge split along ideological lines, could tighten rules for health agencies on a range of issues, from controversial tobacco regulations to more mundane billing questions. Health agencies could become more cautious, devoting more resources to preparing for a flood of lawsuits, several legal experts and former federal health officials said.
Among the agencies likely to be affected by the court’s decisions is the Food and Drug Administration, which regularly boasts that it regulates 21 cents of every dollar spent in the United States. It makes high-stakes decisions about drugs, tobacco products and food additives — what’s safe and effective to put in your mouth or inject into your arm.
Justice Elena Kagan argued in her dissent that government regulators are best suited to tackle highly technical issues. To support her argument, she posed two complex health care questions: What constitutes a protein that the FDA regulates? And how should the Medicare program measure a “geographic area” when calculating reimbursements to hospitals based on wage levels in certain regions?
The FDA declined to comment on the decision. The White House called the Chevron decision “another deeply troubling decision that sets our country back,” adding that President Biden’s legal team would work with federal agencies to do “everything we can to continue to deploy the extraordinary expertise of the federal workforce.”
On Capitol Hill, Republicans hailed the Supreme Court’s decision overturning the Chevron doctrine, with House Republican leaders pledging to quickly ensure that agencies follow the high court’s decision.
The review could also affect the agency’s powers to respond nimbly to health emergencies such as the coronavirus pandemic, said Andrew Twinamatsiko, director of Georgetown’s Health Policy and the Law Initiative at the O’Neill Institute.
“This will really have a strong deterrent effect on what agencies can do to anticipate health emergencies or health disasters,” he said of the court’s decision.
Companies and opponents of controversial drugs can also take aim at the FDA’s decisions about approving new drugs, challenging actions that rely on interpretations of ambiguous federal law. “A lot of the drug approval law has very vague language,” said Holly Fernandez Lynch, an assistant professor of medical ethics and law at the University of Pennsylvania.
Approvals of new drugs, for example, are supposed to be based on “substantial” evidence from “adequate and well-controlled investigations” — which the agency has interpreted to mean studies that include a control group, minimize age and sex bias, and standardize doses.
“A single judge with no scientific training could step in and say the FDA misinterpreted the concept of ‘adequate and well-controlled investigations,'” Ramachandran said. “That’s a recipe for disaster.”
The decision to reverse the doctrine doesn’t necessarily mean sudden changes in policies affecting drugmakers, according to law firm TD Cowen, but could impact how the agency regulates emerging technologies such as artificial intelligence, nanotechnology and digital therapeutics.
Stuart Pape, a former FDA deputy general counsel, predicted the ruling would hurt the agency’s chances of succeeding in its attempts to require front-of-package labels on food and to regulate some lab tests that it says may be unreliable.
The Supreme Court’s decision in the Chevron case It could also lead to new challenges to the Medicare and Medicaid programs. Officials often use new interpretations of the law to establish new, sometimes divisive, policies, such as defining the terms of Medicare drug negotiations or crafting changes to Medicaid’s drug reimbursement program, experts said.
“A big question is: Will agencies like the Centers for Medicare and Medicaid Services be less receptive to these kinds of innovative interpretations of the law to solve difficult policy problems?” said James Huang, a partner at the health care law firm Hogan Lovells.
Health care providers suspended from receiving Medicare payments due to suspected fraud or failure to follow federal procedures could also benefit from another Supreme Court ruling issued last week, said Andrew Tsui, a former CMS attorney who now manages health care records for the law firm Greenberg Traurig.
In this decision, Securities and Exchange Commission v. JarkesyThe justices ruled that the agency had improperly relied on administrative hearings — not federal courts — to bring enforcement actions and impose fines. In her dissenting opinion, Justice Sonia Sotomayor wrote that “dozens of agencies could be stripped of their authority to enforce laws passed by Congress.”
Legal battles over deference to agencies could also play out in cases involving tobacco products regulated by the FDA, which is perpetually mired in litigation filed by the industry.
Tobacco manufacturers will try to use the loss of Chevron Biden’s doctrine could thwart the Biden administration’s decision to implement the long-delayed rule to ban menthol cigarettes, said Mitch Zeller, former director of the FDA’s Center for Tobacco Products. He said he worries that the industry will be emboldened to find a sympathetic judge willing to rule that the agency misinterpreted federal law.
“It would be deeply troubling from a public health perspective for a single conservative justice to seek to replace the role of experts in evaluating science,” Zeller said.
The vaping industry has already signaled the disappearance of the Chevron The doctrine will bolster ongoing legal battles with the FDA over millions of e-cigarette product marketing denials. The Supreme Court will decide this year whether to accept legal questions about the FDA’s handling of vaping regulations.
“The Tobacco Control Act is ambiguous on the standard of what is ‘appropriate to protect the public health,’” said Tony Abboud, director of the Vapor Technology Association, adding that the decision reinforces his claim that the FDA “exceeded its authority when it chose to implement a de facto ban on flavored e-cigarettes.”
The Supreme Court’s decision on Monday in Corner Post v. Board of Governors of the Federal Reserve adds another hurdle to the changing regulatory landscape in health care. The justices ruled in favor of a North Dakota truck stop that argued it should be allowed to challenge a federal regulation on debit card swipe fees because the truck stop company was not incorporated before the six-year statute of limitations on fee regulations expired. Federal law sets a six-year statute of limitations for challenging regulations.
The Biden administration had argued that a decision extending the statute of limitations could jeopardize decades-old regulations. During oral arguments in a case over access to the abortion pill mifepristone, U.S. Solicitor General Elizabeth B. Prelogar suggested that doctors could sue over decades-old drug approvals if the Supreme Court ruled against the administration in court. Corner post.
Two years after the Supreme Court struck down the constitutional right to abortion, the justices in this legislature have largely cast doubt on the FDA’s approval of mifepristone and emergency abortions. But legal scholars believe those issues will one day return to the justices for review.
In his strong dissent on Monday at Corner postJustice Ketanji Brown Jackson suggested that the mifepristone case would be “a legitimate target” for a new trial, even though the statute of limitations for challenging the drug, approved in 2000, had long since expired.
“Starting today, administrative agencies can be sued in perpetuity for every final decision they make,” she wrote.