How Overturning the Chevron Doctrine Could Impact Public Health, FDA

Legal experts and health officials expect a flood of lawsuits that will complicate regulation of drugs, tobacco and cutting-edge medical technologies. The administration of government health insurance programs could become even more embroiled in lawsuits. And Agency decisions made over decades could be exposed to new challenges.

The full implications of the court’s term, which ended Monday, could take years for legal experts and health policymakers to unravel. What’s clear is that the high court has sent a seismic shock through an administrative state that has been targeted by conservatives and industry for years.

“This period has been catastrophic for public health in many ways,” said Reshma Ramachandran, a health policy expert and assistant professor at Yale School of Medicine.

The Supreme Court on Friday, Loper Bright Enterprises v. Raimondoissued perhaps its most important decision to limit the powers of federal agencies, overturning a legal precedent — set in 1984. Chevron vs. Natural Resources Defense Council — that federal judges should defer to agencies when the law is ambiguous or Congress does not specify its intent. Although initially supported by conservatives, Chevron This doctrine has been seen as an example of abuse of power by unelected and irresponsible bureaucrats.

In announcing the end of the doctrine, Justice John G. Roberts Jr. wrote that agencies have “no special authority” to resolve statutory ambiguities — but courts do.

The 6-3 decision, split along ideological lines, could bog down the health agency’s rulemaking on a range of issues, from controversial tobacco rulemaking to more mundane billing issues. Health agencies could become more cautious, devoting more resources to preparing for the onslaught 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 routinely boasts that it regulates 21 cents of every dollar spent in America. It makes risky rulings on drugs, tobacco products and food additives — what is safe and effective to put in your mouth or inject into your arm.

Justice Elena Kagan, in her dissenting opinion, said government regulators are best placed to handle highly technical topics. To prove her point, she asked two complicated health care questions: What qualifies as an FDA-regulated protein? And how should the Medicare program measure “geographic area” when calculating hospital reimbursements based on wage levels in specific regions?

The FDA declined to comment on the decision. The White House called Chevron decision “another deeply troubling decision that sets our country back,” adding that President Biden’s legal team will work with federal agencies to do “everything we can to continue to leverage the extraordinary expertise of federal employees.”

On Capitol Hill, Republicans praised the Supreme Court ruling that overturned Chevron doctrine, and Republican leaders in the House of Representatives pledged to quickly ensure that agencies comply with the supreme court’s ruling.

The review could also have implications for the agency’s authority to respond to health emergencies like the coronavirus pandemic, said Andrew Twinamatsiko, director of Georgetown University’s O’Neill Institute’s health policy and legal initiative.

“This is really going to have a strong chilling effect on what agencies can do to anticipate health emergencies or disasters,” he said of the court’s decision.

Companies and opponents of controversial drugs can also attack the FDA’s decisions to approve new drugs, challenging its actions by interpreting ambiguous federal law. “So many of the laws that govern drug approval are really vague,” said Holly Fernandez Lynch, an assistant professor of medical ethics and law at the University of Pennsylvania.

For example, approval of new drugs should be based on “substantial” evidence based on “adequate and well-controlled studies” — which the agency interpreted to mean studies that included a controlled group, minimized age and gender bias, and standardized doses.

“One judge who has no scientific training could come forward and say the FDA misinterpreted ‘adequate and well-controlled investigations,’” Ramachandran said. “That’s a recipe for disaster.”

The decision to roll back the doctrine does not necessarily mean a sudden change in policy for drugmakers, TD Cowen said, but it could have implications for how the agency regulates emerging technologies such as artificial intelligence, nanotechnology and digital therapeutics.

Stuart Pape, a former deputy general counsel for the FDA, predicts the ruling will hurt the agency’s chances of succeeding in efforts to require labels on food packages and regulate some laboratory tests that he says can be unreliable.

Supreme Court Ruling in Chevron Case could also create more challenges for 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 developing changes to the Medicaid drug reimbursement program, experts said.

“The big question mark is whether agencies like the Centers for Medicare and Medicaid Services will be less amenable to these kinds of innovative interpretations of the law to solve difficult policy problems,” said James Huang, a partner at health care law firm Hogan Lovells.

Health care providers that have had their Medicare payments suspended because of suspected fraud or failure to follow federal procedures may also benefit from another Supreme Court decision issued last week, said Andrew Tsui, a former CMS attorney who now practices health care at Greenberg Traurig.

In this decision, Securities and Exchange Commission v. Jarkesythe justices ruled that the agency was wrong to rely on administrative hearings — rather than federal courts — to initiate 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 enacted by Congress.”

Legal battles to comply with the agency could also extend to cases involving tobacco products regulated by the FDA, which is continually embroiled in industry litigation.

Tobacco companies will try to take advantage of the loss Chevron doctrine to thwart the Biden administration if it presses for long-delayed rules banning menthol cigarettes, said Mitch Zeller, former director of the FDA’s Center for Tobacco Products. He said he fears the industry will be emboldened to find a sympathetic judge prepared to rule that the agency misinterpreted federal law.

“From a public health perspective, it would be deeply troubling if a single conservative judge wanted to replace experts in evaluating science,” Zeller said.

The vaporization industry has already given the signal fall Chevron The doctrine will bolster ongoing legal battles with the FDA over millions of denials of e-cigarette products. The Supreme Court will decide this year whether to accept legal questions about how the FDA is handling vaping regulations.

“The Tobacco Control Act is ambiguous on the standard of what is ‘appropriate to protect the public health,’” said Tony Abboud, president of the Vapor Technology Association, adding that the ruling strengthens his contention that the FDA “overstepped its authority when it decided to impose a de facto ban on flavored e-cigarettes.”

Supreme Court decision from Monday Corner Post vs. Federal Reserve Board of Governors adds another conundrum to the changing regulatory landscape in health care. The justices ruled in favor of a North Dakota roadside bar that argued it should be allowed to challenge a federal regulation on debit card swipe fees because the roadside bar’s business was not incorporated until the six-year statute of limitations on the fees expired. Federal law provides for a six-year statute of limitations for challenging the regulations.

The Biden administration has argued that a ruling extending the statute of limitations could threaten decades-old regulations. During oral arguments in a case over access to the abortion pill mifepristone, U.S. Attorney General Elizabeth B. Prelogar suggested that doctors could sue over drug approvals issued decades ago if the Supreme Court were to rule against the administration in Corner post.

Two years after the Supreme Court struck down a constitutional right to abortion, the justices of this term have essentially rejected the FDA’s approval of mifepristone and emergency abortions. But legal experts say the issues will eventually return to the justices for consideration.

In his strong opposition on Monday Corner postJustice Ketanji Brown Jackson suggested the mifepristone case would be a “fair subject” for a new lawsuit, even though the statute of limitations for challenging the drug, approved in 2000, has long since expired.

“From now on, administrative bodies can be sued indefinitely for any final decision they make,” she wrote.