Recent Supreme Court decisions curbing the power of federal agencies will hamper government efforts to protect public health, legal experts warn. The rulings will make it harder for some federal agencies to take enforcement action, give judges more latitude to criticize agency decisions and, after a decision Monday, make it easier to challenge long-settled regulations.
Legal experts and health officials expect a flood of lawsuits that will complicate the regulation of drugs, tobacco products and advanced medical technologies. The administration of government health insurance programs could become further mired in litigation. And Decades-old decisions by government agencies may once again be vulnerable to challenge.
It could be years before legal experts and health policymakers unravel the full implications of the court’s term, which expired Monday. What is clear is that the high court has delivered a seismic shock to an administrative state that has long been in the crosshairs of conservatives and industry.
“This term has been disastrous for public health in many ways,” said Reshma Ramachandran, a health policy expert and assistant professor at the Yale School of Medicine.
The Supreme Court ruled on Friday Runner Bright Enterprises vs Raimondohas perhaps made the most consequential decision, curtailing the power of federal agencies and overturning a legal precedent established in 1984 Chevron v. Natural Resources Defense Council — that federal judges must defer to agencies when a law is ambiguous or Congress fails to specify its intent. Although initially advocated by conservatives, Chevron The doctrine was vilified as an example of power abuse by unelected and unaccountable bureaucrats.
In declaring the doctrine’s demise, Justice John G. Roberts Jr. wrote that agencies have “no special authority” to resolve legal ambiguities, but courts do.
The 6-3 ruling, divided along ideological lines, could bog down health agencies’ rules on a range of issues, from controversial tobacco regulations to more mundane matters involving billing. Health agencies could become more cautious and devote more resources to preparing for a flood of lawsuits, several legal experts and former federal health officials said.
One agency likely to be affected by the court’s rulings is the Food and Drug Administration, which routinely boasts that it regulates 21 cents of every dollar spent in America. It makes high-stakes decisions about medications, tobacco products and food additives: what’s safe and effective to put in your mouth or jab up your arm.
In her dissent, Justice Elena Kagan argued that government regulators are best positioned to handle highly technical issues. To make her point, she raised two complicated questions about health care: What qualifies as a protein that the FDA regulates? And how should the Medicare program measure “geographical area” when calculating reimbursements to hospitals based on wage levels in certain regions?
The FDA declined to comment on the decision. The White House cited 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 leverage the extraordinary expertise of the federal workforce.”
On Capitol Hill, Republicans praised the Supreme Court ruling that Chevron House Republican leaders vowed to ensure agencies swiftly comply with the Supreme Court ruling.
That oversight could also impact agencies’ ability to respond quickly to health emergencies like the coronavirus pandemic, according to Andrew Twinamatsiko, director of Georgetown’s Health Policy and the Law Initiative at the O’Neill Institute.
“It will really have a strong chilling 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 challenge the FDA’s decisions about whether to approve new drugs, and challenge actions based on its interpretation of ambiguous federal law. “So much of the law surrounding drug approval has vague language,” said Holly Fernandez Lynch, an assistant professor of medical ethics and law at the University of Pennsylvania.
For example, new drug approvals should be based on “substantial” evidence, based on “adequate and well-controlled studies” — which the agency has interpreted as studies that include a control group, minimize age and gender differences, and standardize dosages.
“A single judge who has no scientific training whatsoever could rule that the FDA misinterpreted ‘adequate and well-controlled studies,’” Ramachandran said. “That’s a recipe for disaster.”
According to the firm TD Cowen, the decision to roll back the doctrine will not lead to sudden policy changes that affect pharmaceutical companies, but it could impact how the agency regulates emerging technologies such as artificial intelligence, nanotechnology and digital therapeutics.
Stuart Pape, a former deputy chief counsel at the FDA, predicted the ruling will reduce the agency’s chances of successfully requiring front-of-package labels and regulating certain laboratory tests that may be unreliable.
The Supreme Court ruling in the Chevron case could also pose more challenges for Medicare and Medicaid programs. Officials often use novel interpretations of the law to enact new, sometimes divisive, policies, such as defining terms for Medicare drug negotiations or making changes to the Medicaid drug rebate program, experts said.
“A big question mark 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 in the health care practice of law firm Hogan Lovells.
Health care providers that have been blocked from receiving Medicare payments due to suspected fraud or failure to comply with federal procedures may also benefit from a new Supreme Court ruling last week, according to Andrew Tsui, a former CMS attorney who now handles health care cases for the law firm Greenberg Traurig.
In that decision, Securities and Exchange Commission v. JarkesyIn 2013, the justices ruled that the agency improperly relied on administrative hearings — not federal courts — to initiate enforcement actions and impose fines. In her dissent, Justice Sonia Sotomayor wrote that “dozens of agencies could be stripped of their authority to enforce laws enacted by Congress.”
Legal battles over agency compliance can also arise in cases involving tobacco products regulated by the FDA, which is constantly embroiled in lawsuits brought by the industry.
Tobacco companies will try to compensate for the loss of the Chevron doctrine to stop the Biden administration from moving forward with the long-delayed rule banning menthol cigarettes, said Mitch Zeller, a former director of the FDA’s Center for Tobacco Products. He said he worries the industry will feel emboldened to find a sympathetic judge ready to rule that the agency has misinterpreted federal law.
“It would be deeply troubling from a public health perspective if a single conservative judge tried to usurp the role of experts in judging the science,” Zeller said.
The vaping industry has already sent signals the downfall of the Chevron doctrine will intensify ongoing legal battles with the FDA over millions of denials to market e-cigarette products. The Supreme Court will decide this year whether to entertain legal challenges to 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, head of the Vapor Technology Association, adding that the ruling supports the 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 vs. Board of Governors of the Federal Reserve adds a new wrinkle to the changing regulatory landscape in health care. Judges 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 incorporated after the six-year statute of limitations for the fee arrangement had expired. Federal law provides that there is a six-year statute of limitations for challenging regulations.
The Biden administration had argued that a ruling 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. Attorney General Elizabeth B. Prelogar suggested that doctors could sue over drug approvals that date back decades if the Supreme Court ruled against the administration in Corner post.
Two years after the Supreme Court struck down the constitutional right to abortion, the justices this term have effectively rejected the FDA’s approval of mifepristone and emergency room abortions. But legal scholars believe the issues will eventually return to the justices for consideration.
In her sharp dissenting opinion Monday in Corner postJustice Ketanji Brown Jackson suggested that the mifepristone case would be a “fair target” for a new lawsuit, even though the statute of limitations for challenging the drug, which was approved in 2000, had long expired.
“Starting today, administrative agencies can be sued forever for any final decision they make,” she wrote.
