The Supreme Court last week upended one of the underpinnings of administrative law by weakening the authority of federal health agencies to rely on technical expertise as they regulate medical products, issue coverage decisions, and respond to public health crises.
The court’s decision in two cases, Loper Bright Enterprises v. Raimondo and Relentless Inc. v. Department of Commerce, overturns a key legal doctrine known as the “Chevron deference,” a precedent set 40 years ago in the Chevron USA Inc. v. Natural Resources Defense Council case.
Prior to the June 28 ruling, the Chevron doctrine empowered federal agencies to act “based on a permissible construction of the statute”—in other words, a reasonable interpretation of the law where “Congress has not directly spoken to the precise question at issue.” Challenges to these interpretations were subject to this legal test, and where an action by the executive branch is judged to be rational, the Chevron precedent compels courts to defer to the agency’s interpretation of the law.
The impact on grant-making agencies, including NIH, is more difficult to discern at this point, sources say.
The decision will likely trigger a deluge of lawsuits seeking to amend, curtail, or end any number of rules promulgated by federal health agencies—particularly FDA and CMS—based on subject-matter expertise where the law is ambiguous.
“All agency actions are more vulnerable to get bogged down in litigation now, and the FDA is no exception. The same goes for reimbursement and coverage determinations for health services,” said Carmel Shachar, faculty director of the Health Law and Policy Clinic at the Center for Health Law and Policy Innovation and an assistant clinical professor of law at Harvard Law School.
“I think we will see more litigation in the usual ‘hot spots’ of healthcare policy, now that anti-regulation groups are emboldened by Loper,” Shachar said to The Cancer Letter. “So, agency action relating to the Affordable Care Act, reproductive care access, gender-affirming care, vaccines, and other public health requirements will be likely targets.”
On Monday, the court issued another decision that allows plaintiffs to start the clock on the six-year statute of limitations when they are affected by a federal regulation, instead of when the regulation was initially implemented. Legal experts say this amplifies the impact of the Loper decision to end the Chevron doctrine.
All agency actions are more vulnerable to get bogged down in litigation now, and the FDA is no exception. The same goes for reimbursement and coverage determinations for health services.
Carmel Shachar
In the Loper case, Supreme Court justices voted 6:3 along ideological lines to overturn the Chevron precedent, with Chief Justice John Roberts delivering the opinion of the court’s conservative majority: “Perhaps most fundamentally, Chevron’s presumption is misguided because agencies have no special competence in resolving statutory ambiguities. Courts do.”
In her dissent, Justice Elena Kagan responds: “When does an alpha amino acid polymer qualify as a ‘protein’? I don’t know many judges who would feel confident resolving that issue. But the FDA likely has scores of scientists on staff who can think intelligently about it, maybe collaborate with each other on its finer points, and arrive at a sensible answer.
“The majority disdains restraint, and grasps for power.”
In recent years, the court also voted 6:3 to end affirmative action (The Cancer Letter, June 30, 2023), and overturn Roe v. Wade (The Cancer Letter, July 1, 2022).
“[The Loper decision] should really be understood as the latest in a concerted attack on the power of federal regulatory agencies to address all types of pressing and technical policy issues in the arenas—just to list a few examples—of health, the environment, financial services, across the gamut in terms of different types of actions that affect millions of Americans,” said Zachary Baron, director of the Health Policy and the Law Initiative at the O’Neill Institute for National and Global Health Law and an adjunct professor at Georgetown Law.
“I certainly do think that this decision from last week is going to lead to more litigation and more regulatory uncertainty,” Baron said to The Cancer Letter. “The Supreme Court and certain lower courts, as well as strategic litigants—whether they be conservative state attorneys general, other ideological opponents—have already been trying to use every tool at their disposal to block a range of different healthcare regulatory initiatives, arguing that they overstep what Congress intended.”
A conversation with Baron appears in this story.
Will the Loper ruling expose public health protections and regulations to more partisan threats in the judiciary?
“I’d hesitate to assume that the judicial decisions will be partisan—ideally judges make decisions based on what they think the correct interpretation of the law is, not on their individual politics,” Harvard’s Shachar said. “But the end of Chevron will mean that courts will have an easier time substituting their own decisions in the place of agency policymaking.
“Ideally, leaders should figure out how to best educate judges on topics that require a significant amount of expertise to understand. Would we want judges to attend ‘bootcamps’ on environmental sciences, medical research, etc.? Should special masters be more in vogue? Helping give judges the tools to really understand their cases will be important.”
In the absence of the Chevron doctrine, the onus—and arguably, the burden of proof—now lies on Congress and federal agencies to pay attention to minutiae when drafting legislation and engaging the rulemaking process.
“Good drafting is always important—look at how much of the ACA got stuck in litigation because it never got properly revised,” Shachar said. “I think Loper will put more emphasis on Congress articulating clearly what it wants agencies to do, as opposed to letting agencies figure out how to operationalize Congress’s vision.
“This will be difficult, especially as Congress isn’t always an expert on topics the way the agencies are. So, I would hope for open lines of communication as Congress looks to draft legislation, so they can understand what is workable.”
Cancer groups: Ruling jeopardizes public health, innovation
The Loper decision will likely cause “significant disruption” to publicly funded health insurance programs as well as health care and drug regulation, according to a coalition of 17 medical professional societies and advocacy groups, including the American Cancer Society and the American Cancer Society Cancer Action Network.
“As leaders who share a mission to protect and advance the public’s health, our organizations are disappointed by the Supreme Court’s decision today to eliminate the long-standing rule of Chevron deference,” the coalition wrote in a statement June 28. “As we described in our amicus brief, which Justice Kagan drew on in her dissent, this rule has long helped ensure that healthcare laws are interpreted and implemented appropriately.
“Before today, Chevron deference protected the legal stability of public health programs, such as Medicare and Medicaid. It ensured that laws passed by Congress were interpreted and implemented by expert federal agencies such as the Centers for Medicare and Medicaid Services. As our amicus brief noted, large health programs such as Medicaid and Medicare, as well as issues related to the Food, Drug and Cosmetic Act, are extremely complex, so it is key that decisions about how to interpret and implement relevant laws are made by experts at government agencies. Yet today’s majority opinion explicitly ends the use of this sensible doctrine.
When does an alpha amino acid polymer qualify as a ‘protein’? I don’t know many judges who would feel confident resolving that issue. But the FDA likely has scores of scientists on staff who can think intelligently about it, maybe collaborate with each other on its finer points, and arrive at a sensible answer.
Justice Elena Kagan
“As leading organizations that work on behalf of people across the country who face serious, acute and chronic illnesses, as well as many people who lack access to quality and affordable healthcare, we will continue to work to ensure that healthcare laws are implemented in ways that benefit the public health.”
The Supreme Court’s decision to overturn the Chevron doctrine will have a significant effect on nearly all federal agencies, including FDA and NIH, said Jon Retzlaff, chief policy officer for the American Association for Cancer Research.
“The ruling will very likely limit the ability of the Center for Tobacco Products at the FDA to regulate tobacco products, including e-cigarettes, in its current and ongoing efforts and approach to protecting public health, such as via CTP’s interpretation of the ‘appropriate for the protection of the public health’ standard,” Retzlaff said to The Cancer Letter. “For example, this ruling will potentially complicate CTP’s efforts to move forward with its proposed rule to prohibit menthol cigarettes and flavored cigars, as well as its future plan to reduce the nicotine content in cigarettes to limit their addictiveness.
“The fact that courts will now no longer need to defer to an executive agency’s expertise when determining the more detailed rules surrounding legislation that Congress has passed, will embolden the tobacco industry to influence the regulatory environment in ways that will very likely endanger public health.”
The ruling could have serious implications for oncology drug development, patients, and biomedical research, said Ryan Hohman, vice president of public affairs at Friends of Cancer Research.
“The decision has created uncertainty regarding FDA’s authority to interpret sometimes unclear statutory measures,” Hohman said to The Cancer Letter.
“This ruling could lead to challenges for both the FDA and the companies they oversee, resulting in increased legal disputes. While it may not directly impact FDA’s ability to approve drugs and devices, it introduces uncertainty that could destabilize the industry, and lead to delays in access to new therapies.”
Unpredictable alterations to the regulatory authority of federal health agencies could “fragment and disrupt” the delivery of cancer care across the U.S., said Eric Winer, board chair of the American Society of Clinical Oncology.
“The Supreme Court decisions overturning the longstanding role of administrative agencies upend the complex and interdependent framework on which the U.S. healthcare system is built by looking to judges rather than experts within federal agencies when implementing our country’s laws,” Winer said in a statement June 28.
“These decisions now call into question the Food and Drug Administration’s (FDA) authority over prescription drugs, the Centers for Medicare & Medicaid Services’ (CMS) ability to determine eligibility for critical public health insurance programs as well as essential physician and hospital payments, and many other federal agencies’ authority to implement important guardrails for people with cancer in this country.
“Deferring to judges and courts rather than expert administrative agencies such as FDA, CMS, and others, could harm people with cancer and the providers who care for them,” Winer said. “Furthermore, Congress and the courts cannot be expected to act with the speed and scope necessary to address every complex regulatory issue involved in administering health care in the U.S.
“ASCO will continue to analyze the impacts of this ruling and will do everything possible to protect patient access to high-quality, equitable cancer care.”
Experts: Loper decision can cut both ways
There is a potential upside to the ruling: The end of the Chevron doctrine could serve as a safeguard against future executive branch actions that may jeopardize public health—in the event that an anti-science and anti-regulation administration takes the reins in Washington.
“Chevron was actually a response to the Reagan-era Environmental Protection Agency, more narrowly defining its scope, environmental protection groups bringing litigation challenging the EPA’s statutory interpretation, and courts—including a pre-SCOTUS Ruth Bader Ginsburg—agreeing with the plaintiff’s interpretation of the law and not the agency’s,” Harvard’s Shachar said. “So, shifting away from agency deference to judicial interpretation could help access to care in a situation where the courts would be more sympathetic than the current administration.”
Leaders in healthcare and patient advocacy will need to be nimble in responding to the impending maelstrom of litigation, Georgetown’s Baron said.
“I think the other point, just to be crystal clear, is if a future Trump administration says we are going to unwind, change all these regulations under the Affordable Care Act, or even, certainly with respect to potentially other decisions in reproductive health care, you could see plaintiffs—consumer groups, patient groups, state attorneys general, others that are looking to defend access to health coverage and defend access to abortion care—they could have new points of attack to block those types of regulatory efforts,” Baron said.
“Just because you bring more litigation, doesn’t necessarily mean you win more cases.”
