As public health advocates and politicians who support vaccines and other long-standing public health interventions face the possibility of conspiracy theorist Robert F. Kennedy Jr. leading the Department of Health and Human Services, they may find an unlikely source of assistance to block some of Kennedy’s most unsupported ideas: the Supreme Court.
In mid-2024, the Supreme Court’s conservative supermajority overturned its 40-year-old finding in Chevron v. Natural Resources Defense Council, a precedent that had largely given specific government agencies (and experts working for them) the authority to interpret rules, regulations and guidance they were charged with implementing. In doing so, the court shifted the power to approve or deny changes in the regulatory landscape away from the agencies — ones like the Food and Drug Administration, Federal Trade Commission, and Centers for Medicare and Medicaid Services — and toward the judiciary.
That may make it harder for Kennedy, known for his strident opposition to vaccines and his promotion of false or exaggerated notions related to medicine and health, to easily change how the many subagencies and regulatory bodies within HHS treat vaccines, prescription drugs and scientific research.
“The end of Chevron deference does offer an opportunity to challenge bad regulations,” said Dr. Reshma Ramachandran, a physician and associate professor at the Yale School of Medicine, in reference to the legal precedent. “And we expect there’s a high likelihood in the incoming administration there’s going to be regulations that are very concerning and antithetical to public health. They can’t just rely on the fact that they will be able to interpret the statute however they like.”
Public health advocates are alarmed by President-elect Donald Trump’s choice of Kennedy to lead HHS due to his fringe views on health issues.
Kennedy has suggested that “there’s no vaccine that is safe and effective,” HIV may not be the cause of AIDS, chemicals in the environment could be causing gender dysphoria in children, antidepressants may be linked to mass shootings, and COVID-19 could be “ethnically targeted … to attack Caucasians and Black people” while largely sparing people who are “Ashkenazi Jews and Chinese.” There is no evidence to back up any of these claims.
How these views inform actions he might take at HHS is yet unknown. But, if he is successfully confirmed by the Senate, Kennedy could direct the agency to issue new rules, regulations and guidance governing everything from vaccines and regulatory standards to authorizations for prescription drugs and medical devices.
That is, unless the recent Supreme Court ruling on Chevron deference throws a wrench in the works.
The precedent had previously created a two-step process by which courts judged the appropriateness of government agencies’ interpretations of their statutory authority to issue regulations. It did not provide a universal deference, but a limited deference to these agency interpretations of often vague or ambiguous legislative grants of authority. So the agencies had a lot of leeway in issuing regulations and what they were allowed to do, but the courts were allowed to double-check that those interpretations were backed up by laws passed in Congress.
But with the case Loper Bright Enterprises v. Raimondo, the Supreme Court’s six conservatives reversed that, overruling Chevron deference and stating that courts would now “exercise their independent judgment in deciding whether an agency has acted within its statutory authority,” as courts had the “special competence” to provide answers on “statutory ambiguities.” Agency interpretations may now “persuade” courts, but courts no longer owe them any kind of deference.
In short, the courts have more power to approve or reject regulatory decisions made by agencies when the law is ambiguous about an agency’s regulatory authority.
Public health advocates argue that courts cannot be the best judges of the interpretations needed to regulate highly technical aspects of science and medicine because they lack the expertise of the scientists, doctors and researchers who make these decisions.
Liberal Justice Elena Kagan made this exact point in her dissent, noting that the FDA, which is governed by HHS, has to decide what constitutes a “protein” for certain regulatory actions.
“When does an alpha amino acid polymer qualify as such a ‘protein’? Must it have a specific, defined sequence of amino acids?” Kagan wrote, citing a 2020 case that dealt with this exact question.
These seemingly minute decisions can have significant impacts for pharmaceutical and medical device companies in determining how their products are regulated, but the new uncertainty makes enforcing regulation much riskier: Without deference for their rulemaking decisions, health and science agencies are likely to face far more litigation than before.
In mid-2024, the Supreme Court’s conservative supermajority overturned a 40-year-old precedent that provided significant deference to agencies in their interpretations of statutes granting them authority to issue regulations.
Anna Moneymaker via Getty Images
“Since Chevron has fallen, agencies are much more cautious in putting forward rules and regulations,” Ramachandran said.
And while this may be a hindrance to science-based public health rules, it could also act as a brake on any attempt by Kennedy to change how HHS treats vaccines, prescription drugs or other public health measures.
On vaccines, it would be very difficult, if not impossible, for Kennedy to revoke an authorization for a vaccine. He has said he won’t do that, but if he did, it would trigger a fierce fight within HHS and litigation in the courts.
He could, alternatively, try to issue new regulations or guidance related to vaccines — whether for future vaccine approval, coverage of vaccines under Medicare and Medicaid, labeling related to alleged vaccine harms, or guidance for medical professionals on vaccine distribution.
“He could say we’re going to revise these regulations now and go through the whole rulemaking process to do that,” Ramachandran said.
The same goes for regulatory approvals for drugs, including those that Kennedy has said were suppressed by the government — like hydroxychloroquine, ivermectin and psychedelics. He could change what uses these drugs are approved for or grant approval for drugs like the psychedelic MDMA, which was just rejected by the FDA in August.
But all of these things would face bigger hurdles in the courts with the end of Chevron deference. This is particularly true for long-established regulatory actions like vaccine approvals, or standards of guidance that have significant agency and court precedents backing them up, Ramachandran said.
Examples already abound where HHS regulations, guidance and pricing for services covered by Medicare and Medicaid are being challenged under the new standard.
In a lawsuit filed in July, Texas cited the Loper Bright decision in its challenge to HHS rules requiring certain health care providers to dispense contraceptives to minors without parental consent.
Florida Attorney General Ashley Moody (R) brought suit with Catholic doctors and hospitals in May to challenge HHS nondiscrimination rules that applied to sexual orientation and gender identity. Courts in Texas and Mississippi cited the Loper Bright case when they blocked the rules from going into effect.
On Nov. 5, the Supreme Court heard arguments in a case brought by hospitals that challenges a new HHS rule governing compensation to hospitals that see a large number of low-income patients — known as disproportionate-share hospital payments — for not paying them enough. Previous attempts to challenge the HHS rule failed in lower courts under the old Chevron deference standard, but now may succeed thanks to the high court’s decision in the Loper Bright case.
HHS is also the subject of a lawsuit that Texas filed prior to the reversal of the Chevron decision, arguing that agency guidance to hospitals stating that they can provide emergency abortion care, even in states with strict abortion bans, should not be afforded deference under the precedent. The Supreme Court temporarily allowed emergency abortionsto be performed in Idaho in a 6-3 decision issued back in June. The case out of Texas tackles the same issue, but is now continuing after the Loper Bright decision. With Chevron deference now gone, the emergency abortion guidance could face an even harder time in the courts.
Kennedy, pictured here in 2008, has long been a critic of vaccines, embracing discredited scientific theories about their dangers.
Brendan Hoffman via Getty Images
The same is likely to be true of any new rule or guidance that Kennedy would approve on vaccines or prescription drugs. That includes any labeling requirements involving warnings or other consumer information.
Lawsuits over these changes could come from any number of sources — vaccine makers, hospitals, doctors or public health advocates. But the end of Chevron deference places power in the hands of the judges who hear these cases, stoking fears that partisan or ideological opinions may outweigh scientific ones.
“People who still have faith in an ideal functioning judiciary will hope that a judge discerning the text and the purpose of a statute that governs HHS can independently evaluate whether an action taken by RFK Jr. really is in line with what the statute says,” said Andrew Twinamatsiko, a director of the Center for Health Policy and the Law at the O’Neill Institute in Washington.
Increasingly ideological or partisan opinions from Trump-appointed judges, particularly concentrated in regional arenas like the 5th U.S. Circuit Court of Appeals, may undermine that faith. For example, a decision by U.S. District Judge Matthew Kacsmaryk removing both new and long-standing approvals for the use of the drug mifepristone to perform abortions ignored actual scientific research, instead relying on a blog run by an anti-abortion organization as evidence. The Supreme Court rejected Kacsmaryk’s decision when it found that the anti-abortion groups bringing the case did not have legal standing to sue. Three GOP-led states, however, are now pursuing a similar lawsuit in the lower courts. This case brought the public’s attention to the issue of judge shopping, and the machinations carried out by litigants seeking a particular outcome to make sure their case ends up in front of a sympathetic judge.
“When you have a decision RFK has made that you might not like, you might not want to go to the 5th Circuit,” Twinamatsiko said.
While that may be true for public health advocates and companies with an interest in protecting science-based vaccine rules and regulations, other interests may find the 5th Circuit a good venue for post-Chevron regulatory challenges for some of Kennedy’s positions that align with public health.
Kennedy isn’t a conservative. He’s a former Democrat with diagonal views running across the plane of ideologies, from liberal to libertarian to pure conspiratorial.
His thoughts on chemical pollution, synthetic food ingredients and corporate influence over food and drug regulators align with those of liberals. But any efforts to regulate food additives like synthetic dyes would almost certainly face legal challenges from the food, agriculture and chemical industries under the post-Chevron rules.
Stopping vast changes to the regulatory landscape is what the Supreme Court’s conservatives had in mind when they ended the deference that the Chevron ruling provided agencies in the past.
During arguments in the Loper Bright case, Justice Brett Kavanaugh said that Chevron deference “ushers in shocks to the system every four or eight years when a new administration comes in.” Ending agency deference was meant to prevent such significant changes.
That could very well trip up Kennedy’s plans for vast changes to the entire regulatory framework for public health policy. And it will take not four years, but barely a year for this shock to the system to begin playing out.
