The first Trump administration was marked by mismanagement of the COVID-19 pandemic and politicization of public health agencies. In 2020, Donald Trump’s appointed HHS secretary demanded the right to review and change CDC’s weekly COVID-19 reports for health professionals. The administration reduced subsidies under the Affordable Care Act (ACA) and approved waivers instituting Medicaid work requirements in 13 states, both of which actions increased the number of uninsured Americans. Meanwhile, Trump’s appointments to the Supreme Court culminated in the reversal of Roe v. Wade.
With Trump’s return to the White House, the future of U.S. health policy is again in the spotlight. Concerningly, he has nominated Robert F. Kennedy Jr. (RFK Jr.) for HHS secretary, a position that oversees 10 public health agencies, including the CDC, FDA, and NIH. A few days later, he nominated Mehmet Oz, MD, to lead CMS. Both nominees have a long history of ignoring scientific evidence.
Often viewed as the world’s most influential anti-vaxxer, RFK Jr. recently threatened to get rid of FDA career scientists unless they ended the agency’s “aggressive suppression” of vitamins, raw milk, stem cells, and drugs like ivermectin and hydroxychloroquine. “Dr. Oz,” a TV personality, has been criticized for promoting baseless or incorrect medical advice on his show, including a green coffee extract “miracle” pill to lose weight.
While the president and his political appointees would wield enormous power and influence over the nation’s venerable scientific agencies, there are constitutional and institutional guardrails against the most extreme anti-science policies. Understanding these safeguards will be crucial to effectively challenge harmful policies. So, let’s review the authority that both the president and his appointees hold and the restraints on those powers.
Banning Vaccines or Water Fluoridation
RFK. Jr. has peddled conspiracy theories about vaccines, especially COVID-19 vaccines and measles-mumps-rubella (MMR) vaccines, which he has falsely linked to autism. Although RFK Jr. has said he does not plan to ban vaccines, the president-elect has not completely ruled out this idea. RFK Jr. has also stated that he seeks to end the fluoridation of water nationwide.
As powerful as the president and his HHS secretary are, they do not have the authority to ban vaccines or water fluoridation. Under the Constitution and our system of federalism, public health powers are reserved to the states. All 50 states and Washington D.C. have laws requiring a suite of vaccines for school attendance. Similarly, states and localities control decisions about adding fluoride to public water to promote dental health.
However, in determining which vaccines to include in the schedule of childhood immunizations, states rely on recommendations by CDC’s Advisory Committee on Immunization Practices (ACIP). ACIP members are nationally recognized experts in immunization science and serve staggered 4-year terms. ACIP members are appointed by the HHS secretary. A future secretary Kennedy, therefore, would be able to appoint virtually all ACIP members over the next 4 years, which could politically poison the well of objective scientific recommendations. RFK Jr. has also said he would mine vaccine data and publicly disclose what he regards as unsafe vaccines. It is possible he could cherry-pick data, further undermining public trust in ACIP recommendations.
Beyond appointing ACIP members and putting out misleading information about vaccine safety, RFK Jr. could seek to interfere with FDA decisions on vaccine approvals. Suppose a future secretary overrode career FDA scientists or decided to put on a warning label on a vaccine. That is fully within the secretary’s powers.
But there are guardrails. Decisions about drug and vaccine approvals are made at the FDA’s “center director” levels, which are currently not politically appointed. Career FDA scientists would likely resist political interference in their decisions, and they have civil service and whistle-blower protections. (Of note, Trump has previously tried to remove civil service protections for thousands of employees). Further, if the secretary overturned an FDA approval based on political preference and without scientific evidence, he could face a major legal challenge. Even a conservative Supreme Court is likely to think twice about going down the road of political interference in the FDA’s scientific evaluations.
Healthcare Access and Affordability
During his first term, Trump attempted to repeal and replace the ACA several times but failed to gather enough congressional support. While a new Trump administration could try again, it is more likely it will reduce affordable access to ACA plans.
Conservative proposals aim to significantly cut ACA subsidies, reduce Medicaid funding, and reintroduce risk pools to the insurance marketplace, raising costs for people with pre-existing conditions. If enacted, these changes could leave up to tens of millions without affordable coverage. Many of these actions would be open to the president, the HHS secretary, and the CMS administrator without congressional approval. But since the GOP holds both chambers of Congress, it is feasible that more extreme cuts could come with congressional approval.
Meanwhile, RFK Jr. is reportedly exploring a proposal to reduce the role played by the American Medical Association (AMA) in determining what Medicare pays for medical services, possibly shifting the determination to CMS. Besides leading to a major loss of revenue and influence for the AMA, upending the longstanding process for determining the medical billing code structure could affect Medicare reimbursement levels. If this leads to lower payments for medical services, fewer doctors may accept Medicare, reducing access and otherwise impacting care.
Political Appointments and Restructuring
The president wields tremendous influence over federal public health agencies, through appointments, restructuring of internal departments and agencies, and executive orders. The Trump administration may work with Congress to slash spending for key public health agencies (e.g., CDC, NIH, and FDA) and programs (Children’s Health Insurance Program, Medicaid, and possibly Medicare).
In addition to the loss of vital funding, public health agencies might suffer reorganization or loss of key functions. Project 2025, for example, has proposed splitting the CDC into two agencies, which could hinder the agency’s ability to prevent or mitigate the spread of disease. RFK Jr. has also pushed to eliminate the FDA’s Center for Food Safety and Applied Nutrition.
While control over the federal health workforce and key agency functions are held firmly by the president and HHS secretary, there are a few limits to plenary control. Political appointments often require Senate confirmation. Agencies must follow the Administrative Procedure Act, which requires a public notice-and-comment period for significant regulatory changes; this takes time and creates an evidentiary record that the agency may not totally ignore. Additionally, despite the overturning of Chevron deference to agencies, courts can review and block agency actions that are deemed arbitrary or capricious.
Overall, if confirmed, RFK Jr. would have a sizable influence on budget, priorities, and staffing — possibly remaking the federal health workforce with staff that distrust scientific research and evidence, and disempower career scientific experts.
Agency Orders and Control
Rescinding existing final rules and regulations requires going through the notice-and-comment process, as well as a justification for the policy change. Courts may well not allow a rule or regulation to be overturned purely for political reasons, especially if it goes against the weight of scientific evidence.
Such a battle could be seen around FDA approval of mifepristone — a pill used in a majority of abortion care in the U.S. Anti-abortion activists are pressuring Trump to restrict access to the drug. This year, the Supreme Court dismissed a challenge to the FDA’s original approval of mifepristone, but Trump has at times indicated an openness to revoking expanded access. Rescinding approval would invite intense litigation.
The Trump administration will have the opportunity to influence public health and safety through enforcement discretion as well. Conservatives have called on Trump to direct the Department of Justice (DOJ) to enforce a radical interpretation of the Comstock Act to target the mailing of mifepristone and threaten criminal penalties against providers to discourage treatment. Project 2025 further calls for reinstating an in-person abortion medication dispensing requirement, which would effectively end the telehealth provision of mifepristone, which the FDA allowed in 2021.
RFK Jr. also seeks to undermine the FDA’s schedule of safe pharmaceutical products to permit the use of alternative medicines. Approving psychedelic drugs for medical purposes, approving consumption of raw milk products, or green-lighting other untested or unsafe treatments would need to go through formal processes. However, the administration could still promote the use of these products through public recommendations or by directing the DOJ to stop enforcing rules that prevent companies from marketing unregulated and unproven health regimens.
Future Challenges
Robust U.S. institutions will protect the public from the most extreme health policies. Dedicated career public health professionals at HHS agencies will be a check on the secretary’s power and influence. And these scientists, at least currently, hold both civil service and whistleblower protections. State governments can prioritize science and reinforce health policies that advance the public’s health and safety. And even a highly conservative judiciary may serve as a check on federal actions that clearly overreach. The public health community will have to rely on these systems, processes, and guardrails to support health access, emergency preparedness, and the environment.
Lawrence O. Gostin, JD, LLD, is distinguished university professor, the highest academic rank at Georgetown University, where he directs the O’Neill Institute for National & Global Health Law. He is also the director of the World Health Organization Collaborating Center on National & Global Health Law, and the author of Public Health Law: Power, Duty, Restraint. Adi Radhakrishnan, JD, is a law fellow with the O’Neill Institute. Eric A. Friedman, JD, is Global Health Justice Scholar at the O’Neill Institute.
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Source link : https://www.medpagetoday.com/opinion/the-health-docket/113043
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Publish date : 2024-11-21 19:10:02
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