Lawsuits Likely as Federal Authorities Roll Back Longstanding Vaccine Guidelines

In a recent interview with Pharmaceutical Executive, Ron Lanton, partner, Lanton Law, discussed the unprecedented legal and policy challenges emerging from recent changes to federal vaccine recommendations under Robert F. Kennedy Jr’s leadership at HHS. Lanton explained that while federal law has long guaranteed access to vaccines through programs such as the Affordable Care Act and the Vaccines for Children initiative, recent shifts raise complex questions about coverage, regulatory authority, and the future of vaccine policy in the United States.

Pharmaceutical Executive: From a legal perspective, what challenges and precedents exist when federal health authorities, such as HHS under Robert F. Kennedy Jr., change or limit vaccine recommendations that were previously standard?

Ron Lanton: Under the Affordable Care Act, all insurance plans—including Medicare, Medicaid, and private insurance—are required to fully cover vaccines recommended by the Advisory Committee on Immunization Practices (ACIP). Since 1994, the Vaccines for Children program has also provided ACIP-recommended and CDC-approved vaccines free of charge to low-income children. Normally, this framework would help safeguard access. However, if ACIP itself has been dismantled or stripped of authority—as has been reported under RFK Jr.—that protection may no longer hold.

Complicating matters further, these policy changes occurred while RFK Jr. was effectively the sole decision-maker on vaccine policy, since the new CDC director had not yet been sworn in. This makes the situation unprecedented from a legal standpoint. Reversing these changes will likely require numerous lawsuits across multiple fronts. It’s an issue every stakeholder in the healthcare supply chain needs to monitor closely.

Full Interview Summary: From a legal standpoint, recent shifts in federal vaccine policy under RFK Jr. raise unprecedented challenges. Historically, vaccine access in the U.S. has been anchored by recommendations from the Advisory Committee on Immunization Practices (ACIP). Since 1994, ACIP-recommended vaccines have been required to be fully covered by Medicare, Medicaid, and private insurance under the Affordable Care Act (ACA). Similarly, the Vaccines for Children program has ensured free access to ACIP- and CDC-approved vaccines for low-income children. These frameworks were designed to protect universal access regardless of political changes.

However, if ACIP’s role has already been weakened or “gutted” under RFK Jr.’s tenure, the system faces a novel legal and regulatory crisis. Because the new CDC director only recently assumed office, responsibility for these changes appears to rest solely with RFK Jr. This creates an unprecedented situation in which longstanding vaccine recommendations were altered or limited at the federal level, potentially undermining established protections under the ACA and other federal programs. Reversing such changes will almost certainly require extensive litigation across multiple fronts, involving stakeholders throughout the healthcare and insurance supply chains.

Another open question is how these lawsuits might affect the broader regulatory environment for vaccines. While the CDC shapes recommendations, vaccine approvals and emergency use authorizations fall under the FDA. At present, the FDA has not signaled a policy shift, but if it were to align with restrictive approaches, the impact would be transformative. Such coordination from the executive branch could reshape not only access to existing vaccines but also the approval pathway for future ones. Stakeholders should therefore prepare for a protracted legal battle and remain alert to possible ripple effects on both public health policy and the vaccine market.