Commentary
Video
Author(s):
Ron Lanton, partner, Lanton Law, warns that ongoing lawsuits targeting vaccine policy could create ripple effects across FDA decision-making and reshape how future emergency use authorizations are granted.
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: How might lawsuits like this impact the regulatory environment for vaccine approvals and emergency use authorizations in the future?
Ron Lanton: Vaccine approvals and emergency use authorizations are handled by the FDA, not the CDC, so any lawsuits would focus on how broader vaccine policy affects public health. If the FDA were to adopt similar policies in the future, additional legal challenges would almost certainly follow. We haven’t seen that yet, but that doesn’t mean it couldn’t happen. The longer this plays out, the more coordinated the messaging from the executive branch appears to be on vaccine issues. If the FDA ultimately moves in that same direction, it would be a real game changer.
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.
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