Physician and pharmacist organizations challenged Health Secretary Robert F. Kennedy Jr.'s decision Thursday to terminate Emergency Use Authorizations for COVID-19 drugs and devices, warning of disrupted patient access. The Department of Health and Human Services announced the change earlier this week.
The decision affects the antivirals Paxlovid, made by Pfizer, and Lagevrio, made by Merck, along with certain diagnostic devices still operating under emergency clearances. Paxlovid received full FDA approval in 2023 for high-risk adults, but Lagevrio remained available only under its EUA, meaning its termination could remove the drug from the US market entirely.
The Infectious Diseases Society of America and the American Pharmacists Association said the abrupt withdrawal risked confusion among clinicians and patients heading into the summer respiratory season. Both groups called on HHS to clarify transition timelines and preserve access for immunocompromised patients who rely on early antiviral treatment.
A Pfizer spokesperson said Paxlovid remained available under its existing FDA approval and that the company was reviewing the department's guidance. Merck said it was assessing the impact on Lagevrio and would engage with regulators.
Public health researchers at Johns Hopkins University warned that the change fit a broader pattern of rolling back pandemic-era measures. Kennedy has repeatedly criticized emergency authorizations as overused, arguing that standard FDA review processes should govern drug availability. Critics said the timing left providers with little notice to adjust prescribing practices.