FDA Layoffs Disrupt Medical Device and Tobacco Product Reviews

Health regulators at the FDA are struggling to meet review deadlines for medical devices and tobacco products due to recent layoffs. Scientists report doubled workloads and canceled research projects, with high-profile applications like Philip Morris' IQOS facing lengthy delays.

The U.S. Food and Drug Administration is facing significant challenges in meeting mandated review deadlines for medical devices and tobacco products after recent layoffs under the Trump administration. Scientists involved in these projects told Reuters that the FDA is grappling with workforce reductions across health agencies, including 3,500 positions cut earlier this year.

FDA scientists noted that staff firings had doubled individual workloads, leading to shelved projects and oversight reductions. This has particularly impacted the Center for Tobacco Products, where high-profile applications, such as Philip Morris International's IQOS device, face extended delays beyond the 180-day legal review period.

With the assistance of the U.S. Department of Government Efficiency, led by Elon Musk, and ongoing buyout offers, the loss of personnel and expertise could result in longer review times, delayed market product entry, and increased risk of overlooked issues, experts and industry insiders warned.

(With inputs from agencies.)