FDA struggles to meet deadlines after personnel layoffs - Reuters

Investing.com -- U.S. health regulators who oversee the safety and efficacy of medical devices and tobacco products are grappling with Congress-mandated deadlines due to recent layoffs by the Trump administration, according to Reuters, citing three scientists involved in the projects. The scientists, who asked to remain anonymous, work at the U.S. Food and Drug Administration (FDA) and have seen their workload increase as they now handle approximately double the number of new product applications for review.

The layoffs have resulted in some work being shelved, including oversight of other reviewers and providing early feedback on planned product applications before they are submitted for approval review. A scientist at the FDA’s Center for Tobacco Products reported that the center had postponed initiating new applications while staff worked on existing submissions. Some of these submissions are required by U.S. law to be reviewed within 180 days. The scientist stated that meeting this deadline is unlikely.

The U.S. Department of Government Efficiency, led by billionaire Elon Musk, dismissed around 1,000 probationary FDA employees last month, primarily from the agency’s centers for tobacco, food, and medical devices. Some of these employees were later rehired. The exact number of staff fired is uncertain. The FDA had a staff of over 20,000 earlier this year.

Harvard Medical School professor Ameet Sarpatwari warned that the FDA’s loss of personnel and institutional experience could lead to longer review times, potentially delaying product launches, or shorter review times, which could increase the risk of overlooking potential issues.

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