• FDA layoffs have significantly reduced the staff of the Division of Drug Information (DDI), hindering drug safety monitoring.
• The termination of Risk Evaluation and Management Strategies (REMS) programs for certain drugs, without clear communication, has caused confusion among healthcare providers.
• Reduced capacity in the DDI may impair the FDA's ability to respond to new safety concerns, drug recalls, and other critical public health issues.

Recent staff reductions at the FDA, especially within the Division of Drug Information (DDI), have raised serious concerns about the agency's capacity to effectively monitor drug safety. These layoffs appear to be impacting various programs, including Risk Evaluation and Mitigation Strategies (REMS), leading to confusion among healthcare providers and potential risks to patient safety. The situation highlights the importance of robust post-market drug surveillance and raises questions about the FDA's ability to fulfill its mission of protecting public health.

• What: Layoffs at the FDA, particularly within the Division of Drug Information (DDI), have led to the termination of some REMS programs, reduced staff capacity for safety monitoring, and confusion among healthcare providers.
• Who: Key individuals include fired FDA employees, Brian Spoelhof (pharmacist and bioethicist), Marty Makary (new FDA commissioner), and patients potentially affected by the changes. Organizations involved include the FDA, drug manufacturers, and healthcare providers.
• When: The layoffs occurred on April 1. REMS programs for macitentan and ambrisentan ended around April 4. An email about the REMS program termination was sent on April 10.
• Where: The events are occurring within the US, impacting national drug safety monitoring programs and healthcare practices.

The FDA layoffs and their impact on drug safety monitoring raise significant concerns. The termination of REMS programs without clear communication creates confusion and potential risks for patients. The reduced capacity of the DDI may impair the FDA's ability to respond to emerging safety issues, drug recalls, and other public health emergencies. The long-term consequences could include increased adverse drug events, delayed identification of safety signals, and a diminished public trust in the FDA's ability to ensure drug safety.

There’s a handful of people desperately keeping the lights on.

Where we’re kind of struggling is how to find . . . just any information.

when you don’t have good postapproval monitoring, as this agency has not had, you discover things decades later.

Recent FDA layoffs are impacting drug safety monitoring, with potential consequences for patient safety. The reduction in DDI staff and termination of REMS programs have created confusion among healthcare providers and raised concerns about the FDA's ability to respond to emerging safety issues. While the new FDA commissioner has expressed interest in boosting safety monitoring, the immediate impact of the layoffs is concerning, and the long-term effects remain to be seen. Monitoring of drug safety and clear communication about program changes are crucial to ensure patient safety and public trust.