The US Food and Drug Administration (FDA) has laid off significant staff from its Division of Drug Information (DDI), which tracks drug safety. The cuts, part of a larger reduction in force announced in April, have resulted in the loss of between 75% to 90% of the DDI’s roughly 50-person staff.
Fired employees claim that the remaining staff are struggling to keep up with inquiries and lack the capacity to update databases such as the REMS program registry. The REMS program is an early-warning system for potential problems, but its data collection has often led to recalls.
The FDA oversees REMS programs, which require doctors to inform patients who could become pregnant about the risk from certain drugs, advise them on contraception plans, and make sure that patients are not pregnant before writing a prescription. However, some manufacturers have discontinued their REMS programs for specific drugs without notifying the FDA or the public.
Brian Spoelhof, a pharmacist and bioethicist, expressed concerns about the impact of these cuts on patient safety. He noted that doctors who treat pulmonary arterial hypertension will continue to exercise due diligence when prescribing macitentan and ambrisentan, but he worries that less experienced trainee physicians could write prescriptions in error.
The new FDA commissioner, Marty Makary, has stated his interest in boosting safety monitoring. However, the laid-off staff say the DDI conducted exactly such safety monitoring before being let go. The lack of transparency and clear communication about which restrictions on prescribers are being enforced is causing anxiety among healthcare providers.
As a result of the REMS program cuts, some patients may face barriers to access for certain medications. For example, the schizophrenia drug clozapine was terminated after an advisory committee called it overly burdensome for patients. Similarly, providers of reproductive health care have argued in court that programs regulating mifepristone raise barriers to timely abortion care.
The HHS has not responded to inquiries about whether MedWatch, a mechanism for reporting adverse events caused by drugs or raising concerns about contamination, is still operational. The lack of clear information and transparency is causing concern among healthcare providers and patients alike.
Source: https://cen.acs.org/safety/drug-safety/FDA-job-cuts-hinder-drug/103/web/2025/05