Article Summary:
This week, the FDA has continued its work despite the ongoing government shutdown, publishing two new guidance documents and promoting several acting leaders to permanent roles. However, the shutdown has caused some issues, with some FDA staff reporting payroll problems and the agency considering another overhaul of its inspection program.
The government shutdown has resulted in some FDA staff not receiving their full paychecks on time, which the Department of Health and Human Services attributed to a “glitch in the furlough system.” Despite this, the FDA has managed to publish two new final guidance documents, one on expanded access to investigational drugs and another on clinical outcome assessments.
The FDA is also reportedly planning to revamp its inspection program, moving inspection staff into more generalist roles and undoing the agency’s previous efforts to specialize its investigators. Additionally, three acting FDA leaders have been promoted to permanent roles, including the chief scientist, the associate commissioner for inspections, and the director of the Center for Veterinary Medicine.
In other news, the Senate Health, Education, Labor, and Pensions Committee will hold a hearing next week on delivering cures to patients and maintaining US competitiveness in biotech. The FDA also approved several new drugs this week, including treatments for acute myeloid leukemia, multiple myeloma, and menopausal hot flashes. Finally, a health tech firm, Ōura, plans to seek FDA clearance for a blood pressure feature on its smart ring devices.