Article Summary:
This week, the FDA made several notable regulatory moves. They officially revoked a controversial rule to govern laboratory-developed tests (LDTs), after a court ruled the agency had overstepped its authority. Meanwhile, the recently fired CDC director, Susan Wen Monarez, warned lawmakers that the public health system under the leadership of HHS Secretary Robert Kennedy Jr. and his anti-vaccine advisors is headed in a “very dangerous place.”
Monarez’s testimony came a day before the CDC’s immunization advisory panel met to discuss weakening COVID-19 vaccine recommendations, including advising that everyone consult their doctor before getting vaccinated. The panel also recommended delaying other childhood vaccines until age 4, though they did not align this with the Vaccines For Children program.
In other FDA news, the agency proposed removing the color additive Orange B from food casings, saying it is no longer used. Former Enzyme CEO Jared Seehafer also joined the FDA as a senior advisor. The agency set user fee rates for certain priority review vouchers and approved an injectable version of Merck’s cancer drug Keytruda.
Looking ahead, the FDA will host several public workshops – one on developing pediatric therapeutics, and another on regulatory oversight of AI in generic drug development. They will also present on how the Generic Drug User Fee Amendments have affected generic approvals. Additionally, the FDA issued consumer warnings about unauthorized infant monitors and blood pressure devices, and reclassified certain hepatitis B tests.