FDA Policy/General

FDA Protected From Firings During Shutdown: Makary

FDA commissioner Marty Makary has told agency employees that they are protected from planned mass workforce firings if a government shutdown goes into effect 10/1. “I want you to know that would not apply to the FDA,” Makary said in a 30-second video reported by Bloomberg Law that was sent to staff over the weekend. “I was able to ensure an exemption because we are in the business of public safety… The FDA is strong and it’s going to continue to be strong.”

The White House Office of Management and Budget (OMB) is instructing federal agencies to prepare reduction-in-force plans that could permanently eliminate jobs if a government shutdown occurs, according to a Politico report. Unlike past shutdowns, where most employees were temporarily furloughed and later reinstated, this directive would target programs that lose discretionary funding and don’t align with President Trump’s priorities. Essential services like Social Security, Medicare, veterans benefits, military operations, law enforcement, and air traffic control would continue.

The OMB move escalates the budget standoff with Democrats, who are blocking a House-passed stopgap bill as they push for broader negotiations, including on health care subsidies, ahead of the 9/30 budget deadline.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome