FDA Policy/General

FDA Resisting Civil Service Executive Order: Report

In an online story, Politico reports that many senior officials within FDA are expressing alarm about a 10/21 Executive Order issued by President Trump that would make it easier to fire federal employees who have Civil Service protection. “There’s a legitimately palpable fear this could be wielded as a weapon to nix everyone,” an anonymous FDA official told Politico. “They see this as an opportunity to round up all the scientists who have been perceived to have been causing an obstruction.”

In response to questions from Politico, an FDA spokesperson said that agency continues to evaluate the Executive Order to determine appropriate next steps. After the publication of its post, the spokesperson described the characterization of agency internal discussions around the order as “patently false.”

Officials in HHS said health agencies are particularly worried about the fallout from Trump’s order because their efforts to combat the Covid-19 pandemic have often conflicted with Trump’s efforts to downplay the threat and swiftly reopen the economy, leading to what Politico describes as a series of high-profile clashes over public health guidance, key economic decision, and even the true severity of the crisis.

“FDA is viewed as particularly vulnerable,” the post says, “given its heavy reliance on career scientists across a range of regulatory areas and its recent battles with top Trump aides over standards for coronavirus vaccines.”

The article says a particular concern for FDA is a quirk in its hiring practices through which over the last few years it has reclassified dozens of career scientists under a special authority created by Congress that allows it to pay them higher salaries to retain top talent. That means the scientists may no longer be deemed part of the government’s senior executive service and thus vulnerable to the Executive Order, it says.

“You’ve got folks who are senior, committed, world-class scientists,” the anonymous FDA source told Politico. “All of whom, in some way, directly or indirectly, have conflicted with the administration.”

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

Read more

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