FDA Policy/General

Trump Order Stifles Union Representation at FDA

In a move presumably to make it easier to terminate federal employees, president Trump late last week signed an executive order to remove organized union representation from the majority of government agencies, including FDA and other HHS health agencies. Government watchers are predicting that the order will vigorously be challenged in federal court.

The order comes as the administration is beginning to announce the next round of employee terminations. Last week, HHS said (see earlier story) FDA will lose about 3,500 (18%) of its 19,000 full-time employees under a just-announced HHS restructuring in response to the president’s Department of Government Efficiency (DOGE) Workforce Optimization Initiative executive order. This is in addition to the 1,000 agency probationary employees who were cut last month from its rolls.

A fact sheet announcing the policy document says that Trump cited a rarely used provision of the 1978 Civil Service Reform Act allowing the president to exclude agencies and their subcomponents from collective bargaining rules if the rules “cannot be applied to that agency or subdivision in a manner consistent with national security requirements,” according to Government Executive. University of Maryland School of Public Policy former professor Don Kettl told the news outlet that the Civil Service Reform Act’s national security exemption does not stretch far enough to cover the agencies cited by the Trump administration.

“The president has power to change the conditions under which union representation occurs and to negotiate new contracts when existing ones expire,” he said. “But the president cannot simply wipe away existing agreements.”

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