Drugs

2 FDA Officials Part of Wrongful Termination Lawsuit

Two former FDA officials are part of a group of seven former HHS employees who have filed a class-action wrongful termination lawsuit alleging the federal government knowingly used flawed and inaccurate personnel records during a controversial reduction-in-force (RIF) mass termination effort back in April. Former FDA chief information officer Vid Desai and FDA Office of Digital Transformation head Shawn Chenault are named in the lawsuit that seeks undetermined monetary damages and a declaratory judgment that the government used “inaccurate and incomplete data” and violated the Privacy Act in connection with the RIFs.

The lawsuit notes that the RIF process quickly drew scrutiny after employees began receiving termination notices riddled with errors — including incorrect performance ratings, inaccurate office names, and misleading information about which divisions were being eliminated. According to the lawsuit, performance ratings — a critical factor in determining who should be laid off — were frequently misstated. Some workers were assigned seemingly arbitrary codes that affected their eligibility for severance and temporary healthcare coverage, while others were told their entire office was being disbanded, even though it remained active.

“These errors are not just bureaucratic slip-ups — they impact people’s livelihoods, health coverage, and long-term careers,” said Civil Service Law Center lead attorney for the plaintiffs Clayton Bailey. “Because the decision-makers at these agencies were working with such flawed data, they barely knew who they were cutting. These employees suffered the consequences.”

The RIFs were set to take effect this week, but an appeals court late last week upheld a lower court ruling that froze the layoffs across FDA and other major federal agencies. The Trump administration has asked for a Supreme Court review while many of the former employees remain on administrative leave.

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