Drugs

FDA Chief Counsel Post on Hold for Now

It’s been over two months since former Justice Department attorney Hilary Perkins was ousted (see earlier story) from her FDA chief counsel post after being on the job for two days, and the agency is still without its top lawyer. The position is now on hold until President Trump’s nominee for HHS general counsel, West Virginia state senator Mike Stuart, is confirmed by the U.S. Senate, according to HHS deputy general counsel Bob Fox Foster. Currently, Stuart’s nomination has been referred to the Senate Finance Committee.

Speaking at the Food and Drug Law Institute’s annual meeting 5/16, Foster said FDA’s chief counsel seat is being kept warm, and when Stuart comes onboard at HHS there will be a “great stack of resumes and colleagues to consider for that role,” he said. “But in the moment, nothing's getting missed. The commissioner is getting great legal advice from me and others in the Food and Drug Division.”

Perkins’ ouster made headlines in March when it was learned that her abrupt departure was orchestrated by Sen. Josh Hawley (R-MO), who objected to the former Justice Department lawyer’s new post because she defended FDA and the Biden Administration’s policy on the availability of abortion pills in a high-profile case, according to the Daily Wire. She also signed an earlier legal brief expressing support for president Biden’s Covid-19 vaccine mandates, Hawley said.

In his address to FDLI, Foster noted that FDA has not lost a single lawyer to HHS’ reduction-in-force efforts, although some have chosen to leave or retire voluntarily. He said it was important to HHS to ensure the consistency was there and the “bandwidth was not negatively impacted in any way.”

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