FDA Policy/General

Could Be ‘Weeks’ Before FDA Chief is Named: CNN

CNN reports that the Biden administration has considered several people in its search for a permanent FDA commissioner who can win Senate approval and has come up short. “Two officials said it could be ‘weeks’ before Biden settles on anyone,” the online story says.

The network reports the White House has considered acting commissioner Janet Woodcock, former Obama administration officials, and outside public health experts. “We’re working on that very hard to make sure we can get it passed,” Biden told reporters when asked why no commissioner has been named.

White House press secretary Jen Psaki said filling the position is a “priority,” with Biden waiting to find “exactly the right person. He wants to name someone who is qualified, who’s ready to lead FDA. It is a priority for him. He’s also not going to take a step to put forward a nominee before he’s found exactly the right person. I will note that it is a place that is filled with talented experienced scientists, data experts, career staff who are certainly running FDA effectively.”

The report indicates that it is likely Woodcock could not win confirmation, given the pushback from needed votes such as Sen. Joe Manchin (D-WV), who has raised concerns about how liberally FDA approved opioids when Woodcock was CDER director.

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