FDA Policy/General

Biden Nearing His FDA Commissioner Pick

The Biden Administration is nearing its choice of a nominee for FDA commissioner. Addressing reporters on 10/5, president Biden was asked whether he had chosen someone for the agency‘s top job. “We’ll be talking about that in a little bit,” he responded.

The Biden Administration reportedly has ruled out nominating FDA acting commissioner Janet Woodcock for the agency’s top post due to lawmakers’ objections. Based on government regulations, she can remain in her current acting role until mid-November. However, if a different nominee is named, then she can remain in her temporary post until the confirmation process is completed. Senator Joe Manchin (D-WV), who is a needed vote for Senate confirmation, has been on record opposing Woodcock due to concerns about how liberally FDA approved opioids when Woodcock was CDER director. There is also push back from lawmakers concerned about maintaining the status quo following the recent controversial accelerated approval of Biogen’s Alzheimer’s drug.

A Politico report notes that one name on the short list is Dana-Farber Cancer Institute CEO Laurie Glimcher. However, Glimcher told Endpoints News in an email: “I am committed to Dana-Farber Cancer institute and our ongoing progress against cancer, and I am not a candidate to be the next commissioner of the FDA.” Other names that continue to be mentioned for the nomination include former FDA principal deputy commissioner Joshua Sharfstein (Obama Administration) and Biotechnology Innovation Organization CEO Michelle McMurry-Heath.

Regardless who is selected, the next FDA commissioner will have a full plate in leading FDA out of the pandemic. Employee morale has taken a hit as the agency has navigated an increase in submissions, adjusted to working virtually, transitioned to more innovative ways to regulate product manufacturers in lieu of physical inspections, and struggled to maintain its independence as the last two administrations have sought unprecedented political overreach.

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