FDA Policy/General

Six Former FDA Heads Urge Biden to Pick Commissioner

Six former FDA commissioners are urging President Biden to prioritize the nomination and confirmation of an FDA commissioner. In a 3/9 letter, the group expressed concern about the Trump Administration’s interference with the agency’s independence and lack of support to carry out essential science-based regulatory activities during the Covid-19 public health emergency. “To continue to advance the agency’s mission, and promote its independent role, we urge you to prioritize securing [FDA’s] leadership team,” they wrote. The letter was signed by Robert Califf, Scott Gottlieb, Margaret Hamburg, Jane Henney, Mark McClellan, and Andrew von Eschenbach.

The delay in nominating a commissioner has been noteworthy among FDA observers (see earlier story), with many acknowledging that two earlier prospects have likely fallen out of consideration — acting commissioner Janet Woodcock and former FDA principal deputy commissioner Joshua Sharfstein. Some lawmakers reportedly are not rallying behind Woodcock and her more than 25 years leading the drug Center at FDA due to her presiding over one of the worst regulatory agency failures in U.S. history, the opioid crisis, among other issues. The pivot away from Sharfstein follows criticism from patient advocacy organizations and industry about a lack of experience. Critics are urging a strong leader to repair the agency’s morale and credibility after political interference reached unprecedented levels during the Trump Administration.

The six former commissioners also seem to be leaning toward a Woodcock nomination, acknowledging her willingness to take on the acting commissioner role and her commitment to FDA’s scientific mission and its career staff. “Across Democratic and Republican administrations, we have worked closely with Dr. Woodcock across a range of critical issues,” they wrote. “Dr. Woodcock is a highly effective advocate for advancing the FDA’s mission – a role she has continued from her first day as acting commissioner.”

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