FDA Policy/General

FDA/HHS Play Musical Chairs with Chief Counsel Post

HHS has overridden FDA commissioner Stephen Hahn’s choice of who will temporarily lead the Office of Chief Counsel after chief counsel Stacy Cline Amin stepped down 1/11 (see earlier story). Hahn had announced that agency career lawyer and principal deputy chief counsel Mark Raza would serve as acting chief counsel. But in an apparent rebuke of Hahn, HHS announced late in the same day that Trump Administration appointee and HHS deputy general counsel James Lawrence will instead serve as the new chief counsel at FDA.

The chief counsel post change, which is likely to change again with the incoming Biden Administration taking control next week, shows the dysfunctional relationship FDA and HHS are currently operating under. This past November, Hahn was said to be on thin ice with the president and HHS secretary Alex Azar after Pfizer’s earlier announcement of promising Covid-19 vaccine data (see earlier story). The Trump Administration has fired several senior officials at various departments in the wake of the presidential election for a lack of loyalty, and Hahn had already irked both Trump and Azar earlier over the agency’s expanded requirements for safety information for ongoing vaccine trials that they believed delayed any vaccine from gaining approval before the election.

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