FDA Policy/General

Chief Scientist Tapped as Woodcock Replacement

FDA chief scientist Namandjé Bumpus has been selected to replace principal deputy commissioner Janet Woodcock when she retires early next year. In an online “X” announcement, FDA commissioner Robert Califf called Bumpus a “powerhouse scientist and leader, who will continue to advance the agency’s critical public health initiatives using cutting-edge regulatory science as a North Star… There are many analogous situations that point out how hard it is to step into a role held by a legendary leader, but I am confident Dr. Bumpus is up for it!”

Earlier this month, Woodcock announced her retirement after 37 years at the agency (see earlier story). She spent over two decades as CDER director until the Covid-19 pandemic saw her move to the government’s “Operation Warp Speed” response in early 2020. In this capacity, she supported the development, evaluation, and availability of treatments such as monoclonal antibodies and antiviral drugs for patients with Covid-19. Upon Califf’s 2/2022 return to the agency, she moved into her current second-in-command position.

Bumpus was named chief scientist 6/2022 after serving as E.K. Marshall and Thomas H. Maren Professor and chair of the Department of Pharmacology and Molecular Sciences at Johns Hopkins University School of Medicine. Previously, she was associate dean for basic at the same school. “Bumpus’ research has focused on drug metabolism, pharmacogenetics, bioanalytical chemistry, and infectious disease pharmacology,” her bio says on the agency’s Web site.

Bumpus received her doctorate in pharmacology at the University of Michigan in 2007 and completed a postdoctoral fellowship in molecular and experimental medicine at The Scripps Research Institute in La Jolla, CA in 2010.

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