FDA Policy/General

Senator Scott Urges FDA to Fill Vacancies

Senator Rick Scott (R-FL) is urging FDA to fill vacant management posts at CDER and CBER because, he says, “FDA is too important an agency, and too large and complex an organization, for it to operate under temporary leadership.” In a 3/22 letter to FDA commissioner Robert Califf, Scott noted that CDER has 48 vacant positions and 47 acting heads, while CBER has six vacant positions and 11 acting heads.

“Understaffed critical components slows the speed of drug, biologic, and vaccine approvals and only add to agency inefficiencies,” Scott wrote in the letter. “Last year’s departure of the director and the deputy director of the Office of Vaccine Research and Review [OVRR} adds to my concerns that the agency’s management is woefully unprepared to get ahead of the pandemic and prevent a backlog of new drug and generic application review. This is a critical time to finalize vaccine development and approval.”

The departure of senior managers in the vaccine office “does not help the FDA’s mission or its role in educating the public on vaccine efficiency and importance,” Scott wrote. ”The acting director replacement, while a capable cancer doctor, lacks the necessary vaccine expertise and experience that the prior directors possessed.” Presumably, this was a dig at CBER director Peter Marks, who took over as OVRR acting director in the wake of director Marion Gruber and deputy Phillip Krause announcing their simultaneous departures in 9/2021 (see earlier story).

Ironically and earlier this month, the American Medical Association (AMA) bestowed its Award for Outstanding Government Service on Marks and recognized his leadership during the Covid-19 pandemic. According to his online bio, Marks obtained his medical degree at New York University and completed an internal medicine residency and hematology/medical oncology fellowship at Brigham and Women’s Hospital in Boston, where he subsequently joined the attending staff as a clinician-scientist and eventually served as hematology clinical director.

After a short stint with industry, Marks joined Yale University where he led the Adult Leukemia Service and served as chief clinical officer of Smilow Cancer Hospital. He joined the FDA in 2012 as CBER deputy Center director and became Center director in 2016. He is board certified in internal medicine, hematology and medical oncology.

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