Biologics

CBER’s Marks Takes Over Vaccine Review Office

In the wake of two senior FDA vaccine officials leaving the agency (see earlier story) during the next month, CBER director Peter Marks has announced he will immediately serve as Office of Vaccines Research and Review (OVRR) acting director. Marks is replacing OVRR director Marion Gruber, who is retiring 10/31. Her deputy, Philip Krause, will be leaving in November. Gruber has been at FDA for 32 years, whereas Krause has been there for about 11 years.

Gruber and Krause reportedly are frustrated with the Biden Administration’s disjointed process for implementing its Covid-19 vaccine booster plan. Earlier this month, they joined outside researchers (see story) to argue against requiring Covid-19 booster shots until data can show a necessary benefit. Writing in a 9/13 Lancet viewpoint article, the FDAers and researchers say current evidence does not show a need for boosters for the general population because efficacy against severe disease remains high.

In a move to quell concerns, an 8/31 email to CBER staff from acting FDA commissioner Janet Woodcock said: “I am confident in the team that will remain in place under Peter’s [CBER director Peter Marks] leadership. We have put together a plan that will allow us to continue prioritizing science, while meeting timelines that are important to ensuring the end of the devastating pandemic... These are difficult time, requiring extraordinary effort, and I want to take the opportunity to once again thank you for your perseverance and dedication. The issues are complex and the days are long, bur please know the work you all have done to date and will continue to do in the days, weeks and months ahead, will hopefully one day allow us to fully put Covid-19 behind us and better prepare us for future challenges.”

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