Drugs

CBER’s Marks Would Resign on Premature Vaccine Approval

CBER director Peter Marks says he would resign if the Trump Administration interfered in an approval decision to speed up access to Covid-19 vaccines. Marks told Reuters that so far he has not felt any political pressure and that the agency will be guided by science alone. Should that change, “I could not stand by and see something that was unsafe or ineffective that was being put through,” Marks said. “You have to decide where your red line is, and that’s my red line... I would feel obligated (to resign) because in doing so, I would indicate to the American public that there’s something wrong.”

HHS assistant secretary for public affairs Michael Caputo told Reuters that the government aims to identify a safe and effective vaccine by 1/2021. Speculation about FDA approving a vaccine under political pressure “only undermines confidence in the public health system,” Caputo said. “I’ve never met one FDA regulator who wouldn’t resign over improper pressure, and that’s how America knows their seal of approval is the gold standard.”

FDA has scheduled a 10/22 advisory committee meeting to discuss pending coronavirus vaccines. Marks said the trials were enrolling volunteers “reasonably well” and that it is “possible” data could be available to interpret as early as October. If not, the committee could still discuss broader regulatory issues regarding a vaccine, he said.

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