Biologics

Woodcock, Marks Out of Covid Vaccine Review

FDA commissioner Stephen Hahn says that CDER director Janet Woodcock and CBER director Peter Marks will recuse themselves “from the supervisory chain of command in matters related to product review decisions for applications related to the areas that they are advancing that have a nexus to Covid-19.” Hahn issued the statement after questions were raised about a potential conflict of interest with Woodcock and Marks in the Operation Warp Speed public-private partnership announced by President Trump to speed approval of a new vaccine before the end of the year, Endpoint News reports. Woodcock and Marks will continue in their Center director positions, the story says.

Endpoint also reports that after Moncef Slaoui was put in charge of Operation Warp Speed he resigned from Moderna’s board of directors days before the company announced early positive results from its Covid-19 vaccine. He reportedly also sold millions in stock options after he was criticized for a potential conflict.

Before joining the administration effort, Woodcock had said that any vaccine would need large trials for both safety and efficacy to win public acceptance and FDA approval for general administration. She also had said FDA was firm in its position that any Covid-19 therapy would need to be approved on randomized data given the variability in data sets coming from open-label trials and in real-world cohorts.

The advocacy group Public Citizen had raised questions about the participation of FDA executives in the administration task force, seeing it as yet another step away from the agency’s already devalued gold standard.

Public Citizen Health Research Group director Michael Carome told Stat News that “for such senior FDA officials to be serving on the public-private partnership blurs the line between the FDA and regulatory industry to an unprecedented degree. Such relationships could undermine the integrity of FDA’s review of medical products that result from this partnership.”

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