FDA Policy/General

Makary Says FDA Exploring Conditional Approvals

FDA commissioner Marty Makary says the agency will be rolling out soon a new drug approval pathway for rare diseases and incurable conditions. In a 4/17 interview on the Megyn Kelly Show, Makary said the agency will be approving drugs based on a “plausible mechanism and on sort of a conditional basis. Let’s say there's a condition that affects 75 people in the world, and there is a new treatment that makes sense physiologically, and the mechanism is scientifically plausible that this treatment would help these individuals. No one's forcing these medications on these individuals if they want to try these new medications, even though we don't have a randomized control trial, because it's not feasible. We will allow that, and at the same time, monitor everybody who gets it, so that we can make inferences as soon as the data speaks with a signal in the data.”

Kelly asked Makary to comment on the recent forced resignation of CBER director Peter Marks (see earlier story). Makary acknowledged that he never met Marks, and suggested that the concerns with him center on his ouster of the agency’s top two vaccine experts during the Covid-19 emergency — CBER Office of Vaccines Research and Review director Marion Gruber and her deputy, Philip Krause (see story). Makary said the two former vaccine experts had concerns over the Covid mRNA booster repeat strategy as a mandate in children.

Makary told Kelly that there are a lot of talented people who can replace Marks, and “a lot of very smart people who are right now applying for that job.”

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