Drugs

OIG Report on Accelerated Approval Due in 2023

The HHS Office of Inspector General (OIG) says its report assessing how FDA implements the accelerated approval pathway is expected to be issued in 2023. In an online notice, the OIG says FDA’s recent approval of Biogen’s Aduhelm (aducanumab) to treat Alzheimer’s patients “raised concerns due to alleged scientific disputes within FDA, the advisory committee’s vote against approval, allegations of an inappropriately close relationship between FDA and the industry, and FDA’s use of the accelerated approval pathway.” The OIG review was requested by FDA acting commissioner Janet Woodcock in response to the concerns raised over the Aduhelm approval.

The OIG will assess the agency’s use of the accelerated approval pathway in response to these concerns, the notice says. The work plan calls for reviewing interactions between FDA and outside parties as well as other aspects of the process, such as deciding on the accelerated pathway and scientific disputes.

“We will review FDA’s relevant policies and procedures, determine compliance with them, and make appropriate findings and recommendations based on a sample of drugs approved using the accelerated approval pathway, which will include Aduhelm,” OIG says. “We will not assess the scientific appropriateness of FDA’s approval of any of the drugs under review.”

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