FDA Policy/General

The Case for FDA Advisory Committees: Column

Writing in an online LinkedIn column, BoldApprovals managing director Steven Cohen makes the case that FDA advisory committees matter. “They make a real difference during the approval of a new treatment that has an impact at multiple levels, including public health, public policy, engagement, participation, trust, openness to the media, governmental transparency, scientific discourse, and evidence-based medical decision-making,” Cohen writes. “They also make a difference for many different stakeholders and communities — patients, families, healthcare professionals, drug developers, researchers, regulators, public watchdogs, advocates, and activists.”

After reviewing FDA’s original policy statements on the role, activities, and benefits of advisory committees, Cohen points out that the agency has relied on them much less in the current administration. “FDA has cancelled many planned advisory committee meetings without rescheduling them and has scheduled only a few new ones,” he says. “To date, there have been nine meetings for drugs and biologics this year, only four of which were for new therapies. With no more scheduled for the rest of the year, this year’s total number will be well below the over 30 meetings FDA held last year.”

According to the post, the central value of an advisory committee is the opportunity for the sponsor, the public, and stakeholder communities to contribute to FDA’s considerations and decisions. He says a committee can make the difference between approval or rejection of a new treatment, between the treatment reaching everyone for whom it has a favorable benefit/risk ratio or just a fraction of the population who could benefit, or between a strong claim of efficacy or a weak one. “There is a striking correlation between the voting results of advisory committees and subsequent FDA decisions,” he writes. “While the strength of the association is highest for positive votes, many of the approvals following negative votes have occurred after a substantial delay, suggesting that the sponsor may have been able to provide additional evidence to support approval.”

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