Drugs

Use More Advisory Committee Temporary Voting Members: Column

FDA should strengthen advisory committee deliberations by appointing more temporary voting members, according to Center for Medicine in the Public Interest president Peter Pitts and vice president Robert Goldberg. Writing in a Real Clear Health opinion column, Pitts and Goldberg say the agency already has the authority to appoint temporary voting members whose expertise matches the application under review. “It should use that authority much more aggressively,” they say.

While standing committees provide continuity and institutional memory, the column says, continuity is an administrative virtue and not a scientific qualification. “No standing committee can reasonably include the nation’s foremost experts in every rare disease, every emerging technology, and every evolving clinical endpoint,” Pitts and Goldberg write. “Temporary voting members are FDA’s opportunity to close that gap.”

The column acknowledges that the nation’s leading experts are very busy and getting them to come to an advisory committee meeting can be difficult. “FDA should make that investment anyway,” it says.

Pitts and Goldberg also say FDA should continue to refine its approach to committee member conflicts of interest. “Individuals with direct financial interest should not vote,” they say. “At the same time, FDA should not unnecessarily exclude the country’s leading specialists because they have participated in legitimate clinical research or advised companies developing therapies…. Treating experience as a liability often excludes precisely the people FDA most needs to hear from.”

The column concludes that standing committees should provide continuity, while temporary voting members should provide specialized expertise. “Advisory committees exist to improve FDA’s decisions,” Pitts and Goldberg write, “not merely affirm them. The hardest scientific questions deserve the best scientific minds. FDA should settle for nothing less when it builds its advisory committees.”

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