FDA Policy/General

FDA Needs to Revamp Advisory Committees: Opinion

FDA needs to revamp its advisory committee process because the agency often stacks the deck with experts that will vote to support its review findings, according to a 12/30 Wall Street Journal opinion piece entitled “The FDA’s Rigged Drug Committees.” The article calls on the incoming Trump Administration to make “dismantling a culture of bureaucratic control” at FDA a top priority, and particularly reforming the advisory committee process, a top priority for 2017.

“If FDA is going to run these committees merely to achieve a predetermined outcome, then let’s skip the exercise,” the opinion piece says. “Drug sponsors should at least be allowed to object to candidates for the panel and be granted time to refute the agency’s contentions, as Joseph Gulfo, executive director of the Lewis Center for Healthcare Innovation and Technology, has suggested. The panels should also include several members who have treated the disease. These changes would return advisory committee meetings to their original purpose as an outside check on FDA bias or groupthink. If Donald Trump is serious about making government accountable to the people who pay for it, FDA is a prime candidate for reform.”

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