FDA Policy/General

Califf Nomination Vote Moving to Senate Floor

In a sign that the Biden Administration and FDA commissioner-nominee Robert Califf’s lobbying efforts are beginning to pay off, Senate majority leader Chuck Schumer filed cloture 2/10, which will likely send the nomination to a Senate floor vote early next week. The move to file cloture is a signal that Senate leaders are confident that enough bipartisan support is present to advance the vote.

Meanwhile, Senate Finance Committee Chair Ron Wyden (D-OR) on 2/10 announced his support for the nomination. On 2/8, Califf promised to address concerns Wyden raised last week about FDA’s drug accelerated approval program. Over the past few weeks, the nomination had begun to stall after five Democrat Senators refused to support it due to variety of reasons (see earlier story).

“As we discussed in our meeting, FDA must ensure that drug developers granted accelerated approval conduct confirmatory studies that demonstrate that the balance of clinical benefit and risk for intended use of the drug is positive, and this must be done in a timely manner,” Califf said in a 2/8 letter to Wyden. “This will be a high priority for me if I am confirmed to serve as the commissioner of the FDA.”

Califf’s letter said that he will ensure that the agency uses “every authority at its disposal to encourage the diligent initiation of well-designed confirmatory studies. I would also welcome the opportunity to work with you, and other members of Congress, on additional authorities to ensure that any gaps in FDA’s ability to hold developers accountable for conducting the studies as quickly as the science allows are closed.”

In response to Califf’s assurances, Wyden said it is troubling that Americans are “paying sky-high prices for drugs that still haven’t been shown to have any clinical benefit, even as companies continue raising their prices... I am prepared to support Dr. Califf’s nomination so that he can shift the FDA into high gear to take action on these challenges, and I will be watching closely to ensure that happens.”

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