FDA Policy/General

Senate Cloture Vote Passes to Advance Califf Nomination

The Senate 2/22 succeeded (80 to 6) in a cloture vote to advance Robert Califf’s nomination to be the next FDA commissioner. A full Senate floor vote on the nomination could take place as early as 2/23.

Opposition to advancing the nomination was led by Sens. Joe Manchin (D-WV), Edward J. Markey (D-MA) and Richard Blumenthal (D-CT), all complaining that Califf is not the ideal candidate FDA needs to tackle the “deadly epidemic” occurring with prescription opioid products. Manchin and Markey held a press conference earlier before the vote calling for reforms at FDA to respond to the prescription opioid crisis.

“With 51 Americans dying every day due to an opioid overdose, the FDA now more than ever needs a champion who is committed to changing the way the agency handles opioids,” Manchin said. “The FDA needs new leadership, new focus and a new culture. Dr. Califf’s past involvement with the pharmaceutical industry indicates that he will not be this person. He will not have the impact or leadership capabilities that the nation needs to stem the tide of the opioid crisis. It is for these reasons that I am opposing Dr. Califf’s nomination as the FDA commissioner.”

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