FDA Policy/General

Is FDA Commissioner Nominee in Jeopardy?

FDA commissioner nominee Robert Califf is reportedly losing Senate backing and the White House has been slow to help advance his confirmation standing. Five Democrats — Sens. Bernie Sanders (I-VT), Joe Manchin (D-WV), Ed Markey (D-MA.), Maggie Hassan (D-NH) and Richard Blumenthal (D-CT) — have signaled opposition to Califf’s nomination, but even more remain on the fence, according to a Politico report. Earlier this month, only four Senate Health Committee Republicans — Sens. Richard Burr of North Carolina, Susan Collins of Maine, Lisa Murkowski of Alaska and Mitt Romney of Utah — supported him in a vote that moves his nomination to a full Senate vote probably sometime next month. Burr has been leading the charge to generate more Republican support.

“If the vote were held today, he would not have the votes,” one person with knowledge of the matter told Politico. President Biden probably thought he had a sure bet when he picked Califf for the post in November, especially since he held the post in 2016 and was then confirmed in an 89-4 vote. The White House reportedly is stepping up support now and has dispatched senior aides like chief medical adviser Anthony Fauci, Covid-19 coordinator Jeff Zients and White House staff secretary Neera Tanden to lobby on Califf’s behalf.

Some lawmakers have cited concern about Califf’s ties to industry. He most recently led health strategy and policy at Alphabet, Google’s parent company, and was paid millions in stock and more than $2.7 million in salary and bonuses. He must also divest holdings in health care companies including Amgen, Gilead Sciences, Bristol Myers Squibb and Walgreens Boots Alliance. Several GOP lawmakers have reportedly cited FDA’s recent decision to loosen abortion pill dispensing requirements as reason to oppose Califf. In December, FDA moved forward with a plan to allow patients to obtain a mailed prescription for abortifacient mifepristone through a telehealth appointment.

Alston & Bird attorney Marc Scheineson, who served as associate commissioner for legislative affairs under former FDA commissioner David Kessler, told Politico it is premature to discount Califf’s vote potential. “I think the White House gets the idea this is a priority for them, and between their leverage and Burr’s, the dynamics are good,” Scheineson said. “I’ve heard this will be scheduled or is being considered for the first week of February — obviously, that scheduling depends on having the votes.”

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