The Senate narrowly APPROVES Biden’s selection of Robert Kaliff as head of the FDA despite bitter disagreement over how he will handle abortion drugs and the opioid crisis.
- The Senate has narrowly confirmed Robert Kaliff as President Joe Biden’s nominee to head the Food and Drug Administration.
- In a 50-46 vote, Republican support was key, with five Democrats missing the vote.
- Democrats were outraged by the FDA’s handling of opioids during Kaliff’s first tenure as head of the agency.
- Republicans were concerned about Kaliff’s abortion comments
The Senate on Tuesday narrowly confirmed Robert Kaliff as President Joe Biden’s nominee for head of the Food and Drug Administration after some senators argued his ties to the pharmaceutical industry or views on birth control made him unsuitable for this role.
50 votes to 46 means Kaliff, 70, a cardiologist and renowned medical researcher, will once again be head of a powerful regulatory body. He briefly headed the FDA at the end of President Barack Obama’s administration.
The FDA hasn’t had a permanent leader for over a year, despite playing a major role in the COVID pandemic by overhauling vaccines, drugs and tests.
Califf needed Republican support to get confirmation after Biden’s five Democratic senators opposed him.
Democratic opposition included New Hampshire Senator Maggie Hassan, who faced a tough re-election campaign and was critical of the FDA’s handling of the opioid crisis during Kaliff’s tenure; Vermont Senator Bernie Sanders, who said Kaliff’s work with drug companies makes him unable to impartially regulate the industry; and West Virginia Senator Joe Manchin, who also criticized the way the FDA handled the opioid crisis during Kaliff’s time.
Six Republican senators joined the remaining Democrats, resulting in 50 votes in favor and 46 against.
The Senate has narrowly confirmed Robert Kaliff as President Joe Biden’s nominee to head the Food and Drug Administration.
Republican Senator Mike Rounds voted to participate in the so-called “Senate Pair”. Rounds is paired with Democratic Senator Ben Ray Lujan, who is in New Mexico, recovering from a stroke. The current voting rounds made up for the fact that Luhan, who would have voted yes, was not present to cast his vote.
The confirmation battle for Califf this time contrasted sharply with his first confirmation vote, when 89 senators gave him their approval.
The White House has long assumed that enough Republicans would back Califf to easily overcome any Democratic retreat, given his strong support from drug companies and patient groups.
But several Republicans withdrew their support after Califf told the Senate Committee on Health, Education, Labor and Pensions at a December approval hearing that he trusts the FDA to make the right decision as it considers easing restrictions on abortion pills, which it did two days later.
More than a year after the first COVID-19 vaccines were approved, the FDA is still facing a number of key decisions, including whether to expand their use to children under 5 years of age. Last week, the FDA unexpectedly delayed its review of Pfizer’s vaccine for that age group.
FDA commissioners do not usually participate in day-to-day scientific reviews, but serve as intermediaries between the agency’s scientists and the White House. That relationship has escalated over the past year as Biden’s COVID-19 task force has repeatedly outpaced the FDA’s methodical scientific reviews.
Kaliff also needs to replace the head of the FDA Tobacco Center, which is weighing whether e-cigarettes from Juul, Reynolds American and other vaping companies should be banned because of their use by teenagers. This spring, longtime FDA tobacco company director Mitch Zeller is set to step down.
The Food and Drug Administration is also drafting new rules to ban menthol cigarettes, a long-awaited goal for many Democratic lawmakers and public health advocates.
President Joe Biden appoints Dr. Robert Kaliff to head the FDA for the second time — Kaliff led the agency during the end of the Obama administration
In a 50-46 vote, Republican support was key, with five Democrats missing the vote.
Kaliff has publicly championed the potential to save hundreds of thousands of lives by taking advantage of the FDA’s power to ban certain tobacco products and ingredients. Although the FDA has had such powers for more than a decade, its efforts to regulate both traditional cigarettes and e-cigarettes have stalled due to industry lawsuits.
Kaliff first joined the FDA after more than 35 years at Duke University, where he founded a contract research organization that conducts research for many of the world’s largest drug manufacturers.
He left the FDA in 2017 at the start of the Trump administration.
Since leaving government, Kaliff has served as a health policy adviser at Google and has been a board member or advisor to more than half a dozen pharmaceutical and biotech companies. In accordance with federal procedure, Kaliff agreed to step down from all of these positions and sell several million dollars of investments in FDA-regulated companies, according to his ethics disclosure form.