SENATE CONFIRMS BIDEN’S FDA PICK
Califf given nod to lead agency again in narrow 50-46 vote
The Senate narrowly confirmed President Joe Biden’s pick to lead the Food and Drug Administration on Tuesday, pushing past a thicket of political controversies that threatened to derail what was initially expected to be an easy confirmation.
The 50-46 vote means Dr. Robert Califf, a cardiologist and prominent medical researcher, will again lead the powerful regulatory agency, which he briefly headed during the end of President Barack Obama’s administration.
The FDA hasn’t had a permanent leader in more than a year despite playing a central role in the COVID-19 response effort, reviewing the vaccines, drugs and tests used to fight the pandemic.
The razor-thin vote underscores the increasing political polarization around the health care issues FDA oversees and contrasts with Califf’s overwhelming support just six years ago. The Senate previously confirmed him to the job by a vote of 89-4.
Califf now inherits a raft of decisions pending at the agency, which regulates products that make up an estimated one-fifth of all U.S. consumer spending, including prescription and over-the-counter drugs, medical devices, tobacco products and most foods.
White House press secretary Jen Psaki said the administration
is “thrilled” that the Senate confirmed Califf on a bipartisan basis.
“He brings to this critical post a lifetime of knowledge and the institutional experience that will ensure he hits the ground running,” she said.
Califf ’s to-do list includes specific commitments he’s made to Senate lawmakers to clinch the job. In particular, he has vowed to quickly launch a comprehensive review of opioid painkillers like OxyContin, which helped trigger the worst drug epidemic
in U.S. history after their FDA approval in the 1990s.
Sen. Joe Manchin, DW.Va., urged senators to oppose Califf, saying he bears “a great deal of responsibility” for many of the drug overdose deaths that have occurred in the years since his first stint as FDA commissioner. During his 11month tenure, Califf added new warning labels to opioids and commissioned outside recommendations on how to tighten regulation of the drugs. But he was replaced
by President Donald Trump before implementing any major changes.
“Nothing that Dr. Califf has said or done has led me to believe he will operate the FDA any differently than he did during his previous tenure,” said Manchin, whose home state has been ravaged by the opioid epidemic for nearly 30 years. Four other lawmakers from hardhit blue states also voted against Califf.
The White House long assumed enough Republicans would support Califf to easily
overcome any Democratic defections, given his strong support from pharmaceutical companies and patient groups.
But anti-abortion advocates recently launched a campaign to sink his Senate vote, outraged by a recent FDA decision that eased access to abortion pills. Groups including the Susan B. Anthony List and Students for Life of America threatened to pull support from any Republican senators supporting Califf.
In the end, six Republicans
joined with all but five Democrats in voting to confirm Califf. Sen. Richard Burr, R-N.C., advocated for Califf on the Senate floor, saying that he had not seen someone with such a short previous stint at the FDA who “accomplished anything, much less the many negatives that have been raised.”
“He has the robust agency and private sector experience needed to help build on the success of the FDA in helping Americans get back to normal life with the approval of tests, vaccines and therapeutics that are bringing the pandemic to an end,” Burr added. “He’s the leader we need today, but also for the future.”
Califf will also need to replace the head of the FDA’s tobacco center, which is weighing whether to ban ecigarettes from Juul, Reynolds American and other vaping companies due to their use by teens. FDA tobacco’s longtime director, Mitch Zeller, is set to retire this spring.
Califf first came to the FDA after more than 35 years at Duke University, where he founded a contract research organization that conducts studies for many of the world’s largest drugmakers.
Since leaving government he has worked as a health policy adviser for Google and served as a board director or adviser to more than a half-dozen drug and biotech companies. In keeping with federal procedure, Califf agreed to resign from all of those positions and sell off investments in FDA-regulated companies, according to his ethics disclosures form.