Feb. 15, 2022 — Robert Califf, MD, on Tuesday narrowly gained Senate confirmation to at the time once more provide as the commissioner of the Fda, beating protest votes from lawmakers about abortion and opioid concerns.
The Senate voted 50-46 in favor of Califf’s nomination. A cardiologist very long affiliated with Duke University and a observed qualified on scientific trials, Califf also led the Food and drug administration from February 2016 by way of January 2017.
In 2016, the Senate confirmed him as Food and drug administration main in an 89-4 vote. At that time, Sen. Joe Manchin, D-WV, and a several other senators said they had been involved Califf’s back links to the drug marketplace would hamper his capacity to control drugmakers, significantly in conditions of policies on prescription painkillers.
Manchin also objected to Califf’s next nomination as Food and drug administration commissioner, as did numerous fellow Democrats, together with Sen. Edward Markey of Massachusetts. In a assertion issued following the Tuesday vote, Markey reported he has “consistently raised worries about the FDA’s egregious mishandling of opioid approvals and its part in enabling the recent opioid epidemic.”
“To day, the Fda still has not carried out several of the reforms necessary to be certain that it is satisfying its function as our nation’s top rated pharmaceutical cop on the beat,” Markey claimed. “I have not obtained any true commitment from Dr. Califf to really reform the Food and drug administration or to understand from the failures that fueled this general public health crisis.”
This time, Califf missing aid among Republican senators owing to objections raised by groups seeking to finish women’s obtain to abortion. Susan B. Anthony Checklist and Nationwide Proper to Existence asked senators in a January letter to oppose Califf’s nomination, citing their objections to how the Fda handled reporting of adverse functions from abortions by medication through Califf’s tenure.
But some Republicans supported Califf in the Tuesday vote. Sens. Roy Blunt of Missouri, Richard Burr of North Carolina, Susan Collins of Maine, Lisa Murkowski of Alaska, Mitt Romney of Utah, and Pat Toomey of Pennsylvania all voted in his favor
On Monday, Sen. Patty Murray, D-WA, chairwoman of the Senate Health and fitness, Training, Labor and Pensions Committee, urged her colleagues to vote for Califf to give the Food and drug administration strong leadership to tackle urgent overall health desires this sort of as the opioid disaster, youth tobacco use, antimicrobial resistance, and inequities in wellness treatment.
“At this critical minute, we will need a trusted hand to direct the Food and drug administration,” she mentioned in a flooring speech. Califf’s earlier services at the Food and drug administration and his several years spent as a exploration scientist “give him the practical experience to consider on this obstacle.”
Individually, a few former Food and drug administration commissioners on Tuesday printed an belief post that appeared inThe Hill. Republican presidents nominated two of these previous Fda chiefs: Scott Gottlieb, MD, and Mark McClellan, MD. The third, Margaret Hamburg, MD, was nominated by President Barack Obama, as was Califf for his first time as Food and drug administration chief.
There is an urgent require for a verified leader at the Food and drug administration as the U.S. seeks to shift outside of the pandemic, the previous Food and drug administration chiefs wrote. The operate forward contains continued efforts with vaccines as well as efforts to bolster professional medical offer chains, they stated.
Califf “knows how to advance the protected growth and use of healthcare merchandise and to convey a sound, science-primarily based foundation to the FDA’s regulatory actions. Due to the fact of this, he has attained the confidence of FDA’s qualified occupation team, as effectively as a broad foundation of individual teams, tutorial authorities, health care professionals and general public overall health companies,” Gottlieb, Hamburg, and McClellan wrote.
The post also was signed by former Facilities for Medicare and abortion Products and services Administrator Andy Slavitt, who served in the Obama administration.
Help of Clinical Group
The American Coronary heart Association on Tuesday issued a assertion congratulating Califf on his next affirmation just after the Senate vote.
“With a distinguished career in community support and a extensive-time volunteer leader at the American Coronary heart Affiliation, Dr. Califf has honed his means to talk and construct belief with varied constituencies,” CEO Nancy Brown reported in the statement. “He will use his encounter as a cardiologist to safeguard the overall health and nicely-getting of people today throughout the state, and his qualifications in study to prioritize science and proof-dependent policymaking.”
Califf was also backed by the Association of American Health care Schools, American Academy of Pediatrics, American Academy of Family Doctors, and American College or university of Physicians when he was nominated for the role last year by President Joe Biden.
