BIOTECH AND PHARMANEWS

Biden’s FDA Chief Nominee Narrowly Wins Senate Affirmation

Feb. 15, 2022 — Robert Califf, MD, on Tuesday narrowly obtained Senate affirmation to once over again abet as the commissioner of the FDA, overcoming impart votes from lawmakers about abortion and opioid issues.

The Senate voted 50-46 in desire of Califf’s nomination. A cardiologist long affiliated with Duke University and a popular skilled on clinical trials, Califf additionally led the FDA from February 2016 thru January 2017.

In 2016, the Senate confirmed him as FDA chief in an 89-4 vote. At that time, Sen. Joe Manchin, D-WV, and just a few heaps of senators talked about they were fervent Califf’s links to the drug industry would bog down his capacity to retain watch over drugmakers, seriously by manner of principles on prescription painkillers.

Manchin additionally objected to Califf’s second nomination as FDA commissioner, as did several fellow Democrats, including Sen. Edward Markey of Massachusetts. In a press start issued after the Tuesday vote, Markey talked about he has “repeatedly raised issues relating to the FDA’s egregious mishandling of opioid approvals and its position in enabling the latest opioid epidemic.”

“To this level, the FDA mute has now no longer carried out somewhat heaps of the reforms important to guarantee it is far gratifying its position as our nation’s high pharmaceutical cop on the beat,” Markey talked about. “I even accept as true with now no longer bought any exact commitment from Dr. Califf to in fact reform the FDA or to learn from the mess ups that fueled this public health disaster.”

This time, Califf lost enhance among Republican senators due to objections raised by groups seeking to forestall females’s earn entry to to abortion. Susan B. Anthony List and Nationwide Steady to Existence asked senators in a January letter to oppose Califf’s nomination, citing their objections to how the FDA handled reporting of unfavorable occasions from abortions by medication all over 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 desire

On Monday, Sen. Patty Murray, D-WA, chairwoman of the Senate Health, Training, Labor and Pensions Committee, entreated her colleagues to vote for Califf to present the FDA stable leadership to kind out pressing health wants akin to the opioid disaster, adolescence tobacco utilize, antimicrobial resistance, and inequities in health care.

“At this serious moment, we wish a depended on hand to steer the FDA,” she talked about in a floor speech. Califf’s outdated provider on the FDA and his years spent as a overview scientist “give him the journey to make a decision on on this mission.”

One at a time, three vulnerable FDA commissioners on Tuesday printed an thought article that appeared inThe Hill. Republican presidents nominated two of these vulnerable FDA chiefs: Scott Gottlieb, MD, and Mark McClellan, MD. The third, Margaret Hamburg, MD, used to be nominated by President Barack Obama, as used to be Califf for his first time as FDA chief.

There’s an pressing want for a confirmed chief on the FDA as the U.S. seeks to pass past the pandemic, the vulnerable FDA chiefs wrote. The work ahead entails continued efforts with vaccines as effectively as efforts to bolster medical provide chains, they talked about.

Califf “knows easy guidelines on how to advance the safe construction and utilize of medical merchandise and to bring a sound, science-basically basically based completely basis to the FDA’s regulatory actions. Which capability that, he has earned the boldness of FDA’s skilled profession staff, as effectively as a colossal scandalous of patient groups, tutorial consultants, medical professionals and public health organizations,” Gottlieb, Hamburg, and McClellan wrote.

The article additionally used to be signed by vulnerable Centers for Medicare and abortion Services and products Administrator Andy Slavitt, who served in the Obama administration.

Toughen of Scientific Neighborhood

The American Coronary heart Affiliation on Tuesday issued a press start congratulating Califf on his second affirmation after the Senate vote.

“With a famend profession in public provider and an extended-time volunteer chief on the American Coronary heart Affiliation, Dr. Califf has honed his capacity to talk about and assemble belief with various constituencies,” CEO Nancy Brown talked about in the observation. “He’ll utilize his journey as a cardiologist to safeguard the health and effectively-being of of us all the diagram thru the country, and his background in overview to prioritize science and proof-basically basically based completely policymaking.”

Califf used to be additionally backed by the Affiliation of American Scientific Colleges, American Academy of Pediatrics, American Academy of Family Physicians, and American College of Physicians when he used to be nominated for the position final year by President Joe Biden.

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