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The U.S. Senate on Tuesday confirmed cardiologist Dr. Robert Califf to lead the U.S. Food and Drug Administration for a second time, following what some characterized as a surprisingly contentious approval process.
The vote was 50-46, as reported by the New York Times, with six Republicans and 44 Democrats in favor.
“It has been 391 days since the FDA has had a Senate-confirmed commissioner,” said North Carolina Sen. Richard Burr, one of the Republicans who crossed the aisle to vote for Califf, during a speech Tuesday.
“No matter how effective and successful an acting commissioner may be, and we’ve been blessed with Janet Woodcock’s leadership, the full backing of a presidential nomination and confirmation by the United States Senate carry a weight that allows a confirmed commissioner to push forward necessary, meaningful change and leadership within a federal agency,” Burr continued.
Burr pointed to Califf’s background – which includes his senior advisor role at Verily Life Sciences and Google Health – as leadership strengths.
“He has the robust agency and private sector experience needed to help build on the success of the FDA in helping get Americans back to normal life with the approval of tests, vaccines, and therapeutics that are bringing the pandemic to an end,” said Burr.
“He is the leader we need today, but also for the future,” he added.
However, that very résumé landed Burr in hot water with both Republicans and Democrats, with many of the former balking at his FDA record on abortion policies and some of the latter raising concerns about his pharma connections.
“The current FDA commissioner nominee, Dr. Robert Califf, has significant ties to the pharmaceutical industry, and his leadership of the FDA would take us backward, not forward,” wrote Sen. Joe Manchin, D-West Virginia, and Mike Braun, R-Indiana, in an op-ed published in USA Today this past Friday.
“His nomination is an insult to the many families and individuals who have had their lives changed forever as a result of addiction,” they continued.
Other Democrats who opposed Califf included Ed Markey, D-Massachusetts; Richard Blumenthal, D-Connecticut; and Maggie Hassan, D-New Hampshire. Sen. Bernie Sanders, I-Vermont, who caucuses with the Democrats, also voted against him.
Industry leaders and professional groups cheered the news Tuesday. “NORD and the rare disease community commend the Senate for the confirmation of Robert Califf as commissioner of the FDA,” said National Organization for Rare Disorders President and CEO Peter Saltonstall in a statement.
“Commissioner Califf’s previous experience at FDA gives him critical first-hand knowledge of the unique challenges associated with developing safe and effective treatments for rare diseases, as well as the importance of meaningful partnerships between the FDA and rare disease patient organizations such as NORD.
“NORD is excited to [continue] to drive rare disease innovation alongside FDA and [ensure] the patient voice is incorporated into regulatory decision making,” said Saltonstall.
“CSRxP congratulates Dr. Califf for his confirmation and encourages the FDA to act swiftly to encourage greater competition, transparency and value in the prescription drug marketplace,” said Campaign for Sustainable Rx Pricing Executive Director Lauren Aronson in a statement.
“The FDA can play a critical role in incentivizing the development of drugs that represent a meaningful improvement over existing medications, improving transparency in the prescription drug marketplace, and discouraging drug companies from engaging in behaviors that slow price competition,” Aronson continued.
“Under Califf, the FDA should demand that all new medications provide strong, irrefutable evidence that they are safe and effective prior to reaching the market,” Aronson added. “Such information is critical for patients who are already struggling to afford their medications and will also help discourage Big Pharma from pursuing profits over providing meaningful benefits for patients.”
“Dr. Califf is a skilled and experienced leader, and we congratulate him as he once again takes the helm of the FDA,” said AHIP in a statement.
“This agency plays an essential role in safeguarding the health and well-being of Americans, including their access to effective and safe medications and devices.
“As new drugs come to market, including biologics that represent a new frontier for treatment and cures, the FDA will play an important role in analyzing clinical evidence and ensuring that drug manufacturers bring to market medicines that are proven to work,” the insurance trade association said.
Kat Jercich is senior editor of Healthcare IT News.
Twitter: @kjercich
Email: [email protected]
Healthcare IT News is a HIMSS Media publication.
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