Senate confirms Robert Califf as FDA commissioner
The Senate narrowly confirmed Robert Califf as Food and Drug Administration commissioner, over objections to his pharmaceutical industry ties and concerns he would not act aggressively enough to stem the opioid epidemic, according to a CNBC report.
The White House relied on six Republicans to move Califf across the finish line after five Democrats voted against President Joe Biden’s nominee. The final vote was 50-46 for Califf.
“Dr. Califf is a supremely qualified nominee with bipartisan support,” Sen. Richard Burr, the ranking Republican on the Senate health committee, said.
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A prominent cardiologist with extensive clinical research experience, Califf served as FDA commissioner during President Barack Obama’s final year in office. Biden previously said Califf will bring a steady hand to the organization as the drug regulator faces urgent decisions on COVID-19 vaccines, therapeutics and testing to fight the pandemic, according to the report.
Califf’s confirmation comes more than a year after Biden took office. Janet Woodcock, a three-decade agency veteran, served as acting commissioner last year while the FDA gradually lowered the eligibility age for Pfizer’s vaccine, authorized booster shots and approved two major antiviral drugs to treat COVID patients, the report stated.
Taking to social media Woodcock shared news of Califf’s confirmation on Twitter and shared her thoughts on the news.
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"I’m pleased to say that I will be transitioning to the position of Principal Deputy, where I can both continue to work on so many of the issues and challenges we face and to provide ongoing support to the new Commissioner. I look forward to continuing to work in this capacity," Woodcock said.
Though the White House reportedly considered Woodcock for the permanent role, she faced opposition on Capitol Hill. Woodcock led the FDA’s Center for Drug Evaluation and Research when prescription opioids, including OxyContin, were approved in the 1990s, the report said.
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Several pharmacy groups have begun to express their support of Califf's confirmation, including the Association for Accessible Medicines, the Consumer Healthcare Products Association and the American Pharmacists Association.
In a statement, the Association for Accessible Medicines said, “AAM congratulates Dr. Robert Califf on being confirmed to lead the U.S. Food and Drug Administration. AAM and its member companies stand ready to work with Dr. Califf to ensure America’s patients have timely access to safe, effective and quality generic and biosimilar medicines.”
The Consumer Healthcare Products Association followed suit by sharing their own statement of support, which reads, “Dr. Califf is a highly respected clinician and researcher with an outstanding record of public service, including previously serving as FDA commissioner,” CHPA president and CEO Scott Melville said. “CHPA applauds the confirmation of Dr. Califf as FDA Commissioner once again, an experienced choice to lead the Agency at such an important time for public health.”
The American Pharmacists Association also issued a statement, which reads, "APhA looks forward to working with both Califf and the FDA to ensure the safety, efficacy and security of medications for our nation’s pharmacy patients."
“Pharmacists must have trust and confidence in the medical products that their patients rely on,” Ilisa Bernstein, APhA’s senior vice president for pharmacy practice and government affairs, said. “APhA welcomes the experience, dedication and commitment to science and public health that Dr. Califf’s permanent leadership brings to the FDA during these challenging times. As the medication experts, APhA has confidence that Dr. Califf’s focus on science-based decision-making will guide him at the helm at the FDA.”
APhA also thanks Janet Woodcock, MD, for her steadfast leadership as acting commissioner. APhA looks forward to continuing to work with her in her new role as principal deputy commissioner.”