Biden nominates Califf as FDA commissioner

Regulatory NewsRegulatory News | 12 November 2021 |  By 

After months of speculation – and just days before a statutory deadline – President Joe Biden on Friday announced he would nominate Robert Califf to serve as Commissioner of Food and Drugs for the second time.
"I am confident Dr. Califf will ensure that the FDA continues its science and data driven decision-making. Dr. Califf had strong bipartisan support in the Senate in 2016, and I urge the Senate to swiftly confirm Dr. Califf so he can continue the important work being done at this critical moment," Biden said in a statement.
Califf, who previously headed the US Food and Drug Administration (FDA) from February 2016 to January 2017, is a renowned clinical trialist and a founding director of the Duke Clinical Research Institute. Since leaving the FDA in 2017, Califf has served as a senior adviser to Alphabet's life sciences arm Verily and has continued teaching, research and clinical duties at Duke University School of Medicine.
The long path Biden took to nominating a permanent commissioner to helm the FDA struck many as a curious move at a time when the agency has had a highly visible role at the forefront of the nation's public health response to the COVID-19 pandemic.
However, many observers' concerns were allayed by Biden's choice of veteran regulator Janet Woodcock to serve as acting commissioner. Woodcock first joined FDA in 1986 and has twice served as director of the Center for Drug Evaluation and Research (CDER), most recently from 2007 to 2020, before stepping away from that role to assist on Operation Warp Speed. Under federal law, Woodcock may only serve in her acting role until 15 November 2021, unless a permanent commissioner is nominated.
Woodcock herself, along with several other prominent public health figures, was vetted for the commissioner job over the last nine months, though opposition from within the Democratic party helped squelch her nomination. One of the leading voices against Woodcock was Senator Joe Manchin (D-WV), who opposed her nomination and continued role as acting commissioner largely due to Woodcock's tenure at CDER through a period when many new opioids, including abuse-prone long-lasting formulations, were approved.
At a press briefing on Friday, White House Press Secretary Jen Psaki said the administration is confident Califf can be confirmed and that the President selected Califf because "he's one of the most experienced clinical trialists in the country, [and he] has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation's fight to put an end to the coronavirus pandemic."
While some Democratic senators, including Manchin and Richard Blumenthal (D-CT) have voiced opposition to Califf, their opposition is not expected to derail his confirmation. Both senators voted against Califf's nomination in 2016, though the Duke researcher and cardiologist enjoyed broad support from Republicans and sailed to confirmation with an 89-to-4 vote. This time around, Califf's detractors are likely to point to his extensive ties to the pharmaceutical and tech industries as reasons for opposing his nomination. (RELATED: Senate Confirms Califf as Next FDA Commissioner, Regulatory Focus 24 February 2016; President Obama Nominates Califf as Next FDA Commissioner, Regulatory Focus 15 September 2015)
Califf received numerous endorsements from industry and other health groups upon news of his nomination today.
"Congratulations to Dr. Robert Califf for being nominated as the next commissioner of the U.S. Food and Drug Administration. It’s vital that we have a commissioner who understands the important role the FDA plays in promoting public health and providing science-based oversight of our nation’s medicine supply. We hope the confirmation process will proceed quickly, and we look forward to continuing to work with the FDA as we fight the pandemic and other deadly diseases," said PhRMA CEO Stephen Ubl. Other backers of the newly named nominee include Research!America, the Consumer Healthcare Products Association (CHPA) and the Friends of Cancer Research.
Steven Grossman, executive director of the Alliance for a Stronger FDA, told Focus he expects Califf will enter the agency with a more pronounced mandate this time around and "act more resolutely" as a commissioner in the first year of a presidency, compared to his previous stint as commissioner in the final year of the Obama administration.
"I believe Dr. Califf’s priorities will have a common theme: FDA modernization. To achieve the greatest benefit for the American people, FDA needs the resources and tools to address acceleration of medical progress and the potential for a dramatically safer food supply. He will, I predict, advocate for data and technology modernization, improved means of recruiting and retaining FDA employees, facilities upgrades, and the means to make the agency’s processes more efficient, accurate, and responsive," Grossman said.
During his last turn as FDA commissioner, some of Califf's top priorities were to reform the clinical trials system and to find ways to better leverage real world evidence. (RELATED: Califf Vows Not to Lower or Remove FDA Regulations, Regulatory Focus 11 January 2016; Califf: Leveraging Real World Evidence is 'Top Programmatic Priority' for FDA, Regulatory Focus 11 May 2016).


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