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US President Biden nominates Robert Califf as FDA commissioner

Biden said Califf has both the experience and expertise to lead the FDA “during a critical time in our nation’s fight” against the coronavirus pandemic

FDA

The White House has finally announced its nominee for Commissioner of the Food and Drug Administration (FDA) after nearly a year without a permanent chief.

Describing Dr Robert Califf as “one of the most experienced clinical trialists in the country” with more than 1,200 publications in the peer-reviewed literature, President Biden said he had both the experience and expertise to lead the FDA “during a critical time in our nation’s fight” against the coronavirus pandemic.

With nearly 40 years’ experience as ‘a doctor, researcher, leader and public servant’, Califf is also familiar with the role after leading the agency for a year under Barack Obama.

One possible attraction for the White House is that Califf was easily confirmed in 2016 with strong bi-partisan support in the Senate. The announcement of a nominee had been expected as Woodcock cannot legally continue as acting head without a permanent head being nominated.

“As the FDA considers many consequential decisions around vaccine approvals and more, it is mission critical that we have a steady, independent hand to guide the FDA,” said Biden. “I am confident Dr Califf will ensure that the FDA continues its science and data driven decision-making… I urge the Senate to swiftly confirm Dr Califf so he can continue the important work being done at this critical moment.”

Califf is currently a professor of medicine at the Duke University School of Medicine, where he previously served as Vice Chancellor and founded the Duke Clinical Research Institute. He is also head of clinical policy at Verily Life Sciences, a company under Google’s Alphabet umbrella.

Many have welcomed the nomination, including the Pharmaceutical Research and Manufacturers of America (PhRMA) and Washington senator Patty Murray, chair of the influential Committee on Health, Education, Labour and Pensions (HELP), who said that she looked forward to working with him “to see our nation through this pandemic and to tackle other critical challenges like the ongoing opioid crisis, rising youth tobacco use, high drug prices, health inequities and more”.

However, his close links with Google and work advising pharmaceutical companies, including Merck and Johnson & Johnson, have attracted criticism.

Democratic senator from West Virginia, Joe Manchin, said the decision made “no sense” due to Califf’s “significant ties to the pharmaceutical industry”. He said: “His nomination is an insult to the many families and individuals who have had their lives changed forever as a result of addiction. I could not support Dr Califf’s nomination in 2016 and I cannot support it now.”

Manchin also said that “correcting the culture” at the FDA was critical to “changing the tide of the opioid epidemic”. His mention of that crisis is telling as acting commissioner Woodcock has been sharply criticised for her handling of it while she was head of the Centre for Drug Evaluation and Research (CDER).

Article by
Hugh Gosling

16th November 2021

From: Regulatory, Healthcare

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