Biden nominates Califf to head the US FDA

Biden nominates Califf to head the US FDA
Robert Califf was commissioner of the US Food and Drug Administration (FDA) from 2016-2017

15 November 2021 - Deborah Wilkes

  • Robert Califf nominated to be commissioner of the US FDA
  • Califf was previously FDA commissioner from 2016-2017
  • President Joe Biden urges US Senate to “swiftly” confirm appointment

President Joe Biden has nominated Robert Califf – a former commissioner of the US Food and Drug Administration (FDA) – to lead the regulatory agency for a second time.

Biden pointed out that Califf had been FDA commissioner from 2016-2017, following confirmation by the US Senate with broad bipartisan support (click here to read the News story).

He urged the Senate to “swiftly” confirm Califf’s appointment.

“Robert Califf is one of the most experienced clinical trialists in the country and has the experience and expertise to lead the FDA during a critical time in our nation’s fight to put an end to the coronavirus pandemic,” commented Biden. “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.”

A statement from the White House said Califf was an internationally-recognised expert in clinical trial research, health disparities, healthcare quality, and cardiovascular medicine. The statement added that he brought nearly four decades of experience as a doctor, researcher, leader, and public servant.

Currently, Califf is 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 also works as head of clinical policy at Verily Life Sciences.

The White House statement noted that Califf had “led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature”.

Digital health and technology

Scott Melville – president and chief executive officer of the US Consumer Healthcare Products Association (CHPA) – said Califf’s “experience and insights on digital health and technology will be critical for helping to shape the future of the FDA and the growth of consumer self-care”.

Melville highlighted the need for OTC monograph reform implementation, modernisation of the regulatory framework for dietary supplements, and expansion of the conditions for safe use of non-prescription medicines to enable innovations such as prescription-to-OTC switches.

Steve Mister – president and chief executive officer of the US Council for Responsible Nutrition (CRN) – said the industry association looked forward to working with Califf and the FDA leadership to strengthen the dietary supplement industry.

Mister urged Califf to prioritise six items:

  • Increase funding to the Office of Dietary Supplement Programs (ODSP) at the FDA, recognising this office must keep pace with the rapidly growing industry it oversees
  • Work with the US Congress to enact legislation to establish mandatory product listing for supplements
  • Establish a legal pathway to market for hemp-derived cannabidiol (CBD) as a dietary supplement
  • Issue final guidance on the labelling of probiotics
  • Issue final guidance for new dietary ingredients, along with an official list of pre-DSHEA dietary ingredients that are “grandfathered” under the 1994 law
  • Protect consumers and strengthen incentives for innovation with more proactive enforcement of the existing law for dietary supplements

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