US Senate confirms Califf as next FDA commissioner

US Senate confirms Califf as next FDA commissioner
Robert Califf will be commissioner of the US Food and Drug Administration (FDA) for a second time

16 February 2022 - Deborah Wilkes

  • US Senate confirms Robert Califf as next FDA commissioner
  • US President Joe Biden nominated Califf in November 2021
  • Califf was previously FDA commissioner from 2016-2017

The US Senate has voted to confirm Robert Califf as commissioner of the US Food and Drug Administration (FDA) for a second time. Califf was previously FDA commissioner from 2016-2017.

Confirmation comes three months after US President Joe Biden nominated Califf to lead the regulatory agency (click here to read the News story).

Scott Melville – president and chief executive officer of the US Consumer Healthcare Products Association (CHPA) – described Califf as an “experienced choice to lead the agency at such an important time for public health”.

“Dr Califf is a highly-respected clinician and researcher with an outstanding record of public service, including previously serving as FDA commissioner,” he commented.

Melville said the recent pandemic had “exposed the critical importance of personal healthcare in public health which Dr Califf recognises”.

“Safe, beneficial, affordable and accessible self-care products – including OTC medicines like pain relievers, dietary supplements like immune support products, and consumer medical devices like face masks and at-home test kits – are essential for diagnosis, prevention, care and overall wellness of Americans,” added Melville.

Priorities for industry

“We look forward to continuing to work with Califf on shared priorities, including OTC Monograph reform implementation, modernisation of the regulatory framework for dietary supplements, and expansion of conditions for safe use of non-prescription medicines to enable innovations including Rx-to-OTC switch,” said Melville.

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.

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”.

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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