Tag Archives: fda commissioner

Tracking the Senate confirmation process for next FDA chief

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Photo courtesy of Wikimedia Commons.

The Senate’s vetting of a proposed Food and Drug Administration (FDA) commissioner may provide an opportunity for reporters to dig into some of the most pressing concerns in U.S. health policy, including the opioid epidemic and the standards used to clear new medical treatments for the market.

President Joe Biden on Nov. 12 announced his plan to nominate Robert Califf as FDA commissioner. Califf served in this same post in the final months of the Obama administration, from February 2016 to January 2017 (Learn everything you need to know about Califf in this blog post.) The next step will be a hearing on the nomination before the Senate Health, Education, Labor and Pensions (HELP) Committee. The committee expects to receive a formal nomination for Califf this week and will schedule a hearing “as soon as possible,” a HELP aide told AHCJ.

Califf likely will face questions during his next round of Senate vetting on some of the same topics he faced on the first round, including FDA’s decisions on food safety and the pace at which it approves generic drugs. Senators will likely ask him to weigh in on controversies that have emerged since, particularly the FDA’s approval of Biogen’s Aduhelm drug for Alzheimer’s disease. (The AHCJ has covered this issue in June and July blogs.)

If confirmed, Califf would also lead the FDA during the next big push in Congress to change how the agency handles drug approvals in general.

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Kerry Dooley Young (@kdooleyyoung) is AHCJ's core topic leader on patient safety. She has written extensively about the Food and Drug Administration, medical research, health policy and quality measurements. Her work has appeared in Medscape Medical News, Congressional Quarterly/CQ Roll Call and Bloomberg News.

Everything journalists need to know about Robert Califf, the newly nominated FDA commissioner

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Robert Califf (Photo by Mark J. Ermarth via Flickr)

President Joe Biden nominated cardiologist Robert Califf for Food and Drug Administration (FDA) commissioner to replace Janet Woodcock, who has been acting commissioner since Biden took office in January. So, who is Califf, and what should journalists know about him? Below is an overview of key facts that journalists may find helpful as a backgrounder as well as some recommended reading for those who have time to learn more.

Overview

  • Califf was most recently a senior research advisor for Verily, a research organization, and Google Health.
  • Califf has served at the FDA previously but is best known for building Duke University’s clinical trials program from the ground up and as an advocate for tobacco control.
  • Despite wide bipartisan support in his previous FDA appointment, Congressional reactions to this appointment are mixed, with particular opposition from Sen. Joe Manchin.

Califf isn’t new to the FDA.

  • He served as FDA Commissioner under President Barrack Obama from February 2016-January 2017, when President Donald Trump took office.
  • Before that, he had been Deputy Commissioner of the FDA’s Office of Medical Products and Tobacco from January 2015 until his nomination and confirmation as commissioner.
  • While at the FDA, Califf pushed to require “black box” warnings about the risks of mixing opioids and benzodiazepines.
  • Califf pushed for using electronic health data and “real-world evidence” while at the FDA.
  • Califf was involved in a controversial decision in 2016 after Commissioner Woodcock granted accelerated approval for eteplirsen, a drug for Duchenne muscular dystrophy, over the objections of agency and external scientists who said there wasn’t adequate evidence that the treatment worked. Califf’s subsequent memo deferred to Woodcock.
  • Califf was allegedly considered for FDA Commissioner in 2009 but was considered too tied to the industry.

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Tara Haelle (@TaraHaelle) is AHCJ's medical studies core topic leader, guiding journalists through the jargon-filled shorthand of science and research and enabling them to translate the evidence into accurate information.

New Republic: Confirm proposed FDA chief now

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The New Republic‘s Jonathan Cohn extols the virtues of public health veteran and pandemic pro Margaret Hamburg, and asks why nothing’s being done to accelerate the confirmation process for the proposed commissioner of the Food and Drug Administration, given that she seems ideally equipped to head an agency with a key role in containing H1N1 flu.

AHCJ resourcesAHCJ resources for covering swine flu, pandemics and preparedness

Her confirmation hearings won’t take place until May 12. That means it’ll be at least two weeks, perhaps more, before she assumes the job.

Today I asked around, in the administration and on Capitol Hill, whether there was some way to move things along more quickly. Nobody I reached seemed to think so. And, oddly, nobody seemed too worked up about the delay.

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.