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.

Califf has extensive experience in clinical trials.

• Before joining the FDA, Califf founded the Duke Clinical Research Institute, the nation’s largest academic clinical research organization, at Duke University where he was professor of cardiology and medicine and where he had earned his bachelor’s and M.D.
• Califf was also director of the Duke University Translational Research Institute and vice chancellor for clinical and translational research.
• Califf is considered a pioneer in clinical trials using thrombolysis for acute heart attack and is regarded as ”a leading authority on clinical trial design and drug regulation.”

Califf has past financial ties to multiple pharmaceutical companies, though they’re considered modest by industry standards.

• From 2013-2018 (the most recent data available) he received a total of $108,551, excluding 2016 when he was at the FDA, from Amgen, AstraZeneca, Bayer, Biogen, Boehringer, Daiichi Sankyo, Eli Lilly, Hoffmann-LaRoche, Johnson & Johnson, Merck, and Sanofi, Squibb.
• Specifically, he received $29,294 in 2013, $34,137 in 2014, $5,467 in 2015 (nearly all AstraZeneca consulting), $10,034 in 2017 (nearly all Merck consulting), and $35,086 in 2018. Other than
• He was also a paid consultant for Merck Sharp & Dohme, Johnson & Johnson, GlaxoSmithKline, AstraZeneca, and Eli Lilly from 2009-2013. His largest single payment during this time was $87,500 from Johnson & Johnson in 2012.
• However, as Matthew Herper reported in 2015, Califf’s fees, nearly all consulting, were earned while convincing large pharmaceutical companies “to do large, expensive, and, for Duke, profitable clinical trials that helped prove the effectiveness of major medicines like Sanofi’s Plavix, Merck’s Vytorin, and Johnson & Johnson’s Xarelto.” Herper adds, “But he has not been a pushover, ever, and his goal has always seemed to be to make sure that doctors and patients have the best evidence possible for deciding what drugs to give to patients. He has not always been easy on industry.”

Recommended reading

• Biden taps Califf to head FDA — an agency where he has plenty of unfinished business at STAT
• Biden nominates Robert Califf, former Obama FDA chief, as agency commissioner at Washington Post
• Biden nominates Califf as FDA chief at Politico
• Biden Chooses Robert Califf to Lead F.D.A., Despite Drug Industry Ties at New York Times
• Manchin opposes Biden FDA nominee at The Hill
• Robert Califf Could Transform the FDA—the Right Way at Forbes (2015)
• Califf to Leave Duke to Become FDA Deputy Commissioner at Forbes (2015)
• Statement from President Joe Biden Announcing His Intention to Nominate Dr. Robert Califf for Commissioner of Food and Drugs from the White House

Writing by Califf

• Clinical Trials in Crisis: Building on COVID-19’s Lessons Toward a Better Future by Califf at Health Affairs (2021)
• Seven Former FDA Commissioners: The FDA Should Be an Independent Federal Agency by Califf at Health Affairs (2019)
• A Proactive Response to Prescription Opioid Abuse by Califf at NEJM (2016)
• Use Of Larger Versus Smaller Drug-Safety Databases Before Regulatory Approval: The Trade-Offs by Califf at Health Affairs (2008)

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.