America needs a confirmed leader at FDA — now

Today, senators will have the opportunity to confirm Dr. Robert M. Califf as commissioner of the Food and Drug Administration (FDA) — and they should. Our nation faces critical challenges to public health. Though the pandemic is most urgent, there remain an array of other unmet needs. The FDA is vital to their solutions; more than a year into a new administration, it is long past time to have confirmed leadership at the FDA. 

Senators recognize that the public wants to see decisive steps to move our nation beyond the pandemic. This includes advancing safe and effective vaccines to protect both children and adults, as well as to prevent future variants; converting “emergency use” therapies and tests to products we can use reliably to keep COVID contained for the long term; hardening our supply chains and advanced biologics manufacturing capabilities to prevent shortages; and communicating clearly with the public about these dynamic issues. Now is not the time for prolonged periods of acting leaders at the FDA and our other critical public health agencies. 

Dr. Califf will be able to hit the ground running at the FDA, having previously served as commissioner of the agency from February 2016 to January 2017 after decades of experience as a cardiologist, researcher and public health leader. Dr. Califf earned broad bipartisan support when confirmed then, and for good reason: he knows how to advance the safe development and use of medical products and to bring a sound, science-based foundation to the FDA’s regulatory actions. Because of this, he has earned the confidence of FDA’s professional career staff, as well as a broad base of patient groups, academic experts, medical professionals and public health organizations. 

Senators have rightly highlighted the importance of dealing with the ongoing opioid crisis, which led to the deaths of over 100,000 Americans in the past year. The government’s actions were imperfect when opioids were approved and then began to be misused and diverted on an epidemic scale. The crisis is shifting from one of prescription opioid abuse to one increasingly driven by illicit, synthetic opioids like fentanyl. FDA has a critical role to play in updating the battle plan for today’s war, and Dr. Califf has the experience and commitment to make it happen.

Dr. Califf’s work on combatting the opioid crisis preceded his first term as FDA commissioner.  At Duke University, he worked closely with the National Institute of Drug Abuse to improve and expand clinical trials to better understand how to prevent and treat addiction to opioids and other substances. His work helped launch research networks with the National Institutes of Health and the Patient Centered Outcomes Research Institute that have been instrumental in improving our understanding of pain and its treatment.

During his prior term as FDA commissioner, he initiated the development of a comprehensive framework for evaluating opioids, supported by the National Academy of Medicine and further developed during the Trump administration. Dr. Califf’s work resulted in a requirement for an expert independent advisory committee to review any proposed new opioid without abuse-deterrent properties before it could be approved, and to assess its public health impacts. He also worked with FDA staff to develop new warning labels, and to curb inappropriate prescribing and use. He took actions to increase access to naloxone to reverse overdose, and to medication-assisted treatment to enable recovery.

Since leaving the FDA, Dr. Califf helped found a nonprofit treatment and recovery program, OneFifteen, in Dayton, Ohio, that is serving as a model for prevention and treatment of addiction. As commissioner, he will use this firsthand experience to help lead President Biden’s new Overdose Prevention Strategy, focusing on better prevention, treatment and recovery. His experience in developing new therapies will strengthen collaborations to make available more effective non-addicting treatments for pain. Much more must be done at the FDA to combat the opioid crisis, and it requires a confirmed commissioner with Dr. Califf’s experience.    

The pandemic and the opioid crisis are only the start of the urgent list of reasons to confirm Dr. Califf: implementing legislation to reduce harm from combustible tobacco — still the leading cause of preventable death — while addressing the challenge of youth vaping; assuring that breakthrough medical products for unmet needs are developed efficiently, with the required evidence on safety and effectiveness; and assuring the safety of 85 percent of our nation’s food supply. Under the strong leadership of FDA’s acting commissioner, Dr. Janet Woodcock, the agency’s professional staff have taken many steps to address these and countless other public health threats.

But that’s not enough.

The FDA and the nation need the commitment that the Senate bestows by having a confirmed commissioner, a person guided by science and with a distinguished career of deep commitment to improving the health of the nation. It’s time to confirm Rob Califf.

Scott Gottlieb was FDA commissioner from 2017 to 2019 and is an independent director on the board of Pfizer. Margaret Hamburg was FDA commissioner from 2009 to 2015 and is on the board of Alnylam Pharmaceuticals. Mark McClellan was FDA commissioner from 2002 to 2004, CMS administrator from 2004 to 2006, and is an independent director on the boards of Cigna and Johnson & Johnson. Andy Slavitt was acting CMS administrator from 2015 to 2017 and senior advisor to President Biden’s COVID-19 response team in 2021.