Confirming the next FDA commissioner is a matter of national preparedness

The COVID-19 pandemic has shown in bold relief our lack of national preparedness in the realm of public health emergencies. As the current pandemic evolves, we need to be prepared for more twists and turns with new variants emerging. This will require at least two essential ingredients: a clear vision of the types of medical interventions needed and leaders who are empowered to refine and execute that vision. That is why it is urgent to confirm a commissioner for the U.S. Food and Drug Administration (FDA).   

For the past year, the FDA has been under the direction of Acting FDA Commissioner Dr. Janet Woodcock — a highly qualified and committed leader, with decades of experience and a deep understanding of science — but an acting commissioner nonetheless. Our experience in Washington has shown that any person with “acting” in their title is by nature limited in their ability to implement innovations to enhance the agency’s work, regardless of qualifications.  

As physicians and researchers familiar with the importance and operation of the FDA, we believe our nation’s ability to respond to public health threats of all types requires permanent leadership, and Dr. Robert Califf is the right person at the right time.  

Califf, a cardiologist by training, is a skilled leader who knows the FDA well from his previous tenure as commissioner, for which he was confirmed with bipartisan support, and from his role as deputy commissioner of the FDA’s Office of Medical Products and Tobacco. As physicians who know Califf’s work well, we believe he will offer immediate stability and effective leadership based on his knowledge of the agency. No less than six former FDA commissioners also agree he is the right person for the job.   

As public health preparedness measures go, the Senate’s confirmation of Califf to be FDA commissioner is as vital as equipping the Strategic National Stockpile with supplies and working to ensure equity in the distribution of vaccines.   

Woodcock and the FDA’s other talented career staff rightly deserve recognition for overseeing several major historic milestones, among them awarding the first COVID-19 vaccines full FDA approval, expanding them beyond Emergency Use Authorization, and widening eligibility for booster shots. But much more remains ahead that will require careful yet expeditious FDA review beyond the realm of therapeutics and vaccines related to COVID-19.  

The broad scope of the FDA, which oversees the safety and efficacy of our food supply, pharmaceuticals, medical devices and much more, demands a permanent leader who will set an agenda for the agency to advance innovation, in addition to combatting the pandemic.  

As Sen. Richard Burr (R-N.C.) put it during Califf’s confirmation hearing before the Senate HELP committee in December, “We need a wartime commissioner who will lead us through the next phase of the response to coronavirus and build a stronger, more nimble FDA for patients and America’s consumers.”  

Califf also has an in-depth understanding of the people and processes involved in evaluating research findings and bringing life-changing innovations to the American public, through his experience as vice chancellor for clinical and translational research at Duke University, director of the Duke Translational Medicine Institute, and founding director of the Duke Clinical Research Institute. As leaders of an organization that represents the nation’s academic medical centers, where groundbreaking research discoveries are made and brought to patients, we see Califf’s extensive leadership in clinical and translational research as a significant advantage for the FDA role.   

Perhaps above all else is Califf’s personal and genuine passion to advance the public good, having initially experienced firsthand the wonders of medical advances 44 years ago when his infant daughter benefitted from open heart surgery. His commitment to strengthening a successful and collaborative FDA is essential to advance the agency’s mission of protecting the public’s health. His nomination is supported broadly by the health and scientific community, with endorsements from the American Heart Association, National Organization for Rare Disorders, American Academy of Pediatrics and many others.    

As the coronavirus continues to pose a threat across the country and around the globe, the FDA will continue to play an instrumental role in the nation’s response. We also need the FDA to continue its other ongoing work that affects us all.  

This time, we know some of the most important ways for the federal government to be prepared. The Senate must act swiftly to confirm Califf as FDA commissioner, without further delay.  

David J. Skorton, MD, is president and CEO of the Association of American Medical Colleges. 

Ross McKinney Jr., MD, is the Chief Scientific Officer of the AAMC and worked with Califf in a previous role at Duke University Medical Center.

Tags emergency use authorization Federal government of the United States Food and Drug Administration Health in the United States Healthcare in the United States Janet Woodcock Richard Burr Robert Califf u.s. food and drug administration

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