President’s Biden’s nomination of Robert Califf to head the Food and Drug Administration is in the political crosshairs. Curiously, the attacks are not from the usual suspects. Instead, they are friendly fire discharged by an unlikely trio of Democrats: Sens. Bernie Sanders, Elizabeth Warren, and Joe Manchin, who are concerned about Califf’s past involvement with the pharmaceutical industry.
These concerns are unwarranted and show a disturbing lack of understanding and superficial knowledge of the experience needed in drug development and clinical research to lead the nation’s leading regulatory agency for therapeutics.
Califf is a clinical cardiologist who was the founding director of the Duke University Clinical Research Institute (the first and leading academic clinical research organization in the country). Throughout his career, Califf has worked to improve the way new medicines and devices are tested by developing innovative clinical trial designs. His productivity, innovation, and vision brought him to the pinnacle of academic medicine.
His work also required him to interact extensively with the pharmaceutical industry, not in a way that made him carry their water but in ways that provided him with firsthand and in-depth experience with the development of new treatments as well as the government approval and regulatory process.
I say this not as a casual observer but as someone with personal knowledge and professional experience with Califf. I was on the faculty of the University of North Carolina School of Medicine in 1999 when I received the largest grant ever given by the National Institute of Mental Health: to carry out the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study. I was aware of Califf’s ground-breaking research in cardiovascular disease, in which he conducted innovative yet tightly controlled clinical trials that produced results that were generalizable to real-world practice — that’s no small feat in medical research — and thought the CATIE trial could benefit from his knowledge.
So I traveled the eight miles down “tobacco road” between the UNC and Duke campuses to seek his advice. Putting aside the intense basketball rivalry between the two schools, Califf generously advised me how to address study design questions such as sample selection, outcome measures, and statistical methods for data analysis. Six years later, the results of the CATIE study were published in the New England Journal of Medicine. It remains one of the most highly cited scientific reports on the treatment of mental illness.
A decade later, as FDA commissioner during the Obama administration, Califf invited me (in my role as president of the American Psychiatric Association) to a daylong meeting he had convened with key mental health organizations to listen to their concerns about lack of innovation in psychotropic drugs, too many “me-too” drugs, excessive prices, and restrictions on access, and share his vision and plans. His administrative and political abilities to manage the formidable challenges of leading this critical and complex agency of the federal government were on full display. But more importantly, he demonstrated a capacity to connect to the various leaders of important but often-neglected mental health constituents — mental health providers, patients, families, advocacy groups, researchers, and more. He was able to hear their concerns, answer their questions, and give them hope.
Manchin’s claim that “Dr. Califf’s nomination and his significant ties to the pharmaceutical industry take us backwards not forward” is preposterous. And by adding that his nomination “is an insult to the many families and individuals who have had their lives changed forever as a result of [opioid] addiction,” Manchin reflects an utter lack of understanding of the opioid epidemic, the nominee’s record, and FDA history.
Califf had no direct involvement with any opioid manufacturer or connection to the crisis, other than being one of nine FDA commissioners who presided over the FDA in the 30-year period during which drug approvals and marketing practices gave rise to the opioid epidemic. Moreover, his 10-month tenure as head of the agency at the end of the Obama administration was the shortest of all commissioners during this period. To consider Manchin’s canard a valid basis to reject Califf is self-defeating and reflects the flippant and irresponsible nature of his opposition.
As serious as the opioid epidemic is, claiming thousands of lives a year in the U.S., there are other concerning ethical and regulatory lapses by the FDA. The crisis of the moment is clearly the mismanagement by the federal government — predominantly the FDA and Centers for Disease Control and Prevention — of the Covid-19 pandemic, beginning with the lack of laboratory testing assays, followed by the unavailability of test kits and supplies, and finally the confusion over the communication, distribution, prioritization of eligible recipients, and implementation of vaccines, which diminished the stunning success of their development by the pharmaceutical industry.
In addition, old problems, like the high cost of drugs and price controls, persist and new ones have emerged: the controversy over the FDA’s approval of Biogen’s Alzheimer’s drug Aduhelm, with its questionable efficacy and exorbitant price tag; the looming tsunami of technology-assisted health care; telemedicine; new forms of brain stimulation; and the burgeoning interest in the use of psychedelic drugs as treatments. The FDA also faces the challenge of how best to harness the power and reap the benefits of the life sciences industry juggernaut, which is developing technologies such as CRISPR, robotics, artificial intelligence, nanomedicine, medical imaging, digital health care applications, and telemedicine, as well as new forms of therapeutics. To expedite their development but also protect the public interest and keep people safe, the FDA must have capable leadership that ensures a reliable and efficient regulatory process.
These issues, rather than being reasons to question Califf’s competence, strengthen his candidacy. His qualifications make him the best person to helm the FDA now and possibly be the best qualified candidate in the agency’s history. If Congress fails to confirm Califf, it will be depriving the FDA and the country of the best person at a most critical time.
Leading the FDA is a daunting challenge. The agency’s mission of approving safe and effective drugs — as well as foods, vitamins, nutritional supplements, nutraceuticals, and health aids — is hampered by antiquated legislation annotated by a patchwork of amendments. What’s more, the agency is underfunded and understaffed.
The next FDA commissioner must be selected based on qualifications and expertise, not distorted perceptions or as a reward for political patronage and contributions as if it were a prized ambassadorship or some other honorific appointment. Too much hangs in the balance.
Jeffrey A. Lieberman is a psychiatrist, chair of psychiatry at Columbia University Vagelos College of Physicians and Surgeons, a past president of the American Psychiatric Association, and the author of “Shrinks: The Untold Story of Psychiatry” (Little, Brown and Company, 2015).
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