Cardiologist Robert Califf Nominated to Head FDA—Again

For the second time, a US president has picked cardiologist Robert Califf, MD, to head up the Food and Drug Administration, which paves the way for a return to the post Califf held for just 1 year at the end of the Obama administration. After weeks of speculation in the media, President Joe Biden formally announced his decision today.

“Dr. Robert Califf is one of the most-experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic,” Biden’s statement reads. “I am confident Dr. Califf will ensure that the FDA continues its science and data driven decision-making. Dr. Califf had strong bipartisan support in the Senate in 2016, and I urge the Senate to swiftly confirm Dr. Califf so he can continue the important work being done at this critical moment.”

As reported by TCTMD, Califf’s road to commissioner back in 2015 wasn’t entirely smooth, with concerns raised about his “industry connections.” Prior to that earlier nomination, Califf was vice chancellor of clinical and translational research and the director of the Duke Translational Medicine Institute (DTMI) in Durham, NC, where he had earlier been the founding director of the Duke Clinical Research Institute. He served as the FDA's deputy commissioner for medical products and tobacco. 

He was eventually confirmed in 2016 with an 88-to-4 Senate vote. This time around, predicts Politico, which broke the news Friday, “he's likely to be buoyed by endorsements from a bipartisan group of fellow former FDA commissioners—as well as public health experts who have urged Biden for months to settle on a nominee.”

Califf stepped down from his commissioner role under the administration of former President Donald Trump and became head of medical strategy at Alphabet, the parent company of Google. He is also a senior adviser for Verily.

Cardiologists on Twitter and elsewhere have voiced support. American Heart Association CEO Nancy Brown issued a statement saying, “With a distinguished career in medicine and clinical research, which served him so well when he previously served as FDA commissioner, Dr. Califf is ideally suited to lead the agency at this particularly challenging time.”

Moreover, she said, “as a trained cardiologist, an accomplished researcher, and an extraordinary communicator, Dr. Califf brings a patient-centric and collaborative approach to his work that is critical to meeting the many challenges facing the FDA. . . . We look forward to working with Dr. Califf, if confirmed, in support of the FDA’s critical efforts to promote public health and reduce the burden of chronic disease.”