Biden officially nominates Robert Califf as FDA commissioner

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President Joe Biden has announced his nomination of Robert Califf, MD, to serve as the commissioner of the Food and Drug Administration (FDA). Rumors of the nomination have circulated since October, but today’s announcement makes the nomination official. Califf is a cardiologist and researcher who has served as the FDA commissioner previously during the Obama administration.

“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,” said Biden in a statement issued by the White House. “As the FDA considers many consequential decisions around vaccine approvals and more, it is mission critical that we have a steady, independent hand to guide the FDA. 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.”

Industry's response to the nomination has been largely positive.

“CHPA applauds President Biden’s choice for the next permanent FDA Commissioner. Having previously served at the helm of FDA, Dr. Califf is an excellent choice to lead the Agency at such an important time for public health. In addition, his experience and insights on digital health and technology will be critical for helping to shape the future of FDA and the growth of consumer self-care,” said Scott Melville, president and chief executive officer of the Consumer Healthcare Products Association (CHPA; Washington, D.C.), in a press release. “Once confirmed, we look forward to continuing to work with the new commissioner on shared priorities to strengthen the safety and accessibility of self-care options. Our mutual focus includes important regulatory modernization efforts like OTC Monograph reform implementation, modernization of the regulatory framework for dietary supplements, and expansion of conditions for safe use of nonprescription medicines to enable innovations, including Rx-to-OTC switch, both for drugs and for medical devices.”

“NPA welcomes the return of a Senate confirmed commissioner to lead the Food and Drug Administration. If confirmed, Dr. Califf will be responsible for leading the Agency during one of the most challenging moments in history,” said Daniel Fabricant, PhD, president and CEO the Natural Products Associations (NPA; Washington, D.C.). “We look forward to hearing Dr. Califf’s views on enforcing DSHEA, regulating the rapidly expanding CBD industry, and addressing the issue of adulterated ingredients through the NDI process.”

“CRN congratulates Dr. Robert M. Califf for his long-anticipated nomination to FDA Commissioner. We support his confirmation and will look forward to working with Dr. Califf and FDA leadership to strengthen the dietary supplement industry and protect consumers by ensuring products are safe and meet regulatory requirements," said Steve Mister, president and CEO of the Council for Responsible Nutrition, (CRN; Washington, D.C.).

Once confirmed, Califf will take the place of Jane Woodcock, MD, who has been acting commissioner since January 20, 2021.