Weekly Policy Update: FDA Commissioner Nominee Confirmation Hearing

Weekly Policy Update: FDA Commissioner Nominee Confirmation Hearing

Last month, President Biden announced Robert Califf, M.D. as his nominee for Commissioner of the Food and Drug Administration (FDA). Dr. Califf’s confirmation hearing was held this week by the Senate Committee on Health, Education, Labor, and Pensions. This is Dr. Califf’s second time going through the confirmation process for the role, he was confirmed by the Senate to lead the FDA during the final year of the Obama administration in 2016 by a vote of 89 to 4. 

The Association supports policies that lead to greater consistency, predictability, and transparency in the FDA’s review programs and help to bring safe and effective innovative therapies and technologies to patients. It is a positive sign to see stability coming to the FDA after the Administration has had seven commissioners and acting commissioners since 2015. The Administration is currently being led on an interim basis by Dr. Janet Woodcock who has been in the role for close to a year. 

During Dr. Califf’s hearing on Tuesday, he answered questions related to the ongoing pandemic, the opioid crisis, his personal financial ties to the pharmaceutical industry, and potential rule changes for medications used for abortion. On the issue of accelerated approvals, he said, “I am a fan of accelerated approval for the right conditions, in particular for serious diseases for which there is no treatment, however, that can mean more uncertainty, which the FDA must address using data to evaluate products once they’ve reached the market. Technology is making this possible in ways that it wasn’t possible before.”

The committee did not vote at the conclusion of the hearing, and it is expected that a vote would take place in early 2022 before heading to the full senate. Overall, Dr. Califf received positive marks from Democrats and Republicans, hopefully setting the stage for a similar confirmation process he experienced previously, however his confirmation will require bipartisan support.

Notably, several Democrats have already publicly stated that they will oppose Dr. Califf’s nomination. West Virginia Senator Joe Manchin, who has had a long-standing issue with the Doctor related to his previous work handling the opioid epidemic, noted his continued opposition to his appointment, which he also voted against in 2016. Senator Richard Blumenthal of Connecticut, who also voted against the Doctor’s appointment in 2016, will be a no vote as well. Lastly, Senator Bernie Sanders of Vermont noted that Dr. Califf’s financial ties to the pharmaceutical industry are a serious conflict of interest, and he will be voting no. In financial disclosures, Dr. Califf’s indicated receiving consulting fees from Merck, Biogen, and Eli Lilly. 

President Biden’s Nomination Announcement

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. 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.

Dr. Califf is an internationally recognized expert in clinical trial research, health disparities, healthcare quality, and cardiovascular medicine. He brings nearly four decades of experience as a doctor, researcher, leader, and public servant, including previous service as FDA Commissioner from 2016-2017, for which he was confirmed by the Senate 89-4 with broad bi-partisan support. Currently, Califf is a professor of medicine at the Duke University School of Medicine, where he previously served as Vice Chancellor and founded the Duke Clinical Research Institute, and also works as Head of Clinical Policy at Verily Life Sciences, a life sciences research organization. Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature.

The Association is committed to working with Congress, federal agencies, and stakeholders to develop a workable framework for the regulation of diagnostic tests that does not impede patient access to precision diagnostics or restrain innovation.   

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