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Senate Committee Considers FDA Commissioner Nominee

December 17, 2021

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CONTACTS
Christa Wagner, Manager, Government Relations

The Senate Health, Education, Labor, and Pensions (HELP) Committee hosted a Dec. 14 hearing on President Joe Biden’s nomination of Robert Califf, MD, to be the commissioner of the Food and Drug Administration (FDA).

At the hearing,  Committee Chair Patty Murray (D-Wash.) entered into the record a Dec. 13 letter from AAMC President and CEO David J. Skorton, MD, in support of the nomination. “Dr. Califf’s previous experience as FDA commissioner and as deputy commissioner of the Office of Medical Products and Tobacco will allow a seamless transition to the role and help ensure stability in the midst of the persisting public health emergency,” Skorton wrote. The AAMC previously issued a press statement following the announcement of Califf’s nomination on Nov. 12 [refer to Washington Highlights, Nov. 12].

In her opening statement, Murray highlighted the ongoing pandemic, youth tobacco use, antimicrobial resistance, and improving health equity — including diversifying clinical trials — as pressing challenge areas on which the new FDA commissioner should focus.

“Dr. Califf has worked on these issues before — when he was previously confirmed to lead FDA in an overwhelming bipartisan vote — and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first,” Murray stated.

Committee Ranking Member Richard Burr (R-N.C.) focused on the FDA’s adaptation to address COVID-19 and his impression that the agency should continue moving forward rather than reverting to pre-pandemic operations. “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 American consumers. … Dr. Califf’s unique perspective as a former FDA commissioner, coupled with his understanding of partnerships with the private sector and academia that assist in fueling innovation, will be vital if confirmed as the next FDA commissioner,” he said.

In his opening statement, Califf outlined that his priorities, if confirmed, would be emergency preparedness and response, consumer and patient protection, and modernization and innovation.

Murray and others asked Califf about his plans to address the ongoing opioid use crisis. He responded by emphasizing the significance of prescriber education, tracking opioid prescriptions, and supporting the development of non-opioid pain treatments.

Several members brought up the high cost of prescription drugs and the need for better access to more clinical trials. Sen. Mitt Romney (R-Utah) asked if the government should play a larger role in funding clinical trials. Califf replied, “I would like to see more government-funded trials so that we ask the unbiased questions about which therapies are the best for which people,” and cited the Patient-Centered Outcomes Research Institute as an example of an important source of comparative clinical trials to improve patient care.

Sen. Chris Murphy (D-Conn.) asked Califf about the role of digital technologies in expanding clinical trials access, to which he responded by highlighting the importance of telehealth in increasing participation in clinical trials.

Both Murray and Burr mentioned the committee’s upcoming work to reauthorize the FDA’s user fee programs. Burr added that the trend for user fee revenues to support 45% of the FDA’s budget is “alarming,” saying that the FDA should rely on Congress, not industry, for its funding.

The HELP Committee will need to reconvene in an executive session to vote on whether to refer Califf’s nomination to the full Senate. A date for that session has not been announced.

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