Senate Health Panel Questions FDA Nominee Dr. Robert Califf

December 17, 2021

On Tuesday, December 14, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on the nomination of Dr. Robert Califf to be FDA Commissioner.

In his testimony, Califf, who briefly led the FDA during President’s Obama’s second term, said his first priority as FDA Commissioner would be the pandemic response and applying lessons learned from the current pandemic to the next one. Second, he would examine a new approach to evidence generation that would improve patient safety and efficacy in practice.

Senator Mitt Romney (R-UT), who sits on the HELP Committee queried Califf on improving and increasing funding for clinical trials. Romney asked if the federal government should fund more clinical trials. Califf said that he hoped the government would continue to fund clinical trials as there are many issues of importance to public health that only the government could help solve. He noted that the Patient-Centered Outcomes Research Institute (PCORI) was created for this purpose.

Sen. Richard Burr (R-NC), ranking member on the commiittee, noted that the pandemic demonstrated the ability to quickly develop and approve safe and effective medicines and technologies, and urged the FDA to streamline the review of new products built on these cutting-edge platforms. He also noted the importance of the reauthorization of the user fee programs.

Sen. Bernie Sanders and other liberal members of the committee were critical of Califf alleging ties to the pharmaceutical industry and emphasizing the opioid crisis that occurred during his previous tenure as FDA Commissioner.

Meanwhile, 55 organizations have sent a letter to Senate leaders urging that “development of post-market data to
monitor use of medical products” as priority for next Commissioner.

Other topics covered during the hearing included, COVID-19 therapeutifs, drug pricing, anitmicrobial resistance, accelerated approval pathways and advanced manufacturing, among others.

Califf is expected to be confirmed with bipartisan support, but a vote in the full Senate is not expected until next year.