Nominee for FDA Chief Advances Through Key Senate Committee

In a vote of 13-8, the Senate Committee on Health, Education, Labor, and Pensions (HELP) advanced the nomination of Robert Califf, MD, to serve as commissioner of the FDA.

As the country continues to battle the COVID-19 pandemic, “the scientists and experts at the Food and Drug Administration who are working diligently to ensure we have safe and effective vaccines, tests, treatments, and more, deserve a strong leader who will make sure science always comes first,” said Committee Chair Sen. Patty Murray (D-Wash.) in a press release, noting that she was pleased to see Califf’s nomination advance in a “bipartisan manner.”

Those voting “no” raised concerns about Califf’s close ties to the pharma industry, his past actions related to the regulation of chemical abortions, and his alleged role in driving the opioid epidemic as FDA commissioner in 2016-2017 during a committee hearing in December.

On Thursday, Sens. Bernie Sanders (I-Vt.), Maggie Hassan (D-N.H.), Bill Cassidy, MD (R-La.), Mike Braun (R-Ind.), Roger Marshall (R-Kan.), Tim Scott (R-S.C.), Tommy Tuberville (R-Ala.), and Jerry Moran (R-Kan.) all voted to oppose Califf’s nomination. Sen. Rand Paul, MD (R-Ky.) was not present during the vote.

At the December committee hearing, Hassan — whose home state of New Hampshire has been hit hard by the opioid epidemic — asked Califf why he had not taken steps to revise the label for the controversial and highly addictive opioid Oxycontin. Califf responded that the agency would “aggressively” pursue relabeling the drug.

In a press statement on Wednesday, Hassan again underscored that the next FDA commissioner should acknowledge the agency’s role in “fueling this crisis. After careful review of Dr. Califf’s record, including questioning him during last month’s nomination hearing, it does not appear that things would be different under his leadership and I will be voting no on his nomination.”

Braun and other Republicans also questioned Califf on what they characterized as the agency’s weakening of the Risk Evaluation and Mitigation Strategy (REMS) for the abortion drug mifepristone (Mifeprex). In April 2021, the FDA announced that they would employ a policy of “enforcement discretion” around the requirements for in-person dispensing of the drug, which allowed patients to receive it by mail.

The Susan B. Anthony List, an anti-abortion advocacy group, has been vocal in its opposition to Califf’s nomination, primarily due to their views regarding his past actions at the FDA, arguing that Califf “directed the removal of reporting requirements for complications after chemical abortion — obscuring the real dangers of abortion drugs despite evidence that they are unsafe.”

“If confirmed, Califf will work hand-in-hand with Joe Biden, Xavier Becerra, and the radical abortion lobby to make every mailbox, post office and pharmacy in America function as an abortion center. He must not be confirmed,” wrote the group’s president Marjorie Dannenfelser in a press release.

Sanders highlighted the “several hundred thousand dollars” that Califf made from pharmaceutical companies after leaving the FDA, as well as his stock portfolio of “up to $8 million” in major pharmaceutical company stock, during the nomination hearing in December. Given his industry ties, Sanders questioned whether Califf would be “an independent and strong voice” for the agency.

However, the American Cancer Society Cancer Action Network (ACS CAN) offered its blessing to Califf, noting the FDA commissioner’s role in reviewing innovative therapies and regulating the tobacco industry.

“On behalf of families affected by cancer, ACS CAN urges the Senate to quickly confirm Dr. Califf, so FDA can press forward on these critical issues that have impact on a disease that is expected to kill more than 609,000 Americans this year alone,” wrote president Lisa Lacasse in a press statement.

In December, Califf said his top priority, if he’s confirmed, will be to focus on emergency preparedness and response, as well as to ensure the safety of the food and drug supply, curb the opioid epidemic, develop a “systematic approach” to evidence generation, protect children from tobacco products, and help retain and attract new talent to the FDA’s scientific workforce.

Califf is the head of clinical and policy strategy for Verily Life Sciences, and was a professor of cardiology at the Duke University School of Medicine. He previously served as FDA commissioner from February 2016 to January 2017, confirmed by the Senate in a vote of 89-4.