Biden’s FDA Pick Gets Bipartisan Support at Senate Panel Hearing

A top Senate Republican joined some Democrats in expressing support for Robert Califf, President Joe Biden’s pick to lead the Food and Drug Administration, at a confirmation hearing Tuesday.

Sen. Richard Burr (R-N.C.), ranking member of the Senate Health, Education, Labor and Pensions Committee, said Califf’s experience in clinical research and his previous time leading the agency during the Obama administration give him a “unique perspective” to serve at the helm once again.

“I’m not sure how to write a resume of somebody more qualified to be considered for commissioner of the FDA,” Burr said during the hearing.

Biden’s FDA Pick Califf to Face Senate Queries on Industry Ties

Robert Califf speaks during a Senate Health, Education, Labor, and Pensions Committee confirmation hearing on Dec. 14, 2021.

Photo: Sarah Silbiger/Bloomberg

The panel’s leader, Sen. Patty Murray (D-Wash.) said she looks forward to working with Califf 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.”

If confirmed, Califf will become the first permanent head of the FDA nearly a year into the Biden administration. Installing a permanent commissioner has been seen as necessary to bring a steady presence amid the ever-evolving conditions of the pandemic.

“This is a once-in-a-generation time for public health, and the FDA must continue to play a vital role in protecting and promoting the health of all Americans by leveraging the acceleration in technology and biomedical knowledge,” Califf said in opening testimony.

Support from Republicans will be critical in moving Califf’s nomination forward. Some Democrats have already signaled opposition, citing Califf’s history of working closely with the pharmaceutical industry. Others, however, say that his vast research on clinical trials and previous work at the FDA make him uniquely qualified to lead the agency.

The HELP Committee hasn’t scheduled a vote on Califf’s nomination, a precursor to a vote in the full Senate.

Califf’s Standing

Several Democrats questioned whether Califf’s longstanding industry ties could affect his ability to tackle the opioid epidemic and demand transparency from pharmaceutical companies.

Califf is “no exception” to the trend of commissioner nominees holding significant experience working for drug companies regulated by the FDA, Sen. Bernie Sanders (I-Vt.), who opposed Califf’s nomination during the Obama administration, said during Tuesday’s hearing.

Califf responded by pointing out that he supports allowing Medicare to negotiate drug prices—a key component of Biden’s Build Back Better package (H.R. 5376). He added that he has committed to the administration’s ethics pledge and to advance the FDA’s mission “to make medical products more effective, safer and more affordable.”

Clinical Trials Headed for Revamp With Califf as FDA Head Pick

Califf also said during the hearing that he supports the approval of more generic drugs as alternatives to brand-name products, which many advocacy groups have called for to help promote competition and drive down drug prices.

Sens. Joe Manchin (D-W.Va.) and Richard Blumenthal (D-Conn.) have both said they would oppose Califf’s nomination due to his pharmaceutical industry connections.

“Dr. Califf’s nomination makes no sense as the opioid epidemic continues to wreak havoc on families across this country with no end in sight,” Manchin said in a statement Tuesday. “His nomination is an insult to the many families and individuals who have had their lives changed forever as a result of addiction.”

Biden’s Drug Agency Nominee Returns With Deeper Industry Ties

Respected Leader

A cardiologist by training and an expert in clinical trial research, Califf is held in high regard by current and former FDA officials. He"had very good relationships with Capitol Hill when he was commissioner the first time,” Howard Sklamberg, who previously served as deputy commissioner under Califf, said.

“While he does have some senators who are opposed his nomination, he doesn’t have the sort of relationship with the Senate where there are dozens of senators who, for either an ideological or personal reason, don’t like the nominee,” Sklamberg added.

Every FDA commissioner who has held the role since 1999 rallied behind Califf’s nomination in a letter sent to the HELP Committee Monday. Installing Califf as the FDA’s leader once again is “critical not only for moving beyond the COVID-19 emergency, but also to help meet FDA’s many other major regulatory responsibilities where Senate confirmed leadership is essential for the nation’s wellbeing,” they wrote.

Califf’s Return as FDA Head Will Give Drug Competition a Boost

Sklamberg and other former FDA officials have said that Califf is likely to refocus attention on issue areas that defined his previous tenure leading the agency, including clinical trial innovation and regulating e-cigarette products.

Califf has advocated for the increased use of real-world evidence to support new drug applications, and has cautioned against using smaller trials that may not be “providing reliable answers” to study questions.

In 2016, the FDA under Califf’s leadership finalized a rule extending its authority to all tobacco products, such as e-cigarettes, cigars, and hookah tobacco. The FDA committed itself earlier this year to banning menthol as a characterizing flavor in cigarettes, as well as all characterizing flavors in cigars.

Califf, if confirmed, will also be tasked with restoring trust to the FDA, which has experienced a pandemic-induced inspection backlog, as well as concerns on whether political pressure has influenced the agency’s Covid-19 vaccine and booster authorization process.