Califf's confirmation as FDA chief gives biopharma industry a 'steady hand' at the agency: analyst

Meet the new boss. Same as the old boss.

By a narrow vote of 50-46, Robert Califf has been confirmed by the Senate to run the FDA.

Califf, who previously served as the FDA commissioner from February 2016 to January 2017, takes over a job that has been filled by interim chief Janet Woodcock for 391 days.

Analysts at RBC Capital Markets applauded the confirmation, saying Califf can bring regulatory stability by providing more consistent messaging.

“We believe biopharma may benefit from a steady hand to guide the agency through controversial topics such as approvals of anti-amyloid antibody (BIIB) and me-too biologics from China and could help insulate the agency from outward political pressure on matters relating to COVID, such as oral drug approvals and the pediatric vaccine,” the analysts wrote in a note to investors.

Further, Califf's experience in big data and belief in large, randomized trials, may also “usher in the start of greater integration of tech and healthcare, particularly in trial design and data analysis," the RBC team, led by Brian Abrahams, wrote to clients.

In earning the nomination, Califf had to withstand criticism from both sides of the aisle. Many Republicans opposed his confirmation because of what Sen. Tommy Tuberville (Alabama) termed as Califf’s “pro-abortion agenda.”

Some Democrats, meanwhile, saw Califf as too tied to the pharmaceutical industry, citing the FDA’s approval of opioid drugs during his previous tenure, which contributed to the opioid crisis. His most ardent Democratic foe in the Senate was Joe Manchin (West Virginia).

Califf emerged in a much closer vote than when he was first nominated to lead the agency. His tally in 2016 came in at 89-4, while Tuesday’s vote was the closest in the history of the FDA confirmation process. The previous closest decision, 57-42, was to confirm President Donald Trump’s nominee, Scott Gottlieb.

RELATED: Califf advances in FDA chief nomination process but committee vote indicates he's no slam-dunk choice

Califf, a cardiologist, became the chief of medical strategy at Alphabet Inc., the parent company of Google, in 2019.

He takes over as the agency faces decision on whether to clear Pfizer’s COVID-19 vaccine for kids ages 6 months to 4 years. He also comes to the FDA during a period in which it has been the target criticism for its approval of Biogen’s controversial Alzheimer’s drug Aduhelm.

In securing votes to gain the nomination, Califf agreed to review the accelerated approval process, through which Aduhelm was endorsed.

“We can expect greater stringency on which drugs qualify and the timelines for starting confirmatory studies,” RBC analysts wrote.  

RELATED: After Califf survives narrow Senate vote, FDA nominee looks set to be confirmed this week

Peter Pitts, a former FDA associate commissioner and now the president of the Center for Medicine in Public Interest, supported the confirmation.

“Califf 2.0 will unleash the power of the FDA to drive innovation, enhance health literacy and health equity, broaden access to new drugs, and put a stop to drug company shenanigans,” Pitts said in a statement. “Now is the time for the FDA to shine."