Former FDA Commissioner Robert Califf to Return, Confirmed by Senate

Recently, Robert Califf was confirmed by the U.

FDA confirms new commissioner Robert Califf

Califf, who served as FDA commissioner from February 2016 to January 2017, takes over as acting FDA commissioner Janet Woodcock

Analysts at RBC Capital Markets applauded the confirmation, saying Califf could bring regulatory stability by providing more consistent information

"We believe that biopharmaceuticals may benefit from stable guidance, allowing the agency to address controversial topics such as approval of anti-amyloid antibodies (BIIB) and approval decisions for me-too biologics in China, and help The agency is shielded from external political pressure on COVID-related issues, such as the approval of oral Covid-19 drugs and pediatric vaccines," analysts wrote in a note to investors

Additionally, the RBC team, led by Brian Abrahams, wrote in a letter to clients that Califf's experience with big data and views on large randomized trials could also "open the beginning of a greater integration of technology and healthcare, especially in Experimental Design and Data Analysis.

To get the nomination, Califf had to weather bipartisan criticism

Califf's votes for and against are much closer than when he was first nominated to lead the agency

Califf, a cardiologist, became chief medical strategy officer at Google parent Alphabet Inc.

When he takes over, he will face whether to approve Pfizer's COVID-19 vaccine for children 6 months to 4 years old

To secure votes, Califf agreed to review the accelerated approval process through which Aduhelm was approved

"We can expect stricter regulations on which drugs are eligible for approval and the timeline for starting confirmatory studies," RBC analysts wrote

Peter Pitts, a former FDA deputy commissioner and now chairman of the Center for Medicine in the Public Interest, supported the confirmation