Califf heads to Capitol Hill for FDA confirmation hearing

Lauren Gardner and David Lim, Politico: December 14, 2021

CALIFF GETS HIS DAY ON THE HILL — Califf will face the Senate Health, Education, Labor and Pensions Committee today to make his case for returning to FDA as its chief nearly five years after his last stint…. Califf generally has support from the public health community and former FDA officials.


Still, as we’ve previously reported, that doesn’t mean Califf’s confirmation process will be smooth sailing, as some Dems have already registered opposition to the cardiologist over his extensive industry ties. But that resistance is unlikely to keep him from winning enough support, considering he’s already been confirmed once before by the Senate and the White House went so long without even nominating a candidate.

Here are the issues your RxP scribes will be focusing on during the hearing:

Pandemic response


Opioid crisis


Accelerated approval pathways: Califf was FDA commissioner when the agency cleared Spinraza, a highly contentious drug for Duchenne muscular dystrophy, via its accelerated approval pathway. This summer, the agency’s accelerated approval of Aduhelm, a drug for Alzheimer’s disease, sparked an even more voracious debate around the pathway, which allows a drug to be marketed if it improves a surrogate endpoint instead of patients’ health or quality of life. Outcry after Aduhelm’s approval triggered a probe by federal officials into the process, which some experts believe was long overdue.

“In terms of accelerated approval, we’ve been very concerned,” Diana Zuckerman, the president of the National Center for Health Research, a nonprofit think tank based in D.C. “The question for Califf would be, ‘What do you think of this decision, how would you have handled it differently, how will you handle it [now]?’” Without an overhaul of the accelerated approval process, Zuckerman fears that other therapies with little to no evidence of a clinical benefit will hit the market to the detriment of patients.


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