6 approval decisions that will make or break Califf’s first year at the FDA

WASHINGTON — The next year at the Food and Drug Administration is going to make Robert Califf’s marathon confirmation process look easy.

The longtime Duke cardiologist, who was narrowly confirmed by the Senate Tuesday, inherits an agency that is smack dab in the middle of deliberations over a slew of controversial applications for everything from pediatric Covid-19 vaccines to ALS drugs.

Califf likely won’t weigh in on the minutiae of those decisions — it’s extremely rare for the FDA commissioner to do so — but these decisions will have huge consequences for his tenure at the FDA. He will have to explain the decisions to the public, and he will take the blame for any misstep the agency makes.

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