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Dr. Robert Califf will once again head the Food and Drug Administration, narrowly securing his position as the head of the consumer safety agency. The Senate confirmed Califf on Tuesday despite some concerns over his close ties to the pharmaceutical industry and GOP opposition to his stance on access to birth control. The Senate voted to confirm Califf on a 50-46 vote, split largely along party lines. Six Republicans — Sens. Roy Blunt, Richard Burr, Susan Collins, Lisa Murkowski, Mitt Romney and Patrick Toomey — voted alongside Democrats to confirm the Duke University cardiologist. (Wise, 2/15)

Robert M. Califf, a cardiologist who led the Food and Drug Administration briefly in 2016, was confirmed Tuesday by a razor-thin 50-to-46 vote for a second stint as commissioner, giving the embattled agency its first permanent head in more than a year. The cliffhanger Senate vote capped a drama that began last fall, when Califf, 71, was nominated by the Biden administration and widely viewed as a shoo-in, given the overwhelming bipartisan support he received in 2016. But this time around, his nomination was endangered by surprisingly strong opposition from most Republicans and a handful of Democrats. (McGinley and Roubein, 2/15)

White House press secretary Jen Psaki said the administration is “thrilled” that the Senate confirmed Califf on a bipartisan basis. “He brings to this critical post a lifetime of knowledge and the institutional experience that will ensure he hits the ground running,” she said. (Perrone and Freking, 2/15)

The vote puts an end to one of the most protracted and controversial confirmation processes in the FDA’s 115-year history. No candidate for the agency’s top job has so narrowly squeaked through the confirmation process. The only candidate that came close was Scott Gottlieb, who led the agency during the Trump administration and was confirmed 57-42. Ultimately, four Democrats voted against Califf’s nomination: Joe Manchin (W.Va.), Ed Markey (Mass.), Richard Blumenthal (Conn.), Maggie Hassan (N.H.). So too did Independent Sen. Bernie Sanders (Vt.) (Florko, 2/15)

At the last minute, Sen. Mike Rounds, R-S-D., changed his "no" vote to "present" to pair with Sen. Ben Ray Lujan, D-N.M, who would have voted in favor of the nomination. Lujan is absent from the Senate after suffering a stroke. Sen. Shelley Moore Capito, R-W.Va., was absent following a recent COVID-19 diagnosis and Sen. Lindsey Graham, R-S.C., was also absent. Califf had to cut deals with multiple lawmakers, trading policy promises for votes. Several Senate Democrats opposed the nomination due to his past ties to the pharmaceutical industry and handling of the opioid crisis when he previously led the FDA. (Cohen, 2/15)

With a permanent political leader in place after a 13-month holding pattern, the agency will be more empowered to move forward with sensitive policies and accelerate its regulatory agenda. Returning to the FDA early in President Joe Biden’s tenure gives Califf greater ability to place his stamp on the agency than the last time he led it during the final months of the Obama administration. Scott Gottlieb, former President Donald Trump’s first FDA commissioner, played an outsized role communicating with lawmakers on Capitol Hill about the agency’s priorities. (Gardner, Foley, Lim and Ollstein, 2/15)

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. (Florko, 2/16)