Senate confirms Califf as FDA commissioner

Regulatory NewsRegulatory News
| 15 February 2022 | By Michael Mezher 

Three months after his nomination by President Joe Biden, and despite weeks of uncertainty over whether he could muster enough Republican votes to overcome Democratic defectors in a narrowly split Senate, Robert Califf was confirmed as commissioner of the US Food and Drug Administration (FDA) for the second time on Tuesday in a 50-46 vote.
The vote came after the confirmation cleared a procedural hurdle on Monday, in which five Republicans joined most Democrats in a 49-45 vote to avoid a filibuster.
Califf, who previously headed FDA during the final year of the Obama administration, is a renowned clinical trialist and founding director of the Duke Clinical Research Institute. Since leaving FDA in 2017, Califf has served as a senior adviser to Alphabet’s life sciences arm Verily and has continued teaching, research and clinical duties at Duke University School of Medicine.
While Califf enjoyed broad Republican support during his nomination in 2016 – he was confirmed with an 89-4 vote – the longtime cardiologist faced opposition on both sides of the aisle, with his detractors citing his close ties with industry, his record on opioids, as well as the agency’s actions related to the abortion drug mifepristone both during his last stint as commissioner and during his confirmation this time around. (RELATED: Senate confirms Califf as next FDA commissioner, Regulatory Focus 24 February 2016)
At the outset, Califf’s confirmation seemed like a sure thing, with lawmakers on both sides of the aisle stressing the need for Biden to nominate a permanent FDA commissioner amid the COVID-19 pandemic. However, that quickly changed last month when the vote to advance his nomination out of committee was much closer than anticipated. (RELATED: Senate committee advances Califf’s nomination as FDA commissioner, Regulatory Focus 13 January 2022)
After it became clear that his nomination was endangered, Califf and the White House spent the last few weeks trying to shore up support from senators. In the process, Califf offered commitments to key senators who were on the fence about his nomination to secure their votes. Among his offerings, Califf pledged he would make enforcing accelerated approval requirements a “high priority” and committed to making a stronger ethics pledge. (RELATED: Califf skates through nomination hearing, Regulatory Focus 14 December 2021)
On Monday, it appeared those efforts paid off. After hearing Sen. Joe Manchin’s (D-WV) plea to reject Califf’s nomination, five Republicans -- Sens. Roy Blunt (R-MO), Richard Burr (R-NC), Susan Collins (R-ME), Lisa Murkowski (R-AL) and Mitt Romney (R-UT) – made up for the four Democrats and Sen. Bernie Sanders (I-VT) who voted against advancing the nomination.
Those same five Republicans were joined by Sen. Patrick Toomey (R-PA) in voting to confirm Califf on Tuesday.


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