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FDA Nominee Califf Sails Through Senate Committee Vote

January 15, 2016

In a unanimous voice vote, the Senate’s Health, Education, Labor and Pensions Committee on Jan. 12 voted in favor of Robert Califf to be the next commissioner of the FDA.

But the nominee will face one more barrier as the vote moves to the full Senate. Committee member Sen. Lisa Murkowski (R-Alaska) reiterated her intent to block Califf’s approval until she has reassurances from the agency on mandatory labeling requirements for genetically modified salmon.

Califf received strong support from Committee Chairman Lamar Alexander (R-Tenn.), who praised the nominee as having “impressive qualifications.” Ranking Member Patty Murray (D-Wash.) said he would be a “valuable partner” at the helm of the FDA. She added that his record as a former cardiologist and Duke clinical researcher is “a clear indication that he will be a strong, independent FDA commissioner.”

During a hearing before the Senate HELP Committee last fall, Califf defended his record, emphasizing he would not lower standards for approvals (IDDM, Nov. 20, 2015).

Califf is calling for reform of clinical trials but does not believe new FDA regulations are needed. Instead, he is calling for a combination of small, focused trials for precision medicine and large retrospective trials using electronic health records to lower the costs of clinical trials. Those comments were in response to inquiries from Alexander and Murray during Califf’s confirmation hearing in November 2015.

A full Senate vote on Califf’s confirmation has not yet been scheduled. — Michael Cipriano