Nov. 15, 2021 – Many in the healthcare space are breathing a sigh of relief that President Joe Biden finally announced his nominee to be the new FDA Commissioner on Nov. 12: former FDA Commissioner Robert Califf, M.D. Although Coalition for Healthcare Communication Executive Director Jon Bigelow believes Califf will win Senate confirmation for a second stint leading the agency, the outcome “is not a slam dunk,” he says.
Califf served as FDA Commissioner for the final year of the Obama administration (his background is outlined here). He now faces hearings before both the Senate Health, Education, Labor, and Pensions (HELP) Committee and the Senate Finance Committee. Bigelow notes that when Califf was nominated for the same role in 2016, he was confirmed by the Senate in an 89-4 vote.
There should be significant support for Califf, considering that 65 of the 89 senators who voted “yes” back then are still in office – which probably factored into President Biden’s decision, Bigelow said, adding that the calculus this time around may be different.
“Expect Dr. Califf to be grilled once again over his ties to biopharma companies that supported clinical trials in which he participated,” he said. “With current concerns about data privacy, expect questions about Verily’s use of patient data [Califf served as Head of Clinical Policy and Strategy at Verily], and questions regarding Dr. Califf’s views on how data is best used. Dr. Califf’s tough stance against tobacco and vaping also may cost him some votes.”
In a Nov. 12 CHC Industry Leaders Alert, Bigelow pointed out that in 2016, the four “no” votes were cast by senators concerned about the FDA’s past role in approving opioid medications; three of those casting “no” notes are still in office.
“Sen. Joe Manchin (D-W.Va.) wasted no time this afternoon in announcing that he again will oppose Dr. Califf, and Sen. Richard Blumenthal (D-Conn.) said he has ‘very grave reservations’ about this nomination.” The third senator who did not vote for Califf in 2016, Sen. Ed Markey (D-Mass.), has not yet posted a statement.
“This means a few Republican votes will be needed to confirm Dr. Califf,” Bigelow remarked. “In today’s environment, where confirmation votes are weaponized, some Republicans who previously voted for Dr. Califf may now oppose anyone Biden has chosen.”
Califf’s confirmation process likely will extend into 2022, Bigelow predicted, given the approaching Dec. 3 deadline for approving a fiscal 2022 budget and raising or suspending the federal debt limit, the ongoing battles over the Build Back Better Act and other legislation, as well as the holidays.”
Bigelow also noted that now that there is an FDA Commissioner nominee, Dr. Janet Woodcock’s tenure as Acting FDA Commissioner is permitted to continue past a federally set deadline of Nov. 16.
Biden, who said in a Nov. 12 statement that Califf “has the experience and expertise to lead the [FDA] during a critical time,” also thanked Woodcock for doing “an incredible job leading the agency” on an interim basis.