Former FDA Commissioner Robert Califf, M.D., may soon be back at the helm of the FDA. He’ll have a big job to do to restore public confidence in the agency. More on that later.
On November 12, 2021, after nearly ten months without appointing a permanent commissioner, President Joe Biden nominated Califf to retake the job he briefly held under Barack Obama. If the U.S. Senate gives its approval, Califf will take over the agency.
Politics and Medicine
But as we’ve seen with the Senate, a few Senators hold sway in a divided chamber.
In his first go-around for Senate confirmation in 2016, after five months of wrangling, Califf was confirmed by an 89-4 margin.
But this time, Politico reports that Califf is likely to face some opposition in the Senate over his own industry connections and role in the FDA’s past work on opioids.
Three Democrats—Sens. Joe Manchin of West Virginia, Richard Blumenthal of Connecticut and Ed Markey of Massachusetts—voted against Califf in 2016 amid concerns about his ties to the drug industry and the FDA’s track record on opioids. Vermont’s Bernie Sanders ended up not voting. Califf at the time had authored papers with pharmaceutical industry executives and consulted for drug and device makers.
More recently, he has helped lead health policy at Google parent company Alphabet.
Manchin: “An Insult”
On the day of the nomination, Manchin vowed to oppose Califf again, calling his planned nomination “an insult to the many families and individuals who have had their lives changed forever as a result of addiction.”
“I have made it abundantly clear that correcting the culture at the FDA is critical to changing the tide of the opioid epidemic,” he said in a statement. “Instead, Dr. Califf’s nomination and his significant ties to the pharmaceutical industry take us backwards not forward.”
Blumenthal has also signaled he would vote against him again—meaning Califf will need to win over at least a handful of Republicans to win confirmation.
Restoring Trust
If Califf is confirmed, he faces a different environment. Last time he was confirmed it was at the very end of an administration. This time, Steven Grossman, executive director of the Alliance for a Stronger FDA, notes, serving as commissioner early in a presidency allows a commissioner with a greater opportunity to exert influence over the policy direction of the FDA.
“If confirmed, I would expect Dr. Califf to examine the agency more broadly and address priority needs more resolutely than in his prior stint,” Grossman said. “The current situation is very different from being commissioner in the seventh and eighth year, when the White House is less interested and the time frame for changes is quite limited.”
The agency also has different priorities from when he left the position in 2017. In addition to having eight different commissioners since 2015, the agency has had missteps, ranging from its approval of controversial drugs to its perceived bowing to political pressure.
The agency’s early response to the COVID-19 pandemic was jerky. The agency issued an emergency-use authorization for hydroxychloroquine as a treatment for COVID-19, then quickly retracted it. Then in late August, two prominent FDA scientists announced that they would resign after disagreeing with the Biden administration’s plan to offer booster shots, before sufficient data had been collected to prove their necessity.
Public confidence in the agency has been undermined. If approved, Califf is going to have to restore trust in the agency.
Acting Commissioner Janet Woodcock will remain in place while the Senate considers Califf’s confirmation, “to help ensure a smooth transition,” an HHS spokesperson said.
Politico also reported that Califf was not the White House’s top pick. According to a person familiar with the nomination process, he emerged as the top choice in recent weeks after the administration had vetted or spoken to roughly a dozen other people about the job.
During last winter’s presidential transition process, Woodcock was considered for the job. But, according to Politico, her candidacy stalled in the face of Democratic opposition over her track record on opioids and the decision to green-light a controversial Alzheimer’s drug.
Given Califf’s overwhelming confirmation vote in 2017, he once again became the top choice.
Will enough Republican Senators cross the aisle to give the President a victory? Stay tuned.
