On February 15, the Senate narrowly confirmed Dr. Robert Califf as the next commissioner of the Food and Drug Administration (FDA). In a bipartisan nail-biter, six Republicans supported him and four Democrats opposed him. Bernie Sanders, an independent, also voted against him, and another senator withheld his vote.
Califf—a cardiologist who has served as the deputy commissioner of the FDA’s Office of Medical Products and Tobacco, as President Barack Obama’s FDA commissioner, and as the head of medical strategy at Alphabet, Google’s parent company—takes over the position from Janet Woodcock, the acting commissioner since President Joe Biden assumed office more than a year ago. The role comes with a long to-do list: During an initial hearing in December, Califf fielded questions from senators about streamlining COVID treatments and tests, dealing with rampant social media misinformation, and addressing an overdose crisis that has only worsened during the pandemic.
“Many senators like Sanders continued to voice their opposition on the basis of Califf’s links to the pharmaceutical industry.”
In the past few weeks, news reports have suggested that the vote would be close, a stark contrast to the last time Califf was approved, by a margin of 89-4 in Obama’s final year in office. With the help of respected medical societies and a collection of former FDA commissioners, the White House has tried to drum up support this month, as many senators like Sanders continued to voice their opposition on the basis of Califf’s links to the pharmaceutical industry.
“Shockingly, nine out of the last 10 FDA Commissioners went on to work for the pharmaceutical industry or to serve on a prescription drug company’s board of directors,” Sanders said in a statement in December. “Unfortunately, Dr. Califf is not the exception to that rule. After leaving the FDA in 2017, he received consulting fees from Merck, Biogen and Eli Lilly. According to his financial disclosure form, he owns up to $8 million in the stocks of major drug companies. That is exactly the close relationship Big Pharma has exploited to regulate the FDA, instead of the FDA regulating them.”
At the confirmation hearing, Democratic Senator Joe Manchin of West Virginia, who managed yet again to insert himself into the center of a major political battle, repeatedly drew attention to Califf’s pharmaceutical ties in the context of the overdose crisis. (In the past few years, renewed attention has been levied on the Sackler family and their Purdue Pharma, which marketed and distributed OxyContin, although this focus is controversial among harm reductionists.)
“I have made it abundantly clear that correcting the culture at the FDA is critical to changing the tide of the opioid epidemic,” Manchin said in November, around the time President Biden revealed Califf’s nomination. “Instead, Dr. Califf’s nomination and his significant ties to the pharmaceutical industry take us backwards not forward. His nomination is an insult to the many families and individuals who have had their lives changed forever as a result of addiction.”
“I have never been more profoundly confident of a vote I’m going to cast than I am right now,” he later said in a floor speech on February 14, adding that denying Califf would “send a message to this administration, to our president, that we need a new direction at the FDA.”
Manchin and others hovered near the clerk, as if standing too close to the television during a big play.
That day, Califf managed to clear a procedural vote, in an apparent indication that he would indeed become the next FDA head. The following morning, three former FDA commissioners—Scott Gottlieb, Margaret Hamburg, Mark McClellan—endorsed Califf in an op-ed in The Hill. “More than a year into a new administration,” they wrote, “it is long past time to have confirmed leadership at the FDA.”
The scene at the hearing was tense. During the tally, Manchin and others hovered near the clerk, as if standing too close to the television during a big play. But the nominee was confirmed by 50 votes to 46. Led perhaps most vocally by Senator Richard Burr of North Carolina, enough Republicans voted in favor of Califf to outweigh the four Democrats who dissented, in addition to the independent Sanders. Stat stated that “no candidate for the agency’s top job has so narrowly squeaked through the confirmation process.”
Now, Califf must confront what many at least hope are the waning days of the pandemic, and he inherits an agency that remains marred by controversy after controversy. Just this past week, the FDA postponed a much-anticipated meeting on the emergency use authorization request for the Pfizer vaccine. In general, though, the FDA has struggled to communicate the efficacy of COVID booster shots for adults and children, witnessed overdose rates hit historic highs, approved a controversial Alzheimer’s drug, and botched an already-opaque procedure for companies to receive authorization to sell e-cigarettes.
Califf’s plate will be full enough with other issues. But when it comes to nicotine alone, he’ll have to steer numerous policies that are expected to be hotly contentious, perhaps more than any others: The FDA has already said that it soon plans to ban the sale of menthol cigarettes and has considered lowering the nicotine content in combustibles to effectively zero. Meanwhile, the agency’s Center for Tobacco Products (CTP) must review the thousands of remaining premarket tobacco product applications (PMTAs) that companies had to file in September 2020, while facing numerous lawsuits from companies whose products have already been denied. Synthetic nicotine has fallen on legislators’ radar, too. Amid all this, Mitch Zeller, who has been the director of CTP for close to a decade, announced that he will retire in April.
As a whole, however, the FDA has never made tobacco control its biggest concern, and industry players, experts, and harm reductionists can only speculate on what Califf might do based on a limited track record—and as nicotine policy could become a hallmark of his tenure. There is some evidence: He has previously supported banning flavored vaping products, failed to subscribe “EVALI” to illicit and tainted THC cartridges, and seemed to advocate for a prescription-only model, which Australia has just adopted.
Many in the vape industry do not see Califf’s confirmation as any sort of victory.
Last June, leading Democrats—including two of the most prominent vaping critics, Senator Dick Durbin and Congressman Raja Krishnamoorthi—scolded Woodcock for not sufficiently addressing youth vaping rates. (Despite these rates markedly decreasing in recent years.) A few weeks later, in a memo revealed from court records, CTP adopted a new, checklist-like “Fatal Flaw” approach to deal with the avalanche of PMTAs, resulting in many companies being summarily denied. Woodcock will now transition to a role known as principal deputy, essentially Califf’s righthand person.
Some in the industry have expressed cautious optimism, but many do not see Califf’s confirmation as any sort of victory. Will he simply pick up where Woodcock left off?
“The FDA has become extremely politicized and his slim confirmation margin is a clear indication he does not have a policy mandate on anything,” a vape industry insider, who requested anonymity so as not to affect the PMTA process, told Filter. “For an agency that is embattled in PMTA litigation and unwilling to admit how flawed their regulation of the vapor industry has been, Califf needs to completely reexamine his agency’s approach to science and data actually guiding product approval decisions.”
Photograph via West Virginia’s Office of the Governor via Flickr/Creative Commons 2.0