Robert M. Califf, a cardiologist who led the Food and Drug Administration briefly in 2016, was confirmed Tuesday by a razor-thin 50-to-46 vote for a second stint as commissioner, giving the embattled agency its first permanent head in more than a year.
Sen. Bernie Sanders (I-Vt.) and four Democrats voted against Califf’s confirmation: Richard Blumenthal (Conn.), Maggie Hassan (N.H.), Joe Manchin III (W.Va.) and Edward J. Markey (Mass.). They opposed Califf because of his prior work with the pharmaceutical industry and what they called the FDA’s lax record on opioids.
Their objections, in the evenly divided Senate, meant that the White House relied on a half-dozen Republicans to back Califf and rescue the nomination: Roy Blunt (Mo.), Richard Burr (N.C.), Susan Collins (Maine), Lisa Murkowski (Alaska), Mitt Romney (Utah) and Patrick Toomey (Pa.).
Many of the Republican “no” votes reflected vehement opposition from Susan B. Anthony List and other antiabortion groups that were angry because the FDA eased restrictions on the abortion pill when Califf was agency chief the last time and again in December, right after his confirmation hearing.
Califf has refused “to distance himself from the FDA decision to abandon vulnerable pregnant women to the reckless and predatory actions of the abortion industry,” Sen. Steve Daines (R-Mont.) said before the vote.
Califf, an accomplished researcher and clinical trial expert, takes the reins of an agency that has been stretched to the limit by demands for new coronavirus vaccines — including a pediatric version for children younger than 5 — and treatments and tests. Other looming challenges include an ongoing controversy over the FDA’s approval of a hotly debated Alzheimer’s drug and battles over flavored e-cigarettes.
Even in non-pandemic times, the FDA has a far-reaching impact on the U.S. economy. It regulates products that account for 20 cents of every dollar spent by consumers, including cosmetics, sunscreen and almost four-fifths of the nation’s food supply. It oversees prescription drugs, the blood supply and medicinal maggots for wound care.
Since January 2021, the agency has been led by acting commissioner Janet Woodcock, a veteran drug regulator who has been regarded within the administration as an able and steady hand, and was close to being nominated last year for the commissioner post. But she ran into a buzz saw of opposition from Manchin and some other Democrats on the opioid issue. In a statement after Califf’s confirmation, she said she will become principal deputy commissioner, the FDA’s second-in-command.
In November, the administration nominated Califf, who spent much of his career at Duke University School of Medicine, where he was founding director of the Duke Clinical Research Institute. The institute, one of the largest academic clinical trial operations in the world, works closely with drug companies to conduct research and test products. Trials led by Califf resulted in important cardiology drugs, experts say.
Califf left the FDA in 2017 at the start of the Trump administration. He later became a senior adviser for Verily, the Alphabet-owned research organization devoted to life sciences, earning more than $2.7 million in salary between January 2020 and roughly mid-October 2021, according to Califf’s financial disclosures. He netted more than $77,600 serving on the board of two pharmaceutical companies, and stock options with Verily and the drug firms.
Califf allies have argued that he conducted himself with integrity while working with drug companies and that his expertise on scientific data and clinical trials would prove valuable to the FDA. Shortly before the Senate vote, Sen. Patty Murray (D-Wash.), the chair of the Health, Education, Labor and Pensions Committee, and Burr, the ranking Republican, urged their colleagues to confirm Califf.
“He has the robust agency and private-sector experience to help build on the success of the FDA in helping Americans get back to normal life” as the pandemic recedes, Burr said.
But in blistering comments Monday, Manchin asserted that Califf, during his previous tenure at the agency, had shown “a complete lack of interest in actually making the difficult decisions that we need,” including on opioids, and that the agency needed fresh leadership.
To try to assuage critics, Califf promised in his confirmation hearing to conduct a comprehensive review of opioids.
In recent weeks, the administration ramped up efforts to salvage the increasingly imperiled nomination. It dispatched top officials such as presidential counselor Steven J. Ricchetti; Jeffrey Zients, the coronavirus response coordinator; and Health and Human Services Secretary Xavier Becerra to call senators. Cardiology and patient groups stepped up their push for Califf.
For his part, Califf met with about four dozen senators, according to the White House.
To win the support of Sen. Elizabeth Warren (D-Mass.), who expressed concerns about his industry ties, Califf agreed to additional ethics restrictions including recusing himself as commissioner for an additional two years from involvement in matters related to companies with which he had a working relationship.
To appease Sen. Ron Wyden (D-Ore.), Califf said he would scrutinize the agency’s accelerated approval program, which allows drugs for serious illnesses to enter the market more quickly. Drug companies that receive such approvals are required to conduct follow-up trials to confirm a clinical benefit to patients, but sometimes fail to do so.
Califf told Wyden he would make sure that pharmaceutical firms submit the required studies in a timely manner.
Califf will also face a full complement of tobacco issues. Antismoking advocates are calling for faster action on removing flavored e-cigarettes from the market, noting the FDA faced a court-ordered deadline of Sept. 9 to make decisions on vape applications. The agency has barred many products but still is weighing the fate of the most popular ones. The FDA said in a statement it “continues to make significant progress on our comprehensive actions” to protect the public from the harms of tobacco products.
In addition, the agency said last April it would propose a ban on menthol cigarettes. The FDA also is considering requiring tobacco companies to reduce the amount of nicotine in cigarettes to nonaddictive levels — which Califf has previously indicated he supports. And some congressional Democrats are pressing the agency to do more on synthetic nicotine amid reports vaping manufacturers may be switching to lab-made products in an attempt to sidestep the agency.
“Never before has there been a more urgent need for FDA to have a permanent commissioner ready and prepared to not just act, but drive a vision for the future,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids.
The agency also is wrestling with the thorny issue of pediatric coronavirus vaccines. Last week, the FDA reversed course on its strategy for authorizing Pfizer-BioNTech shots for children younger than 5, saying the agency will hold off on a decision until it sees data that includes a third shot. The move means it will probably be at least mid-April before the shots are available for that age group.
As commissioner, Califf will almost certainly defer to the FDA’s career scientists on the matter. But he might play an important role in working with other agencies, such as the Centers for Disease Control and Prevention, and in trying to explain FDA decisions to anxious parents.