Biden pick to lead FDA fields questions over pharma ties, abortion pill, COVID tests

WASHINGTON — President Joe Biden’s pick to lead the Food and Drug Administration drew praise from a top Senate Republican, as well as critical questions from conservatives and others during a Tuesday confirmation hearing.

Dr. Robert Califf fielded queries on his ties to the pharmaceutical industry, the pandemic-loosened rules around abortion drugs, and frustrations involving COVID-19 rapid tests.

Califf, 70, is familiar with the role he’s been tapped for: He ran the FDA during the last year of the Obama administration. A cardiologist by training, Califf also served as the agency’s deputy commissioner for medical products and tobacco. 

Before those stints with the FDA, he was a professor of medicine at Duke University in North Carolina, where Califf ran the Duke Translational Medicine Institute and the Duke Clinical Research Institute. More recently, he has served as an adviser to San Francisco-based Verily Life Sciences and Google Health.

“I’m not sure you could write a resume of somebody more qualified to be considered for commissioner of the FDA than Rob Califf,” said Sen. Richard Burr, (R-N.C.), the ranking member of the Senate Health, Education, Labor and Pensions Committee. Burr said that he will be urging his GOP colleagues to back the Biden nominee.

If confirmed by the evenly divided Senate, Califf would become the first permanent head of the FDA under the Biden administration — nearly one year after the president took office. 

He would helm an agency that has faced mounting criticism for decisions throughout the pandemic, with rebuilding public trust likely to be a key task. 

Criticism over pharma ties

During Tuesday’s hearing, Califf’s work with major pharmaceutical companies drew sharp words from Sen. Bernie Sanders, (I-Vt.), who fumed that nine out of the last 10 FDA commissioners have gone on to work for the pharmaceutical industry.

“Unfortunately, Dr. Califf, you are not the exception to that rule,” Sanders said, noting the nominee’s consulting work and tallying up to $8 million in pharmaceutical stocks on his financial disclosure form. “How can the American people feel comfortable you’re going to stand up to this powerful special interest?”

Califf responded by pointing to the Biden administration’s ethics pledge, saying he’s agreed to abide by strict ethics guidelines and will be held accountable if he falls short. 

He also stated that he is on record with his support of allowing Medicare to negotiate with drug manufacturers in an effort to reduce soaring prescription costs. 

Sanders isn’t the only senator to have viewed Califf’s pharma ties skeptically: Sen. Joe Manchin III, a West Virginia Democrat, has said he will oppose Califf’s nomination.

Manchin also opposed Califf in 2016 because the senator believes “correcting the culture at the FDA is critical to changing the tide of the opioid epidemic.” According to the West Virginia attorney general’s office, the state has “one of the highest rates in the country of non-medical use of prescription pain relievers among 19-to-25-year-olds.”

Eased access to medication abortion

Several Republican senators, including Sen. Roger Marshall of Kansas, attempted to nail down Califf on whether he supports continuing or undoing the easing of restrictions that allowed for mail-order medication abortion during the COVID-19 pandemic.

A lawsuit last year prompted the FDA to suspend during the public health emergency a requirement that mifepristone must be dispensed in person. Marshall referred to the suspension as a “casual attitude” by the agency to making mifepristone available. 

A review of the regulations surrounding those abortion drugs is currently underway, and Califf noted that he’s not yet a part of any discussions. 

“I think the FDA has to make this decision based on the latest data in the scientific principles,” he said, adding that he trusts the agency staff to make good decisions.

Sen. Patty Murray, (D-Wash.), who is the panel’s top Democrat, returned to the issue at the end of the hearing, telling Califf that she expects any decision on access to medication abortion to be “governed by data, not by politics.”

Rapid test availability 

Much of the agency’s work will remain focused for some time on snuffing out future variants of COVID-19, and ensuring access to the vaccines and tests necessary for the nation to fully return to normal. 

Califf acknowledged the difficulties surrounding the lack of access to testing, which the Biden administration has proposed to ease through insurance reimbursement and free tests for those lacking insurance. 

He offered few specific policy steps, but described rapid testing as a personal issue for him. His son, Sam, had been feeling a little off ahead of traveling to D.C., but was able to get a rapid test at a pharmacy. 

“It was negative, and then we all felt okay about Sam getting on the plane,” Califf said. “And so I think we really have got to redouble our efforts now with omicron.”

Califf also emphasized that more testing allows for catching infections earlier, which can increase the effectiveness of newer antiviral treatments, like a COVID-19 pill touted by Pfizer earlier on Tuesday as highly protective against severe disease.

“There’s a saying: In God we trust. All others must bring data,” Califf quipped, adding that he looks forward to reading the agency’s evaluation of the new antiviral pill.