Training fields

Biden chooses to lead FDA questions on pharmaceutical links, abortion pill and COVID testing


WASHINGTON – President Joe Biden’s choice to head the Food and Drug Administration drew praise from a senior Senate Republican, as well as critical questions from Tories and others in a confirmation hearing on Tuesday.

Dr Robert Califf answered questions about his ties to the pharmaceutical industry, the pandemic’s loosened rules for abortion drugs, and frustrations involving rapid COVID-19 tests.

Califf, 70, is well aware of the role he was asked for: he led the FDA during the last year of the Obama administration. A cardiologist by training, Califf has also served as the agency’s deputy commissioner for medical products and tobacco.

Prior to these stints at the FDA, he was professor of medicine at Duke University in North Carolina, where Califf headed the Duke Translational Medicine Institute and the Duke Clinical Research Institute. Most recently, he was an advisor to San Francisco-based Verily Life Sciences and Google Health.

“I’m not sure you can write the resume of someone more qualified to be considered a commissioner of the FDA than Rob Califf,” said Senior Fellow Sen. Richard Burr (RN.C.) of the Senate on health, education. , Work and Pensions Commission. Burr has said he will urge his GOP colleagues to support candidate Biden.

If confirmed by the equally divided Senate, Califf would become the first permanent chief of the FDA under the Biden administration – almost a year after the president took office.

He would run an agency that has come under increasing criticism for his decisions throughout the pandemic, with restoring public trust likely a key task.

Pharmaceutical Links Reviews

During Tuesday’s hearing, Califf’s work with major pharmaceutical companies drew harsh words from Sen. Bernie Sanders (I-Vt.), Who blasted that nine of the last 10 FDA commissioners continued to work. for the pharmaceutical industry.

“Unfortunately, Dr Califf, you are no exception to this rule,” said Sanders, noting the candidate’s counseling work and totaling up to $ 8 million in pharmaceutical stocks on his financial disclosure form. “How can the American people feel comfortable that you will oppose this powerful special interest?” “


Califf responded by pointing out the ethical commitment of the Biden administration, saying he was committed to following strict ethical guidelines and that he would be held accountable if he failed to do so.

He also said he spoke in favor of Medicare negotiating with drug manufacturers in an effort to reduce skyrocketing prescription costs.

Sanders isn’t the only senator who viewed Califf’s pharmaceutical ties with skepticism: Senator Joe Manchin III, a Democrat from West Virginia, said he will oppose the appointment of Califf.

Manchin also opposed Califf in 2016, as the senator believes that “correcting the culture at the FDA is essential to changing the course 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 those aged 19 to 25.”

Easy access to abortion drugs

Several Republican senators, including Sen. Roger Marshall of Kansas, have attempted to determine whether he supports continuing or rescinding the easing of restrictions that allowed mail-order medical abortion during the COVID-19 pandemic.

A lawsuit last year prompted the FDA to suspend a requirement that mifepristone be dispensed in person during the public health emergency. Marshall called the suspension a “flippant attitude” on the part of the agency to make mifepristone available.

A review of the regulations surrounding these abortion drugs is currently underway, and Califf noted that it is not yet part of the discussions.

“I think the FDA needs to make this decision based on the latest scientific evidence,” he said, adding that he trusted agency staff to make good decisions.

Senator Patty Murray (D-Wash.), Who is the first Democrat on the panel, returned to the issue at the end of the hearing, telling Califf that she expects any decision on access medical abortion is “governed by data, not politics.”

A home COVID-19 test kit. (Laura Olson / US Newsroom Office)

Rapid availability of tests

Much of the agency’s work will remain focused for some time on eliminating future variants of COVID-19 and ensuring access to the vaccines and tests necessary for the country to fully return to normalcy.

Califf acknowledged the difficulties with lack of access to testing, which the Biden administration offered to alleviate through insurance reimbursement and free testing for those without insurance.

He proposed some specific policy measures, but described the rapid test as a personal problem for him. Her son, Sam, was feeling a little unwell before he went to Washington, but was able to take a quick test at a pharmacy.

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

Califf also pointed out that more tests can detect infections earlier, which may increase the effectiveness of new antiviral treatments, such as a COVID-19 pill presented by Pfizer earlier on Tuesday as highly protective against serious illness.

“There is a saying: In God we trust. Everyone else has to bring data, ”Califf joked, adding that he was eager to read the agency’s assessment of the new antiviral pill.

Source link