Senate Committee Backs Califf Nomination to Head FDA

The nomination of former U.S. Food and Drug Administration head Dr. Robert Califf to again lead the agency now heads to the full Senate for a vote, after a Senate committee on Thursday voted 13-8 for approval.

Among those who voted against Califf’s nomination were Democrats who expressed concerns about his links to pharmaceutical companies, The New York Times reported.

No date for a Senate vote on Califf’s nomination has been set. During the last year of the Obama administration, Califf had been confirmed in a 89-to-4 Senate vote to become FDA commissioner, the Times reported.

If confirmed again, Califf will take over an agency that’s been under the spotlight during the pandemic as it dealt with decisions about vaccines, treatments, tests and masks, the Times reported.

The agency has been criticized for sluggish approval of rapid at-home tests, leading to test shortages as the Omicron variant raged across the country and consumer demand soared for tests for schoolchildren and workers, the Times said.

Meanwhile, high-risk COVID patients are facing severe shortages of treatments that can help battle Omicron — even as the FDA remains the gatekeeper to therapies and diagnostics that could help.

Other major challenges facing the FDA are new e-cigarette rules and accelerated approval of drugs, an issue triggered by the agency’s approval of the controversial, pricey new Alzheimer’s drug, Aduhelm.

Califf appeared before the Senate Health, Education, Labor and Pensions Committee in mid-December, answering questions about the pandemic, the opioid crisis and other topics.

As a cardiologist, Califf led clinical trials at the Duke University Medical Center in North Carolina for decades. Recently, he led clinical policy and strategy for Verily, the life sciences arm of Google. During the hearing, he emphasized the value of existing data, much of it in patients’ electronic medical records, to help answer difficult questions about drugs and devices.

During the hearing, Democratic Sen. Bernie Sanders of Vermont took Califf to task for his ties to major pharmaceutical companies, which include consulting fees and stock ownership of as much as $8 million.

“That is exactly the close relationship Big Pharma has exploited to regulate the FDA, instead of the FDA regulating them,” Sanders said.

In response, Califf told the Senate committee that the FDA and its parent agency, the U.S.Department of Health and Human Services, have strict ethics rules that he plans to follow.

More information

Visit Duke University for more on Robert Califf.

SOURCE: The New York Times

Source: HealthDay