FRIDAY Jan 14, 2022 – Dr. Robert Califf’s nomination to lead the agency again now heads to the Senate for a vote, after a Senate committee voted on Thursday 13-8 to approve. .
Among those who voted against Califf’s nomination were Democrats who expressed concerns about his ties to pharmaceutical companies, New York times mentioned.
No date has been set for a Senate vote on Califf’s nomination. During the final year of the Obama administration, Califf was confirmed in a vote of 89 to 4 in the Senate to become commissioner of the Food and Drug Administration, times mentioned.
If confirmed again, Calif will take over an agency that has been in the spotlight during the pandemic as it handled decisions about vaccines, treatments, tests and masks, times mentioned.
The agency has come under fire for slow approval of rapid tests at home, which has led to a testing shortage as the Omicron variant rages across the country and consumer demand for tests for schoolchildren and workers soared, times He said.
Meanwhile, high-risk COVID patients face an acute shortage of treatments that can help fight Omicron — even as the FDA remains the gatekeeper for treatments and diagnoses that can help.
Other major challenges facing the FDA are new e-cigarette rules and rapid drug approval, an issue raised by the agency’s approval of the controversial new Alzheimer’s drug, Aduhelm.
Cliff 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, Calif has led clinical trials at Duke University Medical Center in North Carolina for decades. Most recently, he led policy and clinical strategy for Verily, the life sciences arm of Google. During the session, 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, Vermont Democratic Senator Bernie Sanders took Califf to task his relationships with big drug companies, which include consulting fees and stock ownership of up to $8 million.
“This is exactly the close relationship that Big Pharma has exploited to regulate the Food and Drug Administration, rather than the Food and Drug Administration that regulates it,” Sanders said.
In response, Califf told the Senate committee that the Food and Drug Administration and its parent agency, the US Department of Health and Human Services, have strict ethical rules that he plans to follow.
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Posted Jan 2022