Biden Nominated a New Food and Drug Administration Head…Finally
raised by many Alzheimer’s experts about the robustness of the data showing benefit for patients as measured by cognitive tests. FDA officials also met with one of the drug company’s scientists at a scientific conference, which may have been inappropriate for a regulatory agency that is tasked with objectively reviewing safety and efficacy data for a drug.
Califf, a heart disease expert at Duke University, served as head of the FDA for a year under President Barack Obama. He brings to the agency a strong understanding of the clinical trial process, which provides the data the FDA reviews in order to approve new drugs, having served as vice chancellor for clinical and translational health at Duke University. He was also a senior advisor to Verily Life Sciences and Google Health.
During Califf’s brief tenure at the FDA, he overruled the advice of the agency’s expert advisory committee on the drug eteplirsen, a new treatment for muscular dystrophy.
Already, Sen. Joe Manchin of West Virginia, a Democrat who opposed Califf’s first nomination over his perceived closeness to pharmaceutical interests that perpetuated the opioid crisis, voiced his continued opposition to Califf taking over the FDA. “Dr. Califf’s nomination and his significant ties to the pharmaceutical industry take us backwards not forward,” Manchin said in a statement reacting to Biden’s choice.
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