Biden Nominated a New Food and Drug Administration Head…Finally

Robert Califf was nominated to the post of head by President Joe Biden. He is a former Commissioner for the Food and Drug Administration (FDA). Biden’s nomination will now go to Congress, which has to confirm Califf.

Since Biden took office, health officials have been waiting for him to appoint a new head after Dr. Stephen Hahn, who was widely criticized by the scientific community for not taking a stronger stand against the Trump Administration’s support of unproven COVID-19 therapies, left the post in January. FDA, the FDA’s regulatory agency is responsible for reviewing drug safety and effectiveness and for the evaluation of new COVID-19 treatments and vaccines. Biden left the position open for nearly maximum time allowable—by law, he had until Nov. 15 to appoint a new commissioner—which some medical experts say have not helped public confidence in the agency’s decisions in the meanwhile. Biden, however, appointed Rachelle Walensky, the Centers for Disease Control’s new chief, to the position in December before he took office.
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In the midst of the pandemic, FDA was mired in controversy. In 2020, an agency approved emergency use authorization (EUA), for hydroxychloroquine. It was a malaria treatment that had been suggested in early research to possibly treat COVID-19. Trump supported the idea, but it didn’t prove much of a benefit. It was later withdrawn by the FDA. Convalescent plasma was also approved by the FDA in August 2020. It is plasma taken from COVID-19-recovered patients. The FDA later only allowed plasma from those patients who responded the best to natural infections.

Then in June of this year, the FDA approved a controversial Alzheimer’s drug, the first treatment for the disease, despite concerns 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.

For one year, President Barack Obama appointed Califf as the FDA head. As vice chancellor of clinical and translational healthcare at Duke University, he brings to FDA a solid understanding of clinical trials, which provide the FDA with data for approval. He also served as a senior advisor at Verily Life Sciences, and Google Health. There have been questions about his loyalty. He was quizzed by many Democrats including Senators Elizabeth Warren, Bernie Sanders and others about his close connections to the pharmaceutical industry during his nomination hearing in September 2016. In a 2017 podcast, Califf admitted that during the hearings, Warren “put me through hell” in questioning how clinical trials work and the relationship and role of industry in that process.

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. Californiaf approved the drug after the committee deemed the risk outweighed the benefit. He also supported the official decision by his officials. FDA can grant approval under expedited approval. This is when FDA feels it is best for patients.

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. “His nomination is an insult to the many families and individuals who have had their lives changed forever as a result of addiction. I could not support Dr. Califf’s nomination in 2016 and I cannot support it now.”

But, in 2016, Califf was confirmed with an overwhelming 89-4 vote.


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