President Joe Biden has nominated Dr. Robert Califf, a former commissioner of the Food and Drug Administration (FDA) to head the agency again. Biden’s nomination will now go to Congress, which must 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 stance against Trump Administration’s support of unproven COVID-19 therapies, leave. Posted in January. The FDA is the regulatory agency responsible for reviewing the safety and effectiveness of medicines, medical devices, and therapies and is a key player in the evaluation of vaccines and treatments. with new COVID-19 drugs. Biden left his position open for most of the time — by law, he has until November 15 to appoint a new commissioner — which some health experts say hasn’t helped the public believe trust the agency’s decisions meanwhile. On the other hand, Biden appointed Dr. Rachelle Walensky in charge of the Centers for Disease Control in December, even before he himself took office.
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The FDA has been mired in controversy throughout the pandemic. In early 2020, the agency granted an emergency use authorization (EUA) for hydroxychloroquine, a malaria drug that early studies suggested could help treat COVID-19 and was supported by Trump, but turned out not it come with alot of profit. The agency later withdrew the authorization. In August 2020, the FDA also issued an EUA for convalescent plasma, or plasma obtained from recovered COVID-19 patients and reused to help new patients, but has since restricted its use of the plasma. The contrast of some types of patients with the strongest response to natural infection.
Then in June of this year, the FDA approved a controversial Alzheimer’s drug, the first treatment for the disease, despite concerns among many Alzheimer’s experts about the certainty of data show benefit to patients as measured by cognitive tests. FDA officials also met with one of the drug company’s scientists at a scientific conference that may not be appropriate for a regulatory agency tasked with objectively reviewing safety data and effectiveness of a drug.
Califf, a heart disease specialist at Duke University, served as head of the FDA for a year under President Barack Obama. He brings the agency a deep understanding of the clinical trial process, provides data the FDA reviews for approving new drugs, served as vice president for clinical health and transition at the FDA. Duke University. He is also a senior advisor to Verily Life Sciences and Google Health. However, there were concerns about where his allegiance lay. During his September 2016 nomination hearing for his role under the Obama Administration, he was challenged by several Democrats, including Senators Elizabeth Warren and Bernie Sanders, who questioned his relationship. His close ties to the pharmaceutical industry. In a 2017 podcast, Califf admitted that during the hearings, Warren had “taken me through hell” asking questions about how clinical trials work and the relationship and role of the industry. in that process.
During Califf’s brief tenure at the FDA, he followed the advice of the agency’s expert advisory committee on the drug eteplirsen, a new treatment for muscular dystrophy. The Commission considers that the risks of the drug outweigh the benefits; Califf approved the drug, backing the decision of its judicial authorities, arguing that under expedited approval, effective when there is an unnecessary need and no available treatment method. For a rare condition, the FDA has the authority to approve what it believes is in the best interest of the patient.
Already, Senator Joe Manchin of West Virginia, a Democrat opposed to Califf’s first nomination given his perceived proximity to the pharmaceutical interests that fueled the opioid crisis, has voiced continued opposition to Califf’s takeover of the FDA. “NS. Califf’s nomination and his vital relationship with the pharmaceutical industry will keep us from moving forward,” Manchin said in a statement reacting to Biden’s selection. his nomination is an affront to the many families and individuals who have had to change their lives forever due to addiction.I cannot support Dr. Califf’s nomination in 2016 and I cannot support his nomination. support it now”.
In 2016, however, Califf was finally confirmed by an 89-4 vote.
