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Monday, August 2, 2021

FDA still has a permanent chief, despite impressive, weighty issues

The government of Biden has other candidates besides dr. Woodcock was nominated, but no one was publicly announced as a nominee in the sixth month of the presidency. A White House spokesman declined to comment on the delay or the candidates being challenged. But some people who are still said to be on the move include: dr. Joshua Sharfstein, a former high-ranking FDA official and vice dean for public health at Johns Hopkins University and dr. Florence Houn, a former FDA official and former vice president at Celgene who now works as a consultant.

One recent addition to the list is dr. Michelle McMurry-Heath, a medical doctor and molecular immunologist who served as co-scientific director of the FDA during the Obama administration. But dr. McMurry-Heath’s candidacy would be hampered by her current position as head of the Biotechnology Industry Association, which works on behalf of biotechnology enterprises.

In interviews, current and former FDA employees and industry executives mentioned several urgent priorities as the country emerged from the coronavirus pandemic that gripped the country.

The agency will soon decide whether to grant permanent approval to the three Covid vaccines already being distributed under emergency use authorizations, Pfizer-BioNTech, Moderna and Johnson & Johnson. AstraZeneca and Novavax are expected to submit applications for emergency approvals for their vaccines soon. They have finished collecting data from their US Phase 3 trials. AstraZeneca is already authorized in other countries, although some have restricted its use due to side effects. Novavax has not been approved elsewhere. Sanofi is also in phase 3 of clinical trials and expects to apply in the fall.

The federal government has poured more than $ 19 billion into vaccines, but less than half of them into therapeutic drugs. The administration of Biden has called for a new focus on the development of treatments for Covid and its complications. Several therapies – inhibitor, monoclonal antibodies and the steroid dexamethasone – have improved the outcome for some Covid patients, but it does not work for all.

The FDA has promised a new system, known as BEST, to detect adverse reactions to the Covid vaccines, but it still does not work as promised. Meanwhile, the FDA and the Centers for Disease Control & Prevention rely heavily on older detection systems that they say are severely flawed, mainly because they rely on patients or healthcare providers to report what they believe are adverse reactions to the vaccine, without providing evidence. . . The agency is under increasing pressure to fix the system.

Clinics, academic institutions, and commercial laboratories have been pushing the FDA for years to have their own tests developed for various diseases without the supervision of the agency. Just as long, the FDA resisted. But in August, the Trump administration ordered the agency to allow these lab-developed tests to be used to detect numerous diseases, including Covid-19, without first confirming that it works.

Nation World News Deskhttps://nationworldnews.com
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