F.D.A. Still Lacks a Permanent Commissioner

In addition to Dr. Woodcock still considered other candidates, but no one was publicly announced as a candidate during the sixth month of the president’s tenure. A White House spokesman refused to comment on the delay or the controversial candidates. But some people who should still be in the running are: Dr. Joshua Sharfstein, a former senior FDA official and Vice Dean of Public Health at Johns Hopkins University, and Dr. Florence Houn, a former FDA official and former Vice President at Celgene who is now a consultant.

A new addition to the list is Dr. Michelle McMurry-Heath, a medical doctor and molecular immunologist who served as the FDA’s assistant scientific director during the Obama administration. But dr. McMurry-Heath’s candidacy would be hampered by her current position as director of the Biotechnology Industry Association, which lobbies for biotech companies.

In interviews, current and former FDA staff and industry executives cited several pressing priorities as the country emerges from the coronavirus pandemic that has gripped the nation.

The agency will shortly decide whether the three Covid vaccines, Pfizer-BioNTech, Moderna and Johnson & Johnson, which are already widely used, will be approved on a permanent basis. AstraZeneca and Novavax are expected to start filing applications for their emergency vaccines shortly. They are completing data collection from their Phase 3 studies in the United States. AstraZeneca is already approved in other countries, although some have restricted its use due to side effects. Novavax has not yet been approved elsewhere. Sanofi is also in phase 3 clinical trials and is expected to apply in the fall.

The federal government invested more than $ 19 billion in vaccines, but less than half of that in therapeutics. The Biden government has called for a renewed focus on developing treatments for Covid and its complications. Several therapies – remdesivir, monoclonal antibodies, and the steroid dexamethasone – have improved outcomes in some Covid patients, but they don’t work for everyone.

The FDA has promised a new system called BEST to track side effects on the Covid vaccines, but it’s still not operating as promised. In the meantime, the FDA and the Centers for Disease Control and Prevention are relying heavily on older tracking systems that they acknowledge to be profoundly flawed, largely because they rely on patients or health care providers to have bad reactions to their opinion report the vaccine without providing evidence. The agency is under increasing pressure to fix the system.

For years, clinics, academic institutions, and commercial laboratories have urged the FDA to develop their own in-house tests for various diseases without regulatory oversight. The FDA has resisted this for just as long. But in August, the Trump administration ordered the agency to approve these laboratory-developed tests to detect numerous diseases, including Covid-19, without first confirming that they work.

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