In addition to Dr. Woodcock still considered other candidates, but no one was publicly announced as a candidate in 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 F.D.A. Official and Vice Dean of Public Health at Johns Hopkins University and Dr. Florence Houn, a former F.D.A. official and former Vice President at Celgene who now works as a consultant.
Dr. Michelle McMurry-Heath, physician and molecular immunologist who has been appointed Associate Science Director of the F.D.A. during the Obama administration. The candidacy of Dr. McMurry-Heath, however, would be hampered by her current position as director of the Biotechnology Industry Association, which lobbies for biotech companies.
Current and former F.D.A. Industry workers and executives identified 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 F.D.A. 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 F.D.A. and the Centers for Disease Control and Prevention rely heavily on older tracking systems that they acknowledge to be profoundly flawed, largely because they rely on patients or healthcare providers to report bad reactions to the vaccine in their opinion without providing evidence. The agency is under increasing pressure to fix the system.
For years, clinics, academic institutions, and commercial laboratories have been pushing the F.D.A. so that they can develop their own in-house tests for various diseases without official supervision. The F.D.A. has resisted. 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.