FDA still lacks a permanent flagship, despite pressing, weighty problems


The Biden administration has scrutinized candidates other than Dr. Woodcock, but none have been publicly nominated in the sixth month of the president’s term. A White House spokesman would not comment on the delay or on the candidates in dispute. But some people are said to still be in the running: Dr. Joshua Scharfstein, a former high-ranking FDA official and deputy dean of public health at Johns Hopkins University, and Dr. Florence Hohn, a former FDA official. and former Vice President at Celgene who now works as a consultant.

A recent addition to the roster was Dr. Michelle McMurry-Heath, a medical doctor and molecular immunologist who served as an associate science director of the FDA during the Obama administration. But Dr. McMurry-Heath’s candidacy will be complicated by his current job as head of the Biotechnology Industry Association, which lobbies on behalf of biotech businesses.

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

The agency will soon decide whether to grant permanent approval to the three COVID vaccines already in wide distribution under emergency use authorizations, Pfizer-BioNtech, Moderna and Johnson & Johnson. AstraZeneca and Novavax are expected to submit applications for emergency use authorizations for their vaccines soon. They are ending 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 is not yet approved elsewhere. Sanofi is also in the third phase of clinical trials and is expected to be implemented in the fall.

The federal government invested more than $19 billion in vaccines, but less than half of that in medical science. The Biden administration has called for a renewed focus on developing the treatment of COVID and its complications. Several treatments – remdesivir, monoclonal antibodies and the steroid dexamethasone – have improved outcomes for some COVID patients, but they do not work for everyone.

The FDA has promised a new system, known as BEST, to track adverse reactions to COVID vaccines. But it is still not running as promised. Meanwhile, the FDA and the Centers for Disease Control and Prevention are relying heavily on outdated tracking systems, which they admit are deeply flawed, mainly because they rely on patients or health providers without providing evidence. Considers a bad reaction to the vaccine. . There is increasing pressure on the agency to fix the system.

For years, clinics, educational institutions and commercial laboratories have pressured the FDA to develop their own in-house tests for various diseases without agency oversight. For a long time, the FDA has resisted. But in August, the Trump administration ordered the agency to allow these lab-developed tests to detect a range of diseases, including COVID-19, without confirming that they work.



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