The US Food and Drug Administration (FDA) “yawned” its way through the pandemic and put the public’s health at risk with inadequate inspections of Covid-19 vaccine and drug trials, an investigation has claimed.
Experts say there was not enough scrutiny of drugs developed at “warp speed” during the pandemic and have called for more funding and better efficiencies at the agency.
The report in The BMJ reveals that only one out of 153 trial sites for the vaccine developed by Pfizer were monitored by the FDA ahead of the vaccine being licensed. With the Moderna vaccine, only 10 trial sites out of 99 were inspected and only five out 73 remdesivir sites were visited by the FDA.
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The investigation also highlights how a whistle-blower’s concerns about misconduct at Pfizer Covid-19 vaccine trial sites still did not prompt a visit from FDA inspectors.
Brook Jackson, who was regional director, raised concerns about falsified data, unblinded participants, and poorly trained vaccinators, saying: “I thought that the FDA was going to swoop in and take care of everything.”
Experts say there have been problems with the agency prior to the pandemic and not just around the number of inspections. They have accused the FDA of not being proactive when it comes to letting public or scientific journals know when violations are identified.
This unwillingness to disclose when failings are discovered is “endangering public health”, according to David Gortler, a pharmacist and pharmacologist who worked as an FDA medical reviewer and as a senior advisor to the FDA commissioner.
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Some experts have said that a shortage of inspectors and funding is the root problem of the FDA’s shortcomings, while others have argued that the agency FDA already receives a robust budget and should work more efficiently.
The report also highlights how some believe the FDA was wrong to scale back its operations during the early months of the pandemic, when its presence was needed more than ever.
Following a damming report in 2007, which revealed that the FDA audited less than 1% of trial sites between 2000 and 2005, the agency created a task force to improve the conduct of trials.
Read the full story in The BMJ.
