insufficient monitoring of clinical trial sites for Covid-19 vaccines and drugs, which were developed at “warp speed.”mRNA vaccine, only nine were inspected by the FDA prior to licensing. In addition, just 10 out of 99 trial sites for Moderna and five out of 73 trial sites for remdesivir received inspections from the FDA.
The FDA is “endangering public health” by not being candid about violations that are uncovered during clinical trial site inspections, says David Gortler, a pharmacist and pharmacologist who worked as an FDA medical reviewer between 2007 and 2011 and then as a senior advisor to the FDA commissioner in 2019-2021.
“I don’t think that it is a sufficient number of staff to do that kind of level of oversight,” says Jill Fisher, professor of social medicine at the University of North Carolina. “The FDA must have enough of a presence to dissuade investigative sites from committing fraud,” she continues. In response, the FDA said it created a dedicated task force and “developed new regulations and guidance further to improve the conduct of clinical trials and enhance the protection of people participating in clinical trials,” but deniedScience