BMF Investigation: FDA oversight of clinical trials is “grossly inadequate,” say experts

“Regulatory documents show that only nine out of 153 Pfizer trial sites were subject to FDA inspection before licensing the mRNA vaccine. Similarly, only 10 out of 99 Moderna trial sites and five of 73 remdesivir trial sites were inspected.

Now, facing a backlog of site inspections, experts have criticised the FDA’s oversight of clinical trials, describing it as ‘grossly inadequate.’ They say the problem, which predated covid-19, is not limited to a lack of inspections but also includes failing to notify the public or scientific journals when violations are identified—effectively keeping scientific misconduct from the medical establishment.

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 was then appointed as a senior adviser to the FDA commissioner in 2019-21…
 
Paused during the pandemic
 
Between March and July 2020, at the peak of pandemic restrictions, the FDA paused its site inspections and only ‘mission critical’ inspections were carried out. Gortler says, however, that this was the time that the FDA should have ramped up its oversight, not scaled back, especially since covid-19 products were being developed at warp speed and intended for millions of people…
 
Historical failure to oversee

The FDA has a long history of failing adequately to oversee clinical trial sites. A report in 2007 by the Department of Health and Human Services’ Office of the Inspector General found the FDA audited less than 1% of the nation’s clinical trial sites between 2000 and 2005 ..
 
In 2015, Charles Seife, professor of journalism at New York University, conducted an analysis of published clinical trials between 1998 and 2013 in which an FDA inspection found significant evidence of objectionable practices. A total of 57 published clinical trials had significant evidence of one or more problems: 39% had falsification or submission of false information, 25% had problems with adverse events reporting, 74% had protocol violations, 61% had inadequate or inaccurate recordkeeping, and 53% failed to protect the safety of patients or had problems with oversight or informed consent. Furthermore, only 4% of the trials that were found to have significant violations were mentioned in the study’s journal publications.”