(HealthDay News) — The US Food and Drug Administration’s (FDA) oversight of clinical trials has been described by experts as “grossly inadequate,” according to an article published in The BMJ.

The FDA received complaints regarding problems at 3 Pfizer COVID-19 vaccine clinical sites, including falsified data, unblinded patients, and inadequately trained vaccinators who were slow to follow up on adverse events. However, the FDA did not inspect these trial sites.

Regulatory documents showed that before licensing the mRNA vaccine, only 9 of 153 Pfizer trial sites were subject to FDA inspection. Similarly, inspections were carried out on only 10 of 99 Moderna trial sites and 5 of 73 remdesivir trial sites. At the peak of the pandemic restrictions, the FDA paused site inspections instead of ramping up oversight since COVID-19 products were being developed rapidly.


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The FDA has a history of failing to oversee clinical sites adequately, with a 2007 report noting that the FDA audited less than 1% of the nation’s clinical trials sites between 2000 and 2005. Despite the estimated hundreds of thousands of clinical trial sites in operation, the FDA only has 89 inspectors who assure the quality and integrity of data submitted in support of new product approvals and marketing applications.

“The FDA was just yawning its way through the pandemic. The entire agency is broken,” David Gortler, a pharmacist and pharmacologist who worked as an FDA medical reviewer between 2007 and 2011, said in a statement.

The FDA said it takes oversight of clinical trials seriously and had adapted to travel restrictions, publishing and using draft guidance for remote regulatory assessments, which involved virtual inspections using live streaming and video conferencing and requests to view records remotely, according to a press release. The FDA also 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.”

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