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FDA Oversight of Clinical Trials Described as ‘Grossly Inadequate’


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Last Updated: November 17, 2022.

By Elana Gotkine HealthDay Reporter

THURSDAY, Nov. 17, 2022 (HealthDay News) — The U.S. Food and Drug Administration oversight of clinical trials has been described by experts as “grossly inadequate,” according to an article published online Nov. 16 in The BMJ.

Following complaints to the FDA relating to problems at three Pfizer COVID-19 vaccine clinical sites reported by an overseer, including falsified data, unblinded patients, and inadequately trained vaccinators who were slow to follow up on adverse events, Maryanne Demasi, an investigative journalist based in Sydney, describes inadequate oversight in relation to development of the COVID-19 vaccine and predating the pandemic.

Regulatory documents showed that before licensing the mRNA vaccine, only nine of 153 Pfizer trial sites were subject to FDA inspection; similarly, inspections were carried out on only 10 of 99 Moderna trial sites and five 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. The FDA has a history of failing to oversee clinical sites adequately, with a 2007 report noting that the FDA audited less than 1 percent of the nation’s clinical trials sites between 2000 and 2005. In response to this report, a dedicated task force was established, although the request for an interview with a task force member was denied. 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. Although inspection reports are published, the database is not comprehensive and reports are not disclosed proactively, according to Demasi.

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FDA said it takes oversight of clinical trials seriously and had adapted to travel restrictions, publishing and using draft guidance for remote regulatory assessments, which involved virtual inspections using live streaming and video conferencing and requests to view records remotely,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