The FDA is conducting fewer inspections of clinical trial research sites, according to a Government…
Children's Health Defense By
The U.S. Food and Drug Administration (FDA) is conducting fewer inspections of clinical trial research sites than in past years, according to a recent report by the Government Accountability Office (GAO).
FDA officials attributed the decrease to the COVID-19 pandemic and a shortage of investigators, the federal watchdog said.
In preparing its report — which Congress commissioned — the GAO looked at FDA data and documents from fiscal years 2012 through 2023. It also interviewed an undisclosed number of FDA officials and 15 FDA investigators.
Investigative journalist Maryanne Demasi said she found the decrease in clinical research inspections “concerning.”
Demasi — who in 2022 published an investigation in The BMJ that found the FDA’s oversight in 2020 of COVID-19 vaccine clinical trials was “grossly inadequate” — told The Defender, “It appears that little has changed.”
The FDA’s lack of oversight is a big problem because the public relies on the quality and integrity of clinical trial data to ensure the safety of approved drugs, she said. “If the FDA drops the ball, as it appears to have done in the past few years, it puts people’s lives at risk.”
According to the GAO report, many FDA inspectors were frustrated, saying the agency often ignored their recommendations to take regulatory action when their inspections showed clinical research sites were out of compliance.
This is similar to what Demasi found during the COVID-19 clinical trials.
As she reported in The BMJ, a regional director overseeing Pfizer’s COVID-19 mRNA vaccine complained to an FDA inspector about a range of problems including falsified data, unblinded patients and inadequately trained vaccinators who were slow to follow up on adverse events.
“I thought that the FDA was going to swoop in and take care of everything,” the regional director told The BMJ. “What I was reporting was so important.” But the FDA did not inspect the trial sites in question.
Clinical research entities not being held accountable
According to the GAO, six of the 15 investigators said they felt clinical research entities weren’t being held accountable for the concerning observations made during inspections.
From fiscal years 2012 through 2020, the FDA classified only 3% of clinical research inspections as having serious deficiencies that would warrant regulatory actions.
This small figure is partly because the FDA downgraded more than half of the inspections completed in those years — meaning that although the inspectors initially classified the problems they found during their inspection as big enough to warrant official action, the FDA changed that to a less serious classification that didn’t require FDA action.
An example of official action is the FDA sending a warning letter to the clinical research site for not following study protocols by improperly enrolling subjects that didn’t meet eligibility requirements, or improperly administering doses of the study drug outside the required schedule, according to the GAO.
The FDA’s downgrading of the inspectors’ classifications frustrated the inspectors and affected their morale, the GAO said.
FDA inspectors take higher-paying jobs in drug industry
Relatively low pay also frustrated inspectors which, in turn, led to retention challenges. For example, two investigators who spoke with the GAO left the FDA for higher-paying industry jobs…
READ FULL ARTICLE HERE… (childrenshealthdefense.org)
Home | Caravan to Midnight (zutalk.com)
