HHS agreed with GAO’s recommendation to evaluate its recruitment and retention efforts to determine their effectiveness. Image: Tada Images/Shutterstock.com
By: FEDweek StaffA GAO report says that the FDA faces recruitment and retention issues that are common across government among its employees who inspect clinical research, limiting the agency’s capacity to perform such oversight.
Such inspections help ensure the quality and integrity of clinical research used to support drugs seeking marketing approval. Over 2012 through 2020, FDA classified 3 percent of clinical research inspections as having serious deficiencies that would warrant regulatory actions, it said.
“FDA has faced challenges recruiting and retaining investigators, resulting in fewer inspections and a less experienced workforce. For example, FDA was unable to complete about 30 percent of one type of common inspection within the requested time frames from fiscal year 2018 through July 2023, according to agency information. FDA officials and the investigators GAO spoke with identified low compensation and high amounts of travel as contributing to these challenges,” it said.
It said the agency “recently made progress recruiting new investigators” through use of incentives such as student loan repayments, “but attrition has been a persistent problem and it can take new investigators up to a year to independently conduct inspections.”
GAO added that in interviews, investigators “were frustrated that problems they identified (e.g., failure to follow research protocols) did not result in more serious classifications.” For example, it said, the agency FDA is limited in its ability to cite serious deficiencies for a common type of study supporting generic drugs because the regulations for these studies do not include certain requirements. The FDA has started the process of revising those regulations, it said.
The FDA’s parent department HHS agreed with GAO’s recommendation to evaluate its recruitment and retention efforts to determine their effectiveness.
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