During a yearslong dip of the FDA inspecting clinical research in hospitals and other care sites, the U.S. Government Accountability Office said the agency should bolster its retention and recruitment efforts.
Since 2017, the number of FDA clinical research inspections have declined, and the frequency halved during the COVID-19 public health emergency, according to a March 25 GAO report.
"FDA has faced challenges recruiting and retaining investigators, resulting in fewer inspections and a less experienced workforce," the report said. "For example, FDA was unable to complete about 30% of one type of common inspection within the requested time frames from fiscal year 2018 through July 2023, according to agency information."
Bioresearch monitoring investigators also told the GAO they were frustrated because problems they found did not result in serious classifications.
To shorten the staff vacancies and increase clinical trial investigations, the GAO recommended the FDA consider increasing pay, repaying student loans and implementing other financial incentives.
"FDA agrees with GAO's recommendation and is currently developing on an action plan," an FDA spokesperson told Becker's.