FDA’s parent department HHS agreed with recommendations to develop action plans to address root causes of investigator attrition. Image: JHVEPhoto/Shutterstock.com
The FDA has taken steps to reduce vacancies among its cadre of employees who conduct n-person inspections of foreign and domestic drug manufacturers, but “attrition has generally outpaced hiring and has resulted in a large number of relatively inexperienced investigators,” the GAO has said.
“The continued loss of experienced investigators is already affecting FDA’s ability to meet inspection goals,” said a report, citing vacancies in about a fifth of those positions as of June of this year.
“FDA identified root causes of attrition as the frequency and conditions of travel, pay, insufficient training, heavy workload, and issues of work-life balance,” it added, but the agency has not yet developed action plans to address those issues.
The report noted that due to restrictions during the pandemic, the FDA expanded the use of alternative inspection tactics such as remote assessments and using trusted inspectors of foreign countries. It continues to use the latter but has cut back on the former, the GAO said.
FDA’s parent department HHS agreed with recommendations to develop action plans to address root causes of investigator attrition, balancing inspection needs against the need to retain investigators.
Earlier this year, the GAO reported similarly that the FDA faces recruitment and retention issues among its employees who inspect clinical research, “resulting in fewer inspections and a less experienced workforce” and limiting the agency’s capacity to perform such oversight.
That report also similarly said that while the agency has recently made progress recruiting new investigators through use of incentives such as student loan repayments, attrition has been a persistent problem and it can take new investigators up to a year to independently conduct inspections.
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