ORA head says attrition is outpacing hiring, decries flat funding for inspections
Inspectors are leaving the US Food and Drug Administration (FDA) at a faster rate than they can be replaced as they retire or pursue other opportunities. In addition, FDA’s budget for inspections in the medical product area is not keeping up with the workload, said Judith McMeekin, FDA associate commissioner for regulatory affairs within the Office of Regulatory Affairs (ORA).McMeekin delivered these remarks during a 14 April webinar sponsored by the Alliance for a Stronger FDA. She also announced her plans to retire, effective 30 June. She will be replaced on an acting basis by Carol Cave, who is currently the deputy associate commissioner for regulatory affairs until a permanent replacement is found.
During her presentation, McMeekin highlighted some of the agency’s recruitment and retention challenges, a theme repeated earlier by biologics center director Peter Marks earlier this month. (RELATED: CBER chief discusses hiring and retention challenges brought on by remote work, Regulatory Focus 6 April 2023)
“One of our biggest challenges, and a major priority for ORA, is hiring new investigators and retaining them. Unfortunately, our hiring and recruitment tools cannot keep pace with our rate of attrition as investigators pursue other opportunities in the federal government or the private sector. In fact, 22% of ORA’s total workforce is eligible to retire today,” McMeekin said.
One challenge in recruiting is the nature of the work involved as an inspector, who must travel from FDA to multiple countries, while one inspection can last for several weeks. When an issue arises, these trips need to be extended.
McMeekin said that she appreciates the additional funding from Congress to hire staff through the Title 21 of the 21st Century Cures Act which will “allow us to maintain the additional investigators we had hired through our COVID supplemental funding.”
However, McMeekin said that congressional funding has not kept pace with the inspectional workload for medical products. “Unfortunately, while the medical product centers have received increased funding over the years, funding for ORA’s medical and inspection work has remained flat. Over the past eight years, from FY 2015 through 2023, ORA’s biological programs have received only $9 million in increases.” She added that FDA’s medical device program “received only 14.8 million increases over the past eight years.” In comparison, funding for human and animal food has increased by $209 million over the past eight years.
McMeekin said that "in the long term, FDA needs to have its budget keep pace with our work."
McMeekin also addressed the pending ORA reorganization but offered few specifics beyond what was earlier provided by FDA officials. (RELATED: Woodcock: Pending ORA reorg will ‘modify things significantly’ for all FDA regulated products, Regulatory Focus 3 March 2023)
“This proposal will aim to improve the risk prioritization and public health impact of our field activities allowing us to make a more prevention-based approach to product safety and inspections, it also focuses on our core mission.” She added that “for far long, data silo workflows have hampered our efforts to modernize inspectional work.”
During a question-and-answer period, McMeekin was asked whether ORA would be resuming its pre-pandemic level of inspections. She responded that “the good news is that our inspection plans and forecasting have turned to pre-pandemic levels, in FY 2023, we made significant progress in reducing the backlog of inspections that were postponed during the pandemic.”
She added that “I would like to say that we have never stopped inspecting throughout this time, while we did postpose surveillance inspections due to the risk of our staff and the employees at facilities, we continue using a risk-based approach to foreign and domestic inspections.”
Alliance for a Stronger FDA
