Team Biologics Needs More Staff, Training: Former FDAers
Three former FDA Team Biologics inspectors who left the agency in recent years due to frustration over working conditions, say needed training for team members has decreased dramatically in recent years, leading to concerns that inspectors are not equipped to identify manufacturing quality control issues. The inspectors were granted anonymity for a lengthy online Politico story. They said that in recent years multiple inspectors have left the team, citing internal frustrations over the lack of training and concern that supervisors had little knowledge of the complexities associated with the inspections they oversee.
While all three former inspectors said they were unaware of any instances in which Team Biologics accidentally missed contamination of a vaccine or failed to report a manufacturing issue, they still were concerned about inspectors misidentifying a problem or overlooking a serious issue if more rigorous training is not reinstated and experienced inspectors are not brought on to the team.
Agency spokesperson Audra Harrison told Politico that Team Biologics inspectors are “highly trained professionals” who produce thorough assessments of each facility during inspections. “FDA’s highest priority is protecting public health and, as an agency, that commitment is firm in the best of times or when facing a global pandemic,” Harrison said. “The American public can and should be confident that they remain our foremost concern.”
Politico also interviewed former FDA acting principal deputy commissioner John Taylor, who said “the very reason Team Biologics was formed the way it was formed is because the substance is very complex and we wanted people who were hyper-specialized, and if they need to get additional training, you would train the cadre and keep them up to speed. If training is diminishing and/or the experience level of the people joining is diminishing then I can see that being a problem.”
Harrison said the agency recognizes the need to build out its inspection staff and said it is pushing to expand the educational opportunities it offers employees. “Staff turnover in public health is high and FDA is not immune to these conditions, particularly the biologics staff who have been working on two public health emergencies while keeping the normal cadence of agency business moving forward,” Harrison said.
The former inspectors said some of the issues arose from a 2017 reorganization that had Team Biologics merge with a team that worked on unlicensed blood and tissue products. They said the reorganization complicated the work because new supervisors did not have experience with complex biological drug inspections. In the years that followed, they said, new inspectors from the merged team and new hires did not have the experience necessary for inspecting biological drug products. A former inspector also said the new inspectors were never enrolled in the same training programs as their veteran colleagues had completed, making it difficult for them to actively participate in inspections outside of completing basic, administrative tasks.