FDA Defends Training/Support of Team Biologics
FDA is defending criticism (see earlier story) from three former FDA Team Biologics inspectors who left the agency over working conditions and a lack of training, which they claim leaves the team with inspectors ill-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.
FDA spokeswoman Audra Harrison told FDA Webview 12/7 that the agency, like the rest of the world, had to “rapidly adapt operations to the Covid-19 pandemic while ensuring that the appropriate trainings were available to current and newer staff. Staff turnover in public health is high and the 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 FDA “provides its investigators with numerous resources to support inspections and investigations, including continuous advanced instruction and training. Our investigators have continued to conduct inspections and investigations of manufacturers of critical medical products, including vaccines for Covid-19 and the important work in support of the U.S. government’s response to the monkeypox public health emergency.” Each Team Biologics member must have prior investigative experience, and the agency uses virtual video training to provide the initial instruction, and then it conducts on-the-job training with senior experienced professionals “before assigning independent, complex work assignments,” she added.
Addressing criticism from the former investigators about a lack of in-person training, FDA has indicated that because of Covid, the agency as a whole “had limited in-person classroom training opportunities. We provided, and continue to provide, employees with in-person and virtual training opportunities through external vendors, internal offerings and through workshop and conference participation. We also provide on-the-job training while conducting inspections as an essential component of investigator development… Additionally, we are updating our trainings to incorporate modernized approaches to improve effectiveness and efficiencies across our investigator programs.”
FDA has also said it provides Team Biologics’ investigators with numerous resources to support inspections and investigations, including basic drug school, industrial sterilization and aseptic processing. Investigators are also “developed through a combination of seminars and workshops, on demand training modules, on-the-job training during inspections and hands-on experiential training in specialized facilities,” it adds.
Additionally, FDA noted that at the end of fiscal year 2022, there were 14 Team Biologics investigators onboard and ORA has added six additional vacancies to the team to be filled next year. The agency’s fiscal year 2023 budget request seeks an additional $24 million for its inspection program to catch up on postponed surveillance inspections and maintain the staff it hired with supplemental funding received under the Covid emergency. It said the additional monies will help it increase the foreign inspection cadre, allow greater oversight of domestic and foreign manufacturers, in addition to further hiring investigators, laboratory analysts, information technology and data analytics staff.