Training in the Food and Drug Administration’s office that oversees licensed vaccines has decreased dramatically in recent years, raising concerns that the team is not equipped to identify quality control issues in manufacturing
When the FDA hired people onto Team Biologics during the early years after its formation, inspectors were required to go through a series of training programs, including training that educated inspectors about aseptic processing. | Sarah Silbiger/Getty Images, according to three former inspectors.
Audra Harrison, a spokesperson for the FDA, said the inspectors on Team Biologics are “highly trained professionals” who produce thorough assessments of each facility during inspection. However, close to half of the inspectors on the team have not received the training that they need to identify missteps or abnormalities in manufacturing when visiting facilities — a critical step in ensuring the products are safe for use once released to the market, the former inspectors said.
But even as the urgency of the office’s work increased — with all Americans eligible for Covid-19 vaccinations — it suffered from a continued loss of veteran inspectors. or no prior experience working with biological drug products started going on inspections of those manufacturing facilities. The former inspectors said the unspecified promise of additional training while blaming the pandemic for staff turnover carries a familiar echo.
. The complaint detailed a scenario in which an inspector, Arie Menachem, flagged unsafe practices at a Merck manufacturing facility only to have his supervisor downplay his findingsBut the training issues described by the former inspectors are far more extensive than previously understood and have persisted, according to the former inspectors.
Executives in the pharmaceutical industry — including those that work in vaccine facilities — have begun to pick up on the lack of training, according to a person familiar with the matter who has worked with several high-profile vaccine manufacturers. Many of the products overseen by Team Biologics are manufactured using aseptic processing, a specific system that produces sterile injectable products.
“[Some of] the newer hires have … not even attended basic drug school,” the second former inspector said, adding that they had also not completed nearly as many hours of rigorous training as those who were hired after Team Biologics formed.“It was intense. And you had to pass things by 90 percent or so. If you didn’t, you had to retake,” the former inspector said. “Then every year thereafter we had to go to headquarters where we were retrained on whatever is new.
The newer staff were also 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, one of the former inspectors said. Over the last several years, particularly since the pandemic began, the newer hires on Team Biologics have, on average, issued fewer Form 483s — documents thatduring inspections such as instances where manufacturing staff improperly handled drug substances or a facility having unsanitary equipment, the former inspectors said.
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