Inspection Disruptions Won’t Rise to Covid Level: Expert
The recent FDA reductions in force involving leadership, inspection administration, and travel logistical planners has been incredibly disruptive to the inspection cadre, but they do not rise to the level of disruption that was caused by the Covid-19 pandemic, former CDER Office of Compliance director (retired 2022) and now Eliquent Life Sciences consultant Don Ashley told a Food and Drug Law Institute Webinar 5/1. While he predicted that the agency will not see a Covid-equivalent level of disruption, he said it is likely that fewer inspections will occur this year. And this means FDA’s Office of Inspections and Investigations will work with its partners and the different medical product Centers to reprioritize planned inspections according to the highest level of public risk and the need to support new product applications.
“Now, I do think that it’s highly likely that FDA is going to need to postpone surveillance inspections for facilities, including drug facilities considered to present a lower level of risk, typically based primarily on the type of products manufactured, but other factors as well,” Ashley said. “And as a result, it’s likely that we may see increases to the number of FDA-regulated facilities that haven’t been inspected before or haven’t been inspected in the last five years.” To compensate for fewer surveillance inspections and as it did during Covid, FDA is likely to increase the utilization of record requests and other inspection alternatives, he added.
During his talk, Ashley noted that foreign inspections are a high priority for FDA commissioner Marty Makary, particularly unannounced inspections. Makary has questioned the current status quo of pre-announced inspections for foreign drug manufacturers, which he believes hold them to a lower inspection standard. On 5/6 and as predicted, Makary announced that the agency will expand unannounced inspections at foreign manufacturing facilities (see story).
Additionally, Ashley doesn’t expect there to be any changes to pre-approval and pre-licensure inspection programs, which he believes will remain a priority at FDA because they are necessary to meet the user fee commitments. “If necessary, FDA is going to utilize alternative inspection tools or other strategies, the same ones that they very successfully employed during the Covid-19 pandemic to compensate for a substantially lower level of inspection capacity at that time and still meet user fee goals,” he said.
Ashley’s advice for companies is to maintain inspection readiness, and to treat any record request that is received with the same level of seriousness that is used when preparing for an inspection or when responding to a Form FDA-483. “When I was the CDER Office of Compliance director, we frequently issued Warning Letters in response to the information received through these record requests,” he said, adding that poorly prepared responses increase the chances of receiving a letter.