28/29 September 2022
Since the beginning of the pandemic and the associated travel restrictions, the FDA has been hesitant to decide whether and, if so, how to conduct distant assessments or remote inspections of drug establishments. Other regulatory agencies have already introduced distant assessments - be it on a national or even international level. Now, more and more criticism is spreading, as an opinion piece published in Bloomberg News shows.
Here, Mark I. Schwartz of Hyman, Phelps & McNamara P.C and author of the article, criticises the agency's failure to develop an alternative to on-site inspections during the pandemic. Without these inspections, new and modern therapies may be put on hold or even rejected, and there may be drug shortages, including for drugs used to treat Covid 19 patients.
As an example, the FDA in November deferred an application from Bristol Myers Squibb (BMS) for Liso-cel, a CAR-T cell therapy for treating adults with large B-cell lymphoma. BMS reported that "the pandemic prevented agency investigators from traveling to a facility in Houston involved in the manufacture of the drug", despite the fact that the plant was classified as "mission critical" by the agency's definition and the FDA therefore should have conducted an inspection even tough the pandemic.
"Back in August, the FDA had issued guidance emphasising that it intends to use "other tools" to determine the compliance status of drug facilities that cannot be inspected on-site". However, the author notes that none of these other tools seem to have been used - neither at BMS nor at other manufacturers.
One option, for example, would have been a distant assessment (or remote inspection). Here, audio and video equipment can be used not only for communication but also to inspect documents and even entire facilities. Unfortunately, despite offers from industry to provide technical support, the FDA has not announced any plans to introduce such distant assessments.