Companies Push FDA to Solve Inspection Delays: Report

Drug companies are pressing FDA to find ways to resolve the inspection backlog that has occurred due to Covid 19. Politico reports in an online post that between 3/2020 and 9/2020 FDA inspected just three overseas plants (well below the 600-plus visited in each of the prior two years) and conducted only 52 U.S. inspections (down from about 400 in 2018 and 2019).

“Inspections, which are required before a therapy wins FDA approval, are a vital tool to ensure the safety of new drugs as well as medicines already on the market,” the post says. “The effects of the FDA slowdown are already becoming apparent. In recent weeks, the agency has deferred or denied at least six drug approvals because it could not inspect manufacturing sites in the U.S. and abroad…. With no end to the pandemic in sight, pharmaceutical companies are bearing down on FDA to find a solution to the inspection issue.”

The article quotes former FDAer Mark Schwartz, now an attorney with Hyman, Phelps & McNamara, that “the agency doesn’t really seem to care and we are now approaching the one year point. It is irresponsible for the gold standard of regulatory bodies to be dithering while pharma is burning.”

FDA spokesperson Jeremy Kahn told Politico the agency continues to perform “mission-critical” inspections and is using record reviews and outside regulator reports to replace in-person visits when possible. He said that while several applications have been deferred due to the lack of inspections, FDA has not experienced “a significant impact on its ability to take action on drug applications.”

The agency reportedly is considering the possibility of conducting “virtual inspections” through video and other tools, something that is already underway in the UK, European Union, Canada, and Australia.

“FDA says they’re continuing to think about it, and while they’re thinking about it, in May of last year the British regulatory authority had already started virtual inspections,” Schwartz said. “Firms are forced to wait and some companies might go bankrupt because they’re one- or two-product companies.

From the University of Minnesota Center for Infectious Disease Research and Policy Resilient Drug Supply Project, Stephen Schondelmeyer told Politico that drug shortages caused by the inspection backlog are a real threat and FDA must do more. He said he worries about a major increase in drug recalls for safety and effectiveness reasons due to the lapse in inspections performed.

“I fully acknowledge the challenge of Covid-19 era inspections,” Schondelmeyer said, “but almost every other industry has found a way to continue operating and to function within these parameters of low social contact. When you have bona fide, effective new therapies that aren’t getting to market, that has an impact on patients.”