Drugmakers are pushing the FDA to resume inspections halted by the pandemic after the agency has deferred or denied drug approvals because it couldn't inspect manufacturing plants in person, Politico reported March 2.
The FDA is required to regularly inspect drug manufacturing plants to ensure the safety of new drugs, as well as those already on the market. The inspections must take place before a new drug can be approved.
But the FDA halted inspections when the COVID-19 pandemic began last year. The agency conducted just 52 inspections in the U.S. between March 2020 and September 2020 compared to conducting about 400 during the same time period in 2018 and 2019, according to a Government Accountability Office report reviewed by Politico. The agency inspected just three plants outside the U.S. in the same time period in 2020 compared to 600 during that time period the previous two years.
The FDA said in July 2020 that it would resume domestic inspections, but only if it saw declines in new cases of COVID-19 and hospitalizations in the area it was asked to inspect.
The FDA has deferred or denied at least six drug approvals in recent weeks because it couldn't inspect manufacturing sites both in the U.S. and abroad, Politico reported. The drugs include a treatment for endometrial cancer, abnormally low levels of white blood cells, a regenerative skin therapy for adults with second-degree burns and a cholesterol drug for people who can't tolerate statins, according to Politico.
The Pharmaceutical Research and Manufacturers of America, the drug industry's largest lobbying organization, said in a December letter to the FDA that its current approach to inspections will "increase the risk of drug shortages in the global supply chain … and could delay availability of new therapies," Politico reported.
FDA spokesperson Jeremy Kahn told Politico the agency is performing "mission critical" inspections and using record reviews and outside regulator reports to supplement in-person visits when possible. He said the agency hasn't seen "a significant impact on its ability to take action on drug applications," but acknowledged the agency has deferred several drug applications due to the lack of inspections.
The FDA reportedly is considering virtual inspections using video and other tools. Drug regulators in the U.K., European Union, Canada and Australia are already conducting virtual inspections, according to Politico.
Stephen Schondelmeyer, PharmD, PhD, principal investigator for the University of Minnesota’s Center for Infectious Disease Research and Policy Resilient Drug Supply Project, told Politico he's worried about a significant increase in drug recalls for safety and effectiveness concerns because of the lack of inspections.
Diana Zuckerman, president of the National Center for Health Research, told Politico the issue also extends to medical devices. She said she's concerned about a lack of inspections for medical devices because they don't normally undergo clinical trials, so inspections are the main tool for assessing safety and effectiveness.
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