With Life-Saving Meds on the Line, FDA Doubles Down on Inspection Goal
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The U.S. Food and Drug Administration (FDA) is making up for Covid-lost time this year, doubling the goal for FY 2021 domestic surveillance inspections for food and medical manufacturing facilities.
In March of 2020, manufacturing site inspections all but came to a halt in an effort to protect agency investigators from coronavirus exposure. This past spring, the agency put out a “Resiliency Roadmap” with an outline to make up for lost time on the more than 15,000 domestic inspections of both food and medical products. About 3,229 of those inspections were for medical products.
Only 52 inspections were completed between March and September 2020, compared to about 400 over that same time period in each of the previous two years. Pharmaceutical companies bore down on the FDA, pushing for a solution to the inspection delays. Drug lobbyist PhRMA posted a letter sent to the agency warning that its current approach of avoiding inspections “will increase the risk of drug shortages in the global supply chain … and could delay availability of new therapies.”
The FDA's Resiliency Roadmap plan estimated that about 14% of the delayed inspections (about 2,100) could be accomplished this year in an effort to return to normal. Instead, the agency announced it managed to conduct a total of 4,849 in FY 2021.
The delayed inspections came with a price for patients. When it released its “roadmap,” the FDA indicated that 68 applications for medical products were "delayed solely due to a pending inspection or facility assessment.” Seven of these applications were deemed “mission critical.”
"As of September 30, 2021, FDA conducted inspections or facility assessments that supported decisions for 30 of these delayed applications, including all seven mission-critical applications. Additionally, five of those applications outlined in the Roadmap are no longer delayed solely due to a pending inspection or facility assessment, as other factors have contributed to the delay," FDA says.
Applications have continued pouring in, so as of September 30th, there are now 60 applications facing delays due to a pending inspection.
Foreign inspections have faced even greater delays with the pandemic-induced travel restrictions. Between April and September of this year, the agency completed 74 medical facility inspections abroad.
Virtual inspections have been explored by the agency to lessen the travel and exposure load of its investigators. According to the agency, by using video and other tools, it may be possible to “remotely evaluate a facility by viewing livestreaming video of operations and other live interactions designed to simulate as closely as possible what happens during an actual inspection.” However, no timeline has been given for virtual inspections at this point.
As the pandemic state brought us vaccines and treatments at the “speed of science,” it’s interesting to note that FDA prior-approval inspections are not required in the case of Emergency Use Authorization drugs or biologics. That’s why the COVID-targeting products did not face these inspection-induced delays.
FDA officials reassure that no corners were cut, of course, in the name of public health and the companies with EUA-approved products had to submit full information on the manufacturing process and quality control ops. But in-person site inspections are not required until the full approval application is filed. Officials may take other steps to ensure quality production.