Lawmakers raise concerns over COVID-19 impact on FDA foreign drug inspection program

Jul 22, 2021
Press Release
Suspension of in-person inspections at overseas manufacturing facilities has raised concerns about the agency’s ability to ensure the safety of Americans’ prescription medications

WASHINGTON, D.C. – A bipartisan group of lawmakers, including U.S. Rep. Diana DeGette (D-CO) – who chairs the House Energy and Commerce Committee’s Oversight and Investigations panel – sent a letter to the head of FDA today raising concerns about the impact that the ongoing COVID-19 pandemic is having on the agency’s ability to ensure the safety of prescription medications coming into the U.S.

In the letter sent to Acting FDA Commissioner Janet Woodcock, the lawmakers cited a substantial backlog of FDA inspections at foreign drug manufacturing facilities that’s been caused by the suspension of in-person visits to such facilities during the pandemic; and want to know what the agency plans to do to address the issue to ensure the safety of Americans’ prescription medications.

“While we understand that the emergence of COVID-19 required the agency to suspend in-person inspection activities temporarily, we remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” the lawmakers wrote.

According to a January 2021 Government Accountability Office report, FDA inspections of both foreign and domestic manufacturing facilities in 2020 were reduced by 56 percent compared to the number of inspections performed during the previous two fiscal years. 

Further, FDA reported conducting only three foreign so-called mission-critical inspections from March to October 2020, significantly less than the average of 600 foreign inspections conducted during that time period in previous years.

While data recently reported by FDA indicates that there has been an increase in the number of inspections of foreign and domestic establishments conducted since GAO’s findings were released, the agency’s May 2021 Resiliency Roadmap report states that even under a best-case scenario FDA would only be able to complete 50 percent of its remaining domestic-facility inspections planned for this year, while its in-person inspections of foreign facilities would remain limited to only those dubbed mission-critical through 2021.

Congress has given FDA authority to utilize alternative methods to help address the postponement of most in-person inspections, including allowing the agency to utilize records requests in lieu of certain in-person visits and recognizing inspections conducted by foreign governments or agencies in lieu of their own.

Meanwhile, FDA has released its own guidance on which activities it’s willing to conduct remotely during the ongoing pandemic, but lawmakers are concerned the agency has not yet shown how those activities, alone, are able to substitute the need for in-person visits to help alleviate the backlog during the pandemic.

“While we are pleased that the agency has demonstrated the usefulness of these alternative tools in supplementing inspection activities, it is largely unclear for which types of inspections, if any, FDA can appropriately use these alternatives as a full substitute for an in-person inspection,” the lawmakers wrote. “Furthermore, GAO has stated that FDA will face future challenges with its drug approval and surveillance oversight activities if inspection delays continue.”

In addition to DeGette, the letter was signed by U.S. Reps. Frank Pallone, Jr. (D-NJ), Cathy McMorris Rodgers (R-WA), Anna G. Eshoo (D-CA), Brett Guthrie (R-KY) and Morgan Griffith (R-VA) – all of whom serve as the top Democrat or Republican on key House panels that oversee the agency.

The lawmakers requested that Woodcock provide the committee more information on FDA’s plans to mitigate the inspection delays by August 5, 2021.

A copy of the lawmakers’ letter to Woodcock is available here.