FDA Safety Inspections Falling Further Behind Due To COVID-19 Pandemic, GAO Report Warns
While federal regulatory agencies continue to limit travel during the COVID-19 pandemic, a new government watchdog report warns that the U.S. Food and Drug Administration (FDA) has fallen even further behind on thousands of routine safety inspections, leaving virtually all products and goods circulating through United States going unchecked.
The U.S. Government Accountability Office (GAO) released a new report this month, raising concerns over the FDA largely pausing foreign and domestic inspections since the beginning of the COVID-19 pandemic early last year, indicating that only three foreign inspections were conducted in fiscal year 2020.
The FDA is tasked with protecting public health by ensuring the safety of our nation’s food supply, cosmetics, veterinary drugs, biological products, medications and medical devices. This regulatory oversight calls for routine inspections of manufacturing facilities and production plants, to identify either defective or potentially harmful products and prevent them from reaching consumers.
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Since March 2020, the FDA has been forced to comply with the U.S. Centers for Disease Control and Prevention’s (CDC) COVID-19 guidelines in restricting travel, and has been honoring lockdown rules to protect staff members, leaving many facilities unseen and unchecked, according to the GAO report.
When the pandemic first began, the FDA stated that it would only continue conducting inspections for facilities and products deemed mission critical. GAO officials indicate this has resulted in a significant backlog of necessary inspections for critical devices and products, which could cause serious harm for consumers.
Highlighted in the report is the lack foreign drug manufacturing oversight, which has been a difficult task to handle even prior to the pandemic due to vacancies and language barriers, according to the report.
The FDA traditionally expects each investigator to perform 15 foreign drug facility inspections annually. However, the GAO report indicates the FDA performed a total of three foreign drug facility inspections over the entire 2020 calendar year. While the agency has been able use alternative inspection tools, such as having foreign regulators conduct site visits, review samples, and perform drug testing, GOA indicates the overall inspections and tools used are useful but not equivalent.
GAO investigators indicate that the FDA has also been unable to complete more than 1,000 of its planned fiscal year 2020 inspections and will likely face a backlog of inspections in future years
With no clear timeframe as to when normal FDA inspection operations may resume due to the ongoing COVID-19 pandemic, the GAO released a series of recommendations for the agency in January. Those recommendations included the FDA to ensure that inspection plans for future fiscal years respond to the issues presented by the backlog, and that the FDA asses the viability of the current alternative inspection tools. The FDA reportedly concurred with both recommendations.
The FDA routinely inspects approximately 160 facilities per month and on average, recalls approximately 4,500 drugs, devices and food products from U.S. shelves each year.
Although not to the scale of the pandemic, the FDA witnessed a similar inability to perform routine and necessary inspections during the Trump administrations government shutdown in January 2019.
Acting FDA commissioner at the time, Scott Gottlieb, warned that as a result of the shutdown which furloughed hundreds of food and drug safety inspectors, almost all domestic food products went largely unchecked, potentially allowing some of the most prevalent foodborne illnesses, such as Listeria, Salmonella and E. coli to circulate in the U.S. food market.
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