New Study Finds FDA’s Inspection Pause May Have Compromised Drug Quality While Agency Says It's Ramping Back Up
The FDA's pausing its onsite inspections may have had negative consequences for drug quality, according to an analysis in Health Affairs. The agency said more inspections are coming.
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A recent analysis published in Health Affairs suggests that the FDA’s decision to halt on-site inspections during the COVID-19 pandemic temporarily may have resulted in negative consequences for drug quality.
The study, led by Emily Cuddy, an assistant professor of economics at Duke University, examined the number of drug quality inspections conducted by the FDA Office of Regulatory Affairs (ORA) from 2012 to 2022. It analyzed inspection outcomes in five regions, including China, Europe, India, Latin America, and other foreign nations, to determine if firms required improvements in their quality standards (classified as Official Action Indicated (OAI)).
Recent decline in inspections
The researchers found a 79% decrease in foreign inspections and a 35% decline in domestic inspections in 2022 compared with 2019. Yet during this time, the share of inspections resulting in an OAI dramatically increased, from 14% of domestic inspections and 9% of foreign inspections in 2019 to a doubling of both numbers in 2021.
Cuddy and colleagues wrote:
“Deferring inspections for operational establishments may have consequences. Increases in time elapsed since the last inspection are associated with decreases in regulatory adherence. As these inspections play a crucial role in upholding manufacturing standards, the delay could have exposed US consumers to lower-quality products.”
Change in inspection criteria during the pandemic
The authors suggest that a shift in the criteria used by the FDA to select sites for onsite inspections may be the reason for the higher number of OAI findings during the COVID-19 pandemic. According to the analysis, establishments that were inspected during the pandemic were almost twice as likely to have had a history of objectionable conditions or practices compared to those that weren’t inspected. Yet, Cuddy and colleagues wrote that the FDA’s decision to pre-announce inspections during the pandemic and give “bad actor” firms a chance to “hide quality issues” does not explain the increase in the OAI rate.
Ongoing suspension of foreign inspections
The researchers also pointed out that although travel restrictions are no longer an issue, most foreign inspections are still suspended. They believe it's difficult to justify continuing to delay foreign inspections due to the available data. As the world continues to emerge from the pandemic, it’s crucial for the FDA to deal with the inspection backlog and explore new approaches for the future, according to their report.
The researchers also noted that while travel restrictions are no longer a concern, most foreign inspections still remain on hold:
“It is hard to rationalize continuing to postpone foreign inspections, given the data available to us. As the world moves beyond the pandemic, it is crucial for the FDA to address the backlog of inspections and to consider new approaches for the future.”
Recommendations for future FDA actions
They recommend that the FDA prioritize foreign inspections in an effort to “close the foreign-domestic inspection disparity that COVID-19 reopened.”
Other recommendations include:
Increasing international cooperation through the use of mutual recognition agreements that recognize inspection reports made by overseas regulators.
Increasing the use of third parties to assess drug quality.
Increasing patients’ awareness of drug quality issues.
“Few know that foreign drug production sites are rarely inspected by the FDA and receive advance warning before an inspection,” Cuddy and colleagues wrote. “If patients were made aware of average quality differences across manufacturers of generic drugs, then they could make quality-informed purchase decisions.”
FDA says more inspections are coming
Just days after this analysis was published looking at the FDA’s pandemic problems, a report in RAPS indicated a significant shift in the FDA's approach — ramping up its onsite surveillance inspections, both domestically and internationally. This marks a decisive move toward returning to pre-pandemic regulatory oversight levels.
A few takeaways from that report:
Increasing inspection numbers: The numbers reported by Douglas Stearn at the FDLI meeting show a gradual but consistent increase in both domestic and foreign inspections.
Utilizing FDORA for efficient inspections: The FDA is also leveraging the Food and Drug Omnibus Reform Act of 2022 (FDORA) to inspect sites virtually and use records requests to resolve deficiencies. This approach allows the FDA to conduct more efficient inspections and address the backlog without compromising on the quality of oversight.
Challenges in workforce specialization: The demand for specialized inspectors familiar with new and complex products presents an ongoing challenge for the FDA. But the agency says its actively working to build a workforce with the necessary expertise, indicating a forward-looking approach to regulatory inspections.
Pending ORA reorganization for enhanced efficiency: The proposed major reorganization of the ORA is set to enable more streamlined and nimble decision-making. This reorganization is expected to positively impact the efficiency and effectiveness of FDA inspections, allowing the agency to better respond to crises and ensure drug quality.
Overall, contrasting the Health Affairs report with the recent update, it’s evident that the FDA is making a progressive shift. While the pandemic posed significant challenges, the FDA's current efforts and future plans suggest a more robust response through more frequent, efficient, and specialized inspections.
Are you inspection-ready?
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