Drugs

Pressing Need for Alternative Inspections: Researchers

Researchers from Duke University and the University of Maryland say there is a “pressing need” to explore alternative methods for inspecting overseas and domestic drug manufacturing facilities to help keep an eye on drug quality.

The early Covid-19 pandemic period saw FDA pausing inspections of most domestic and overseas drug manufacturing establishments. “Looking at data from the period 2012–22, we observed steep declines in both foreign and domestic inspections in 2020,” the researchers wrote in the December issue of Health Affairs. “By 2022, numbers of inspections remained well below prepandemic levels, with a 79% decrease in foreign inspections and a 35% decline in domestic inspections compared with 2019… Also, the resources allocated per inspection surged, although the FDA’s overall budget and staffing remained steady. Finally, citations rose dramatically, despite all establishments being given advance notice of inspections.”

The researchers contend that as the world moves beyond the pandemic, it is critical for FDA to address its backlog of inspections and consider new approaches for the future. They also offered the following five recommendations:

Hire more FDA investigators: Congress should give the agency more flexibility to hire. “More staff can enable more inspections, shorter lags between inspections, and investigator rotation across different establishments, which is essential to counteract complacency arising from repeat visits by the same inspector,” the researchers wrote.
Prioritize foreign inspections: This would close the foreign-domestic inspection disparity that Covid-19 reopened.
Increase international cooperation: FDA should continue to use and expand mutual recognition agreements that recognize inspection reports and product sampling programs by foreign regulatory authorities. “Furthermore, the FDA should continue to ask for records before or instead of conducting on-site inspections and to use technology such as video calls and screen sharing for reviewing data from inaccessible establishments,” the researchers said. “Nevertheless, these efforts should supplement, and not be substitutes for, in-person inspections abroad going forward.”
Share the burden for drug quality assurance: “For instance, both Kaiser Permanente and the Department of Defense are now working with a laboratory to test drugs and choose their producers based on quality,” they said. “Other intermediaries, such as wholesalers and retailers, should follow suit.”
Increase patients’ drug quality awareness: Because few patients know that foreign manufacturing sites are not inspected as often as domestic sites, they should be “made aware of average quality differences across manufacturers of generic drugs, then they could make quality-informed purchase decisions,” the researchers wrote.

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