Right after the FDA said it was resuming domestic drug inspections—with a view to rev up foreign inspections in April—the U.S. Government Accountability Office (GAO) said the regulator still has work to do to overhaul its oversight mission abroad.
To tackle three big hurdles facing its inspection work overseas, the FDA needs to develop “tailored strategies and time frames” to recruit investigators for its foreign inspection workforce, the GAO said Monday. Likewise, the regulator should adopt a pilot plan for unannounced foreign inspections and for the use of independent translation services abroad.
GAO’s issue with the FDA’s foreign inspection program is threefold: First, foreign inspections have “generally been preannounced,” which makes it hard to judge whether foreign and domestic inspections are truly equivalent. A drugmaker facing a preannounced inspection could theoretically scramble to resolve any problems prior to the FDA’s arrival, for example.
Language barriers pose another problem, with the FDA often forced to rely on the establishment being inspected for translation services, GAO notes. Again, this brings the sanctity of the FDA’s inspection—and the information it's receiving from the relevant company—into question.
Finally, staffing issues have long plagued the FDA overseas. The regulator has reduced vacancies among its general drug inspection workforce, GAO notes, but as of Nov. 2021, eight of 20 positions were vacant in the FDA’s cadre of drug investigators solely assigned to foreign inspections. In addition, five of 15 drug investigator positions were vacant in its offices in China and India, according to GAO.
GAO has several specific recommendations for the FDA regarding a foreign surprise visits pilot program, Mary Denigan-Macauley, Ph.D., director of healthcare at GAO, said over email. For one, the pilot programs should establish measurable objectives and assessment methodology to inform decisions about “whether, how, and when to integrate pilot activities into overall efforts.”
Further, a good pilot program should have a data analysis plan to track results, Denigan-Macauley said. Finally, pilot programs should facilitate two-way stakeholder communications and input at all stages.
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As the FDA’s inspection backlog widens, the agency can't blame the problem on COVID-19 alone. While the pandemic postponed nearly all foreign inspections for most of 2020, the number of foreign inspections conducted by the FDA had “generally been declining” since 2016, thanks in large part to fewer investigators, GAO says.
The FDA did begin to increase the number of its foreign drug inspections in 2019, but the pandemic quickly disrupted that momentum. Between March and Oct. 1, 2020, the FDA conducted just three foreign inspections, according to GAO. From October 2020 to April 2021, the FDA conducted 18 high-priority foreign inspections, mainly in China, GAO added.
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As for pharma's perspective, Andrew Powaleny, senior director of public affairs at the Pharmaceutical Research and Manufacturers of America, said over email that the "biopharmaceutical industry is committed to ensuring facilities producing medicines meet the highest quality standards."
"Looking ahead, the Prescription Drug User Fee Act (PDUFA VII) and Biosimilar User Fee Act (BsUFA III) reauthorizations include commitments advancing U.S. Food and Drug Administration (FDA) workforce hiring and COVID-19 lessons learned around the ongoing use of alternative tools for assessing manufacturing facilities," he continued.
Meanwhile, the FDA on Monday said it was resuming domestic inspections after an omicron-prompted pause in late December.
“In addition to the resumption of planning and conducting domestic surveillance inspections on Feb. 7, the FDA continues to conduct both foreign and domestic mission-critical inspections, as well as provide effective oversight of foods, drugs, medical products and tobacco leveraging a variety of tools, including remote assessments,” the agency said in a statement Monday.
The FDA added it would move forward with previously planned foreign inspections that have country clearance and fall within certain Centers for Disease Control Prevention COVID-19 travel recommendations. The FDA said it was planning more foreign inspections starting in April.
Editor's note: This story has been updated with comments from PhRMA.