Foreign drug inspections decline as FDA hiring struggles continue
The US reliance on imported pharmaceuticals and ingredients is rising as foreign drug facility inspections decreased by about 10% from 2016 to 2018. Part of the reason for the decline: The US Food and Drug Administration (FDA) said it’s still struggling to hire new inspectors.
Testifying before a House subcommittee on Tuesday, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, defended the agency’s approach and discussed some of the vulnerabilities of its foreign inspection program. She said FDA is looking to hire 50 new inspectors, but there are difficulties.
“Even if the Agency succeeds in hiring a new investigator, it can take 1.5 to 2 years of training to bring them to a fully proficient level,” Woodcock said in her written testimony. With just 12 foreign-based drug investigators currently, FDA says 90% of its foreign inspections are conducted by US-based inspectors.
Greg Walden (R-OR) questioned Woodcock and pointed to a new Government Accountability Office (GAO) report that found FDA is not completing enough foreign drug inspections, cannot hire enough inspectors and that it provides up to 12 weeks notice for some overseas inspections. He also noted that FDA previously conducted unannounced foreign drug manufacturing inspections but this initiative was discontinued in 2015.
Woodcock, meanwhile, said more work is needed on the standardization of the inspection program. There is standardization for what inspectors do and how they document it, she said, and “we’re changing to a more modern, standardized process, which we’ve been able to complete for sterile products.”
Mary Denigan-Macauley, director of health care at GAO, also testified on Tuesday that FDA routinely gives foreign drug manufacturers significant advanced notice of overseas inspections, while the agency does not announce many domestic inspections. But she said inspectors face other challenges overseas, with single inspectors sometimes covering multiple facilities across acres of land. Investigators also may have to use a manufacturer’s translators and there can be uncertainty about the accuracy of certain translations.
Domestic and overseas inspections need to be similar, Denigan-Macauley said.
Woodcock noted that foreign companies are notified ahead of some inspections because they usually involve multiple inspectors coming over from the US, and the notification is meant to ensure those facilities will be open.
Woodcock also pointed to plans at FDA to create incentives for manufacturers to invest in product quality. Part of such plans is to develop and implement a rating system for quality management maturity based on objective criteria. “Such a rating system could enable purchasers to compare differences in quality and choose whether to reward more reliable manufacturers financially and with increased market share,” Woodcock said in her written testimony.
On the issue of quality, Rep. David McKinley (R-WV) asked Woodcock if the generic drug supply is safe. And she assured him that FDA stands behind generic drugs and that the agency has good safety systems in place. Compounded drugs, however, is an area where problems are occurring, she added.
RAPS: First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products.