From 2016 to 2018, the FDA’s overseas drug facility inspections decreased by about 10%, in part because the agency has struggled to hire new inspectors, according to an analysis from the Government Accountability Office. The findings underscore long-standing concerns about the FDA’s ability to ensure safety and quality of the global supply chain.
Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research, addressed these challenges in testimony before the House Committee on Energy and Commerce. While there are just 12 inspectors currently based overseas, she explained that the agency is looking to hire 50 more people. Ninety percent of the FDA’s foreign inspections are completed by investigators based in the U.S.
“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,” Dr. Woodcock noted. In addition, the FDA provides up to 12 weeks’ notice before inspecting international drug manufacturing facilities, since the practice of conducting unannounced inspections overseas was discontinued in 2015. This is in part to avoid investigators traveling from the U.S. at times when the foreign sites may not be open.
She also pointed to the need for greater standardization of inspectors’ work and documentation. “We’re changing to a more modern, standardized process, which we’ve been able to complete for sterile products,” Dr. Woodcock said.
When asked if the U.S. drug supply is safe, given U.S. reliance on imported pharmaceuticals and ingredients, Dr. Woodcock stated that, while the FDA has good safety systems in place and stands behind the quality of generic drugs, problems are occurring in the area of compounded drugs.