Citing coronavirus (COVID-19) concerns, the U.S. FDA revealed that it will suspend routine inspections of food, drugs, and medical devices overseas through April. This move—which mostly affects India, a key generics manufacturer—follows the agency’s previous decision to halt inspections from China.
“At a time when there are shortages of medicines — critical medicines — there’s a lot of untoward activity that can take place, like counterfeits and poor quality products,” said Rosemary Gibson, an expert on China’s drug supply who is a senior adviser at the Hastings Center, a nonpartisan bioethics research institute. “The bottom line is, who is going to be checking?”
The FDA has a staff of about 200 investigators who conduct overseas drug inspections, according to testimony before a House committee in December by Janet Woodcock, the director of the agency’s Center for Drug Evaluation and Research. Most of those inspectors are based in the United States and travel around the world to conduct from three to six inspections per year. Of those, about 12 are based in foreign offices overseas, including in China.