U.S. health inspectors are still struggling to address a massive backlog of pharmaceutical plants that went uninspected during disruptions caused by COVID-19.
WASHINGTON — Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections in the U.S. and across the world, The Associated Press has found.
“This kind of behavior has been pointed out to the FDA time and time again by people like me for the last 10 years,” said Dinesh Thakur, a former pharmaceutical industry executive who became a whistleblower for the U.S. government. In 2013, his work led to a $500 million settlement with Indian drugmaker Ranbaxy for falsifying generic drug data.“If you do not prosecute people who do this kind of wrongdoing, it gives the implicit signal that the FDA will give companies a pass,” Thakur said.
Coronavirus Pandemic Energy And Commerce Committee FDA FDA Associate Commissioner Michael Rogers FDA Commissioner Robert Califf Food And Drug Administration Data House Of Representatives Indian Drugmaker Ranbaxy Stanford University’S Dr. Kevin Schulman
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