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Violations of data rules on the rise

by Glenn Hess, special to C&EN
April 4, 2016 | A version of this story appeared in Volume 94, Issue 14

More pharmaceutical companies than ever before are being warned by FDA because they allegedly falsified, altered, or failed to keep accurate data about how their drugs are made and tested, according to an analysis by the Health Research Institute (HRI). At issue are data integrity violations of FDA’s manufacturing regulations, which are meant to ensure that drugs are safe, effective, and without defects that might harm patients. From 2010 to 2012, just five drugmakers were cited for such violations, says HRI, a part of global consulting and auditing firm PricewaterhouseCoopers. But from 2013 to 2015, two dozen were cited, and nearly all were located outside the U.S. Of the 29 warning letters FDA sent to drug companies for data integrity issues over the last five years, 18 went to facilities based in India and six in China, HRI says. Although nearly 70% of FDA’s inspections were conducted domestically, only one facility in the U.S. was cited for a violation. FDA increased its focus on data integrity after Congress in 2012 gave the agency more money and increased authority to conduct inspections.


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