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The report examines the increased number of companies cited by regulators for data integrity issues.
According to a report released by PwC in March 2016, there have been an increased number of pharmaceutical companies warned by regulators for “falsifying, altering, or failing to protect essential quality data about how their drugs are made and tested.”
PwC’s Health Research Institute (HRI) conducted a review in February 2016 of FDA’s quality regulations and inspection. According to PwC, “the top deficiency observed during FDA inspections between 2011 and 2014 was failing to follow written quality procedures.” HRI says another challenge was handling the trustworthiness of collected data. HRI says the number of companies cited by FDA for data integrity violations has grown since 2010. The number of companies receiving warnings from the agency for data integrity issues jumped from five in 2010 to 2012, to 24 from 2013 to 2015.
HRI notes the three most common issues cited by FDA between 2013–2015 were lack of controls to prevent alterations of data by staff, a failure to maintain records of accurate data, and delayed reporting of data. HRI says violations were disproportionately found in countries outside of the US. Of the 29 data integrity violation letters sent by FDA between 2010 and 2015, 18 were sent to Indian companies and 6 to Chinese companies.
HRI says “warnings may be increasing in the wake of new authority and financial resources given to the FDA by Congress in 2012.” FDA has been increasing foreign drug quality inspections; the rate of inspections has increased from 20.6% in 2010 to 39.2% in 2015, according to PwC estimates.
HRI cites three industry implications of the increased focus on data integrity: