FDA Flags Data Inaccuracy, Quality Issues at IQVIA

May 17, 2018

The FDA took vendor IQVIA to task for a discrepancy in data regarding sales of opioid drug products that the agency said could undermine forecasts used in the fight against addiction.

IQVIA collects data to measure the volume of drugs sold by manufacturers and wholesalers to pharmacies and hospitals. The agency found an error in the amount of prescription opioids sold in the U.S., with the data showing a more than 20 percent drop in the reported amount of fentanyl, in kilograms, sold in at least the past five years compared to what IQVIA previously reported.

“While data on sales volume expressed in kilograms are used only narrowly by the FDA … we are sharing this information publicly because these data have been used in forecasts that have the potential to impact ongoing work to fight the opioid epidemic,” the agency said.

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