An investigation by FDA scientists revealed numerous data inaccuracies in reports that data vendor IQVIA provided to the agency, including data on opioid drug products, the agency announced May 16.
IQVIA is contracted by the FDA to gather data measuring the volume of pharmaceuticals manufacturers and wholesalers sell to pharmacies and hospitals. The FDA frequently uses multiple data streams from IQVIA.
"Data integrity and validity are critical to the work FDA does on behalf of the American public," the agency said. "When we discover irregularities or inconsistencies in the data we use, we take such deficiencies very seriously."
When analyzing data to estimate the amount of prescription opioids sold in the U.S., the FDA found a discrepancy in the IQVIA data that showed a more than 20 percent decrease in the reported amount of fentanyl sold for a minimum of the last five years, compared with what IQVIA's database previously reported.
As a result of this discrepancy, the FDA launched an investigation and found IQVIA overestimated past data due to an error in its methods.
"We believe [the error] resulted from IQVIA utilizing the wrong weight-based conversion factors to determine the amount of fentanyl in a given unit [such as a single fentanyl patch] for a subset of prescription fentanyl products," the agency said.
The error caused IQVIA to overestimate the total amount of fentanyl put into the marketplace when the estimated volume was expressed in kilograms.
IQVIA told the FDA it is conducting a review of the data to ensure it now is using the correct conversion factors for fentanyl products and that the new lower estimates are accurate, the agency said. The FDA requested IQVIA tell customers who buy access to the data about the error.
The FDA also identified data quality problems linked to several other controlled substances, including oxymorphone and hydrocodone.
FDA Commissioner Scott Gottlieb, MD, called upon IQVIA to retain a qualified independent, third-party auditor to launch a review of the data quality and quality control procedures of controlled substances.
The FDA said it is working with other federal partners to address these issues and will provide updates to the public when appropriate.