The Food and Drug Administration says it's found mistakes in opioid sales data provided by industry researcher Iqvia that led to an overestimation of the amount of prescription fentanyl being used in the U.S.
The FDA used that data to make recommendations for quotas to the Drug Enforcement Administration, the agency said Wednesday. In addition, the FDA said it found data quality issues with information about the prescription opioids oxymorphone and hydrocodone.
"These additional errors raise serious concerns about systemic issues with IQVIA's data and quality control procedures," the FDA said in a statement on its website, and Commissioner Scott Gottlieb called for the company to hire a third-party auditor to review its quality control.
The discrepancies stem from an error in Iqvia's methods relating to weight-based conversion factors, the FDA said, noting it's "sharing the information publicly as these data have been used in forecasts that have the potential to impact ongoing work to fight the opioid epidemic."
"The FDA uses these data in work to assist the DEA in determining the medical and research needs for Schedule I and II controlled substances in the U.S. for the upcoming year," the FDA said. "These inaccuracies in the IQ data have no known implications for the safety and efficacy or the labeling of FDA-approved fentanyl products."
The FDA said the DEA indicated the Iqvia data is only one of a number of factors that go into its considerations.
Beyond federal applications, Iqvia data are used widely by Wall Street in tracking pharmaceutical sales and prescriptions.
In a statement, the company said it had already identified the error, and notified clients in April. The company said the methodology issue doesn't affect its other market research services.
"We stand behind our data methodologies," Iqvia said. "We value our long-standing relationship with the FDA. We take the FDA's concerns seriously and will continue working with the FDA to resolve these concerns to its satisfaction."
Iqvia's stock was down about 4.6 percent Wednesday before being halted in afternoon trading. When trading resumed later, the shares recouped some losses and closed the day down about 3 percent.