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 is used widely by Wall Street in tracking pharmaceutical sales and prescriptions.
Iqvia didn’t immediately respond to a request for comment.
Source: Investment Cnbc
Iqvia shares drop 5% after FDA finds errors in its opioid sales data, calls for quality review