The Food along with Drug Administration says the item’s found mistakes in opioid sales data provided by industry researcher Iqvia of which led to an overestimation of the amount of prescription fentanyl being used within the U.S.
The FDA used of which data to make recommendations for quotas to the Drug Enforcement Administration, the agency said Wednesday. In addition, the FDA said the item found data quality issues with information about the prescription opioids oxymorphone along with hydrocodone.
“These additional errors raise serious concerns about systemic issues with IQVIA’s data along with quality control procedures,” the FDA said in a statement on its website, along with Commissioner Scott Gottlieb called for the company to hire a third-party auditor to review its quality control.
The discrepancies stem by an error in Iqvia’s methods relating to weight-based conversion factors, the FDA said, noting the item’s “sharing the information publicly as these data have been used in forecasts of which hold 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 along with research needs for Schedule I along with II controlled substances within the U.S. for the upcoming year,” the FDA said. “These inaccuracies within the IQ data have no known implications for the safety along with efficacy or the labeling of FDA-approved fentanyl products.”
The FDA said the DEA indicated the Iqvia data can be only one of several factors of which go into its considerations.
Beyond federal applications, Iqvia data are used widely by Wall Street in tracking pharmaceutical sales along with prescriptions.
In a statement, the company said the item had already identified the error, along with notified clients in April. The company said the methodology issue doesn’t affect its additional 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 along with 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 along with closed the day down about 3 percent.