The Meals and Drug Administration says it is discovered errors in opioid gross sales information supplied by business researcher Iqvia that led to an overestimation of the quantity of prescription fentanyl getting used within the U.S.
The FDA used that information to make suggestions for quotas to the Drug Enforcement Administration, the company mentioned Wednesday. As well as, the FDA mentioned it discovered information high quality points with details about the prescription opioids oxymorphone and hydrocodone.
“These extra errors elevate severe issues about systemic points with IQVIA’s information and high quality management procedures,” the FDA mentioned in a press release on its web site, and Commissioner Scott Gottlieb known as for the corporate to rent a third-party auditor to evaluate its high quality management.
The discrepancies stem from an error in Iqvia’s strategies referring to weight-based conversion components, the FDA mentioned, noting it is “sharing the data publicly as these information have been utilized in forecasts which have the potential to impression ongoing work to struggle the opioid epidemic.”
“The FDA makes use of these information in work to help the DEA in figuring out the medical and analysis wants for Schedule I and II managed substances within the U.S. for the upcoming yr,” the FDA mentioned. “These inaccuracies within the IQ information don’t have any identified implications for the protection and efficacy or the labeling of FDA-approved fentanyl merchandise.”
The FDA mentioned the DEA indicated the Iqvia information is just one of numerous components that go into its issues.
Past federal functions, Iqvia information are used broadly by Wall Avenue in monitoring pharmaceutical gross sales and prescriptions.
Iqvia did not instantly reply to a request for remark.
Supply hyperlink – https://www.cnbc.com/2018/05/16/fda-finds-errors-in-iqvia-opioid-sales-data-calls-for-quality-review.html