FDA finds errors in Iqvia opioid sales data, calls for quality review
The Meals and Drug Administration says it is discovered errors in opioid gross sales knowledge supplied by trade researcher Iqvia that led to an overestimation of the quantity of prescription fentanyl getting used within the U.S.
The FDA used that knowledge to make suggestions for quotas to the Drug Enforcement Administration, the company mentioned Wednesday. As well as, the FDA mentioned it discovered knowledge high quality points with details about the prescription opioids oxymorphone and hydrocodone.
“These further errors increase critical issues about systemic points with IQVIA’s knowledge and high quality management procedures,” the FDA mentioned in an announcement on its web site, and Commissioner Scott Gottlieb known as for the corporate to rent a third-party auditor to overview its high quality management.
The discrepancies stem from an error in Iqvia’s strategies referring to weight-based conversion elements, the FDA mentioned, noting it is “sharing the knowledge publicly as these knowledge have been utilized in forecasts which have the potential to impression ongoing work to struggle the opioid epidemic.”
“The FDA makes use of these knowledge 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 knowledge haven’t any identified implications for the security and efficacy or the labeling of FDA-approved fentanyl merchandise.”
The FDA mentioned the DEA indicated the Iqvia knowledge is just one of a lot of elements that go into its issues.
Past federal purposes, Iqvia knowledge are used extensively by Wall Road in monitoring pharmaceutical gross sales and prescriptions.
Iqvia’s inventory was down about four.6 p.c Wednesday earlier than being halted in afternoon buying and selling. The corporate 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