In the midst of a war against opioid abuse, FDA Commissioner Scott Gottlieb, M.D., has publicly chastised one of the agency’s key vendors for providing inaccurate sales data on opioids, including fentanyl.
He took to Twitter to call out IQVIA, whose data services are used widely in the industry and by the DEA and other federal agencies to track trends, like opioid sales. The agency said the errors resulted in over-reporting of fentanyl sales by 20% for the last five years. The agency outlined its issues in a release.
The @IQVIA_global errors raise concerns about systemic issues w/their data & quality control procedures. I’ve called on IQVIA to retain an independent 3rd party auditor to conduct a complete review of data quality & QC procedures for data used by FDA https://t.co/sLFCIyddMV (272)
— Scott Gottlieb, M.D. (@SGottliebFDA) May 16, 2018
The company quickly responded. “We stand behind our data methodologies. We value our long-standing relationship with the FDA,” it said in a statement. “We take the FDA’s concerns seriously and will continue working with the FDA to resolve these concerns to its satisfaction.”
The company said that even before the FDA contacted it, the company had discovered an error in its kilogram conversion measurement that led it to overreport sales of “transdermal patches in the opioid market.” It said it had already contacted clients about the issue.
“This measurement conversion issue does not impact our widely used US and global dollar and unit information in NSP or information in any other IQVIA market research services, methodologies or offerings,” the statement said.
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While the FDA acknowledged the data in question was only “narrowly” used by the DEA to determine how much of the controlled substance should be produced in a year, the FDA said a deep dive into other IQVIA data found similar mistakes for sales of other opioids, including oxymorphone and hydrocodone.
“Data integrity and validity are critical to the work FDA does on behalf of the American public,” the FDA said. “When we discover irregularities or inconsistencies in the data we use, we take such deficiencies very seriously.
“(W)e are sharing this information publicly because these data have been used in forecasts that have the potential to impact ongoing work to fight the opioid epidemic,” it said.