The FDA is calling upon IQVIA to review its data quality and methodologies after finding errors regarding sales volume data on certain controlled substance, including opioids. Citing “serious concerns about systemic issues with IQVIA’s data and quality control procedures,” the agency has requested IQVIA run an independent audit.
In a statement, IQVIA — the world’s largest clinical outsourcing firm and a widely used data vendor — said it’s been addressing the issue, which it had already identified prior to the notification. It also says it’s working with the FDA to resolve concerns — something that the FDA acknowledged in its own release.
The data in question were meant to bolster the FDA’s understanding of the scope of prescription opioid use, the agency said, and were used to make recommendations to the Drug Enforcement Administration.
FDA scientists first noticed a discrepancy with the reported amount of fentanyl sold, causing IQVIA to overestimate the total amount of fentanyl distributed in the market when expressed in kilograms. Subsequent discussions and investigation revealed that the error stems from IQVIA’s use of wrong weight-based conversion factors. They also found problems with data for oxymorphone and hydrocodone.
“Having reliable and accurate data is essential to the FDA’s mission to protect and promote public health, and IQVIA is often the sole source provider for certain data,” the FDA said before introducing Commissioner Scott Gottlieb’s directions to the company.
Gottlieb wants IQVIA to hire a third party auditor to assess all IQVIA products that FDA utilizes and “provide more transparency on the methods IQVIA uses to generate its data.” Given that IQVIA also serves data to the DEA and other HHS agencies, the FDA will also be working with federal partners and — notably — “briefing members of Congress on IQVIA’s data quality issues and their potential public health implications.”
The high profile lashing against one specific vendor on a technical issue was an unusual move for the FDA, which tends to stick to trends. It does, however, come at a time Congress is considering a slate of opioid legislations, fueled by the intense public attention to the opioid crisis, in which Gottlieb has been given a big role.
Even though this type of information was only used narrowly, the FDA said, it chose to share the information publicly “because these data have been used in forecasts that have the potential to impact ongoing work to fight the opioid epidemic.”
“We stand behind our data methodologies,” IQVIA stated in its response. “We value our long-standing relationship with the FDA. We take the FDA’s concerns seriously and will continue working with the FDA to resolve these concerns to its satisfaction.”
Image: FDA Commissioner Scott Gottlieb. GETTY IMAGES
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