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FDA reports quality problems for data provided by the firm IQVIA that were used to inform estimates for some controlled substances

[5/16/2018] U.S. Food & Drug Administration (FDA) scientists recently discovered an inaccuracy in certain data provided to the agency by the IQVIA National Sales Perspectives database, including data on certain opioid drug products.

IQVIA is a data vendor contracted by FDA that collects data to measure the volume of pharmaceuticals sold by manufacturers and wholesalers to pharmacies, hospitals and other settings. As part of the FDA’s work to better understand the scope of prescription opioid use, evaluate trends and forecast future medical need, FDA regularly utilizes multiple IQVIA data streams. IQVIA also provides data to other federal agencies including the Drug Enforcement Administration (DEA), and other agencies within the U.S. Department of Health and Human Services (HHS).

Data integrity and validity are critical to the work FDA does on behalf of the American public. When we discover irregularities or inconsistencies in the data we use, we take such deficiencies very seriously.

While conducting analyses to estimate the amount of prescription opioids sold in the U.S., FDA found a discrepancy in the IQVIA data that showed a more than 20 percent drop in the reported amount, expressed in kilograms, of fentanyl sold for a minimum of the past five years compared to what IQVIA’s database had previously reported. FDA immediately began an investigation into the cause of this discrepancy and its potential implications. Based on this investigation and discussions with IQVIA, it is our understanding that past data were overestimated by IQVIA because of an error in IQVIA’s methods, which we believe resulted from IQVIA utilizing the wrong weight-based conversion factors to determine the amount of fentanyl in a given unit (such as a single fentanyl patch) for a subset of prescription fentanyl products. This error caused IQVIA to overestimate the total amount of fentanyl distributed into the marketplace when that estimated volume was expressed in kilograms. IQVIA has informed FDA that it is conducting a review of these data to ensure that they are now using the correct conversion factors for fentanyl products and that the new lower estimates are accurate. The FDA has asked IQVIA to notify customers who buy access to these data, including impacted federal agencies, of this error.

While data on sales volume expressed in kilograms are used only narrowly by the FDA, largely in determining the quota recommendations that we make to the DEA, we 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. The FDA uses these data to assist the DEA in determining the medical and research needs for Schedule I and II controlled substances in the U.S. for the upcoming year. These inaccuracies in the IQVIA data have no known implications for the safety and efficacy or the labeling of FDA-approved fentanyl products, and DEA has indicated that the IQVIA data is one of numerous factors it considers when determining the medical and research needs for Schedule I and II controlled substances.

Since the FDA identified these issues, our scientists have been looking methodically at the IQVIA data for similar errors relating to other opioid and non-opioid controlled substances. Our effort is to assess whether the errors were more systematic and widespread, to determine the potential impact of such errors on FDA’s work, and to provide recommendations for addressing this issue within the agency. We also reached out to federal partners, including the DEA.

As a result of this work, we identified additional data quality issues related to several other controlled substances with similar weight-based conversion factors, including oxymorphone and hydrocodone. These additional errors raise serious concerns about systemic issues with IQVIA’s data and quality control procedures.

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. To address these challenges and concerns, FDA Commissioner Scott Gottlieb M.D., has called upon IQVIA to immediately retain a qualified independent, third party auditor to conduct a complete review of the data quality and quality control procedures of the controlled substance data utilized by the FDA. Commissioner Gottlieb also has requested that IQVIA hire a third party to conduct an independent audit of the data quality and quality control of all IQVIA products that FDA utilizes, as well as provide more transparency on the methods IQVIA uses to generate its data. The agency will be working with other federal partners on these issues and briefing members of Congress on IQVIA’s data quality issues and their potential public health implications. We will provide updates to the public and our public health partners as appropriate.

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