FDA Publicly Shames IQVIA

Gottlieb takes IQVIA to task on Twitter for inaccurate opioid sales data

FDA Commissioner Scott Gottlieb, M.D., has publicly reprimanded IQVIA, a global provider of advanced analytics, technology solutions, and contract research services to the life sciences industry, for providing inaccurate sales data on opioids, including fentanyl.

As reported by Eric Palmer in Fierce Pharma, Gottlieb, whose agency is in the midst of a huge campaign against opioid abuse, utilized Twitter, to scold IQVIA, whose data services are used extensively in the industry and by the Drug Enforcement Agency (DEA) and other federal agencies to monitor trends, such as opioid sales. The FDA said that the errors led to over-reporting of fentanyl sales by 20 percent for the last five years.

Gottlieb’s tweet said, “The @IQVIA 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.”

IQVIA quickly responded, “We stand behind our data methodologies. 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.”

According to IQVIA, the company had discovered an error in its kilogram conversion measurement that led it to overreport sales of “transdermal patches in the opioid market” even before the FDA contacted it. IQVIA further claimed that 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 FDA explained.

Although the FDA agreed that the data in question was only “narrowly” utilized by the DEA to determine how much of the controlled substance should be produced in a year, the FDA said a deep look into additional IQVIA data showed similar mistakes for sales of other opioids, including oxymorphone and hydrocodone.

The FDA stated, “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. (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.”

Created by the 2017 merger of IMS Health and Quintiles, IQVIA applies human data science to enable companies to develop new approaches to clinical development and commercialization, speed innovation, and accelerate improvements in healthcare outcomes. Powered by the IQVIA CORE™, IQVIA delivers actionable insights with large-scale analytics, technology, and domain expertise. The company has more than 55,000 employees and conducts operations in more than 100 countries. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors, and scientific advances.