If this were a dispute between statisticians at FDA and elsewhere over, say, sodium bicarbonate consumption, it would probably barely be noticed. But since it involves opioids—and fentanyl, specifically—FDA chose to issue a public statement challenging IQVIA’s recent reporting of opioid consumption in the US. Those consumption figure play into decisions that get made by, among others, the Drug Enforcement Administration on annual allocations of opioid imports and their constituents, as well as other assessments as government and industry deal with the ongoing opioid-abuse crisis.
FDA, like other federal agencies and a large fraction of the pharma industry and other healthcare entities, are customers of IQVIA’s sales-data reports. Recently, “while conducting analyses to estimate the amount of prescription opioids sold in the US, FDA found a discrepancy in the IQVIA data that showed a more than 20% 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,” said FDA in its statement. The error apparently has to do with how the volume of drug in a dosage (such as a transdermal patch) is converted to an overall bulk weight figure for US consumption. FDA further stated that “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.”
The methodology errors also affected other opioid-consumption figures, such as oxymorphone and hydrocodone, which “raise serious concerns about systemic issues with IQVIA’s data and quality control procedures,” stated FDA. For its part, IQVIA says that it had already identified the source of errors and made corrections—and had notified clients in April about the adjustment. And although it said, in a press announcement, “we take the FDA’s concerns seriously and will continue working with the FDA to resolve these concerns to its satisfaction,” it did not say anything about FDA’s request to hire a third-party auditor.
Pharma industry analysts are accustomed to working with the sometimes fudgy IQVIA figures, which are based on estimates within certain trade channels, and which tend to get corrected through retrospective analyses at times. “IQVIA routinely updates its national audits, which may result in changes to previously reported market size and growth rates” is how it qualifies its processes. On the other hand, IQVIA has built a multi-billion-dollar business on tracking these data globally, and in some companies, sales reps’ compensation is based on the data. As much as anything else, the errors point to the complexities of the many channels and operational issues of drug distribution in the US.