May 16, 2018 / 5:45 PM / 7 months ago

UPDATE 2-FDA reports inaccuracy in IQVIA data on opioids

(Recasts lead paragraph, adds IQVIA statement, detail from FDA and on stock offering)

May 16 (Reuters) - The U.S. Food & Drug Administration on Wednesday said it found inaccuracies in information on opioid sales provided by healthcare data firm IQVIA Holdings Inc and called on the company to hire an independent auditor to review its data quality.

The regulator said it found additional issues with IQVIA's information about other controlled substances.

The errors "raise serious concerns about systemic issues with IQVIA's data and quality control procedures," the regulator said in a statement.

Shares of IQVIA were down 3.1 percent at $98.90, after falling as much as 10.3 percent earlier in the day.

IQVIA said in a statement that it identified the issue before the FDA and notified clients about it in April. It said the issue did not impact its dollar and unit sales data.

Earlier in the day, the company priced a secondary offering of 10 million shares at $101.85 on behalf of private equity and other investors who own much of the company, including TPG, the Canada Pension Plan Investment Board and Bain Capital. That offering is not scheduled to close until Friday.

The FDA said it found that IQVIA has overestimated the sales of fentanyl in the United States due to a problem in converting the data to kilograms. The regulator uses this information to help it estimate the amount of prescription opioids sold in the United States.

It said IQVIA adjusted some of its data for fentanyl sales in the U.S. down by more than 20 percent, the regulator said.

The FDA said it plans to brief members of Congress on IQVIA's data quality issues and their potential impact on public health.

IQVIA told the FDA that it is conducting a review of its fentanyl data, and that it stands by the new, lower estimates. The regulator has asked the data company to inform its customers of the error.

IQVIA collects data to measure the volume of drugs sold by manufacturers and wholesalers to pharmacies and hospitals.

The FDA uses IQVIA's drug sales data to assess the scope of prescription opioid use and evaluate trends, which it then uses to help make policy recommendations. The Drug Enforcement Administration and other Health and Human Services agencies also use the data.

FDA Commissioner Scott Gottlieb asked the company to have a third-party auditor review the quality control measures on IQVIA drug sales data as well as all other products that the regulator uses. (Reporting by Michael Erman in New York and Mrinalini Krothapalli and Anuron Kumar Mitra in Bangalore ; Editing by Arun Koyyur and Nick Zieminski)

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