May 16, 2018 / 4:31 PM / 8 days ago

BRIEF-FDA Reports Quality Problems For Data Provided By IQVIA That Were Used To Inform Estimates For Some Controlled Substances

May 16 (Reuters) -

* FDA REPORTS QUALITY PROBLEMS FOR DATA PROVIDED BY THE FIRM IQVIA THAT WERE USED TO INFORM ESTIMATES FOR SOME CONTROLLED SUBSTANCES

* FDA-FOUND DISCREPANCY IN IQVIA DATA THAT SHOWED MORE THAN 20 PERCENT DROP IN REPORTED AMOUNT(KG)OF FENTANYL SOLD FOR A MINIMUM OF PAST FIVE YEARS COMPARED TO PREVIOUSLY REPORTED FIGURE

* FDA SAYS BASED ON ITS INVESTIGATION, IT FOUND THAT PAST DATA WERE OVERESTIMATED BY IQVIA BECAUSE OF AN ERROR IN IQVIA’S METHODS

* FDA-CALLED UPON IQVIA TO IMMEDIATELY RETAIN THIRD PARTY AUDITOR TO CONDUCT REVIEW OF DATA QUALITY, QUALITY CONTROL PROCEDURES OF CONTROLLED SUBSTANCE DATA UTILIZED BY FDA

* FDA-WILL WORK WITH OTHER FEDERAL PARTNERS ON IQVIA’S ISSUES AND BRIEF MEMBERS OF CONGRESS ON IQVIA’S DATA QUALITY ISSUES, POTENTIAL PUBLIC HEALTH IMPLICATIONS

* FDA-WANTS TO ASSESS WHETHER ERRORS WERE MORE SYSTEMATIC AND WIDESPREAD, WANTS TO DETERMINE THE POTENTIAL IMPACT OF SUCH ERRORS ON FDA’S WORK

* FDA - ADDITIONAL DATA QUALITY ERRORS RAISE SERIOUS CONCERNS ABOUT SYSTEMIC ISSUES WITH IQVIA’S DATA AND QUALITY CONTROL PROCEDURES Source text: bit.ly/2ImqOK1 Further company coverage:

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