FDA faults IQVIA for er­rors in opi­oid sales da­ta, calls for qual­i­ty re­view

The FDA is call­ing up­on IQVIA to re­view its da­ta qual­i­ty and method­olo­gies af­ter find­ing er­rors re­gard­ing sales vol­ume da­ta on cer­tain con­trolled sub­stance, in­clud­ing opi­oids. Cit­ing “se­ri­ous con­cerns about sys­temic is­sues with IQVIA’s da­ta and qual­i­ty con­trol pro­ce­dures,” the agency has re­quest­ed IQVIA run an in­de­pen­dent au­dit.

In a state­ment, IQVIA — the world’s largest clin­i­cal out­sourc­ing firm and a wide­ly used da­ta ven­dor — said it’s been ad­dress­ing the is­sue, which it had al­ready iden­ti­fied pri­or to the no­ti­fi­ca­tion. It al­so says it’s work­ing with the FDA to re­solve con­cerns — some­thing that the FDA ac­knowl­edged in its own re­lease.

The da­ta in ques­tion were meant to bol­ster the FDA’s un­der­stand­ing of the scope of pre­scrip­tion opi­oid use, the agency said, and were used to make rec­om­men­da­tions to the Drug En­force­ment Ad­min­is­tra­tion.

FDA sci­en­tists first no­ticed a dis­crep­an­cy with the re­port­ed amount of fen­tanyl sold, caus­ing IQVIA to over­es­ti­mate the to­tal amount of fen­tanyl dis­trib­uted in the mar­ket when ex­pressed in kilo­grams. Sub­se­quent dis­cus­sions and in­ves­ti­ga­tion re­vealed that the er­ror stems from IQVIA’s use of wrong weight-based con­ver­sion fac­tors. They al­so found prob­lems with da­ta for oxy­mor­phone and hy­drocodone.

“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,” the FDA said be­fore in­tro­duc­ing Com­mis­sion­er Scott Got­tlieb’s di­rec­tions to the com­pa­ny.

Got­tlieb wants IQVIA to hire a third par­ty au­di­tor to as­sess all IQVIA prod­ucts that FDA uti­lizes and “pro­vide more trans­paren­cy on the meth­ods IQVIA us­es to gen­er­ate its da­ta.” Giv­en that IQVIA al­so serves da­ta to the DEA and oth­er HHS agen­cies, the FDA will al­so be work­ing with fed­er­al part­ners and — no­tably — “brief­ing mem­bers of Con­gress on IQVIA’s da­ta qual­i­ty is­sues and their po­ten­tial pub­lic health im­pli­ca­tions.”

The high pro­file lash­ing against one spe­cif­ic ven­dor on a tech­ni­cal is­sue was an un­usu­al move for the FDA, which tends to stick to trends. It does, how­ev­er, come at a time Con­gress is con­sid­er­ing a slate of opi­oid leg­is­la­tions, fu­eled by the in­tense pub­lic at­ten­tion to the opi­oid cri­sis, in which Got­tlieb has been giv­en a big role.

Even though this type of in­for­ma­tion was on­ly used nar­row­ly, the FDA said, it chose to share the in­for­ma­tion pub­licly “be­cause these da­ta have been used in fore­casts that have the po­ten­tial to im­pact on­go­ing work to fight the opi­oid epi­dem­ic.”

“We stand be­hind our da­ta method­olo­gies,” IQVIA stat­ed in its re­sponse. “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.”


Im­age: FDA Com­mis­sion­er Scott Got­tlieb. GET­TY IM­AGES

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Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

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