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

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Months af­ter FDA re­jec­tion, Sanofi touts piv­otal win for rare dis­ease drug su­tim­limab as it preps to re­file

One of the pillar drugs of Sanofi’s $11.6 billion pickup of Bioverativ hit a big setback late last year when the FDA sent its application for approval back. Now, as Sanofi gears up to resubmit the drug for review, the drugmaker is touting pivotal data it hopes will help take it over the finish line.

Sanofi’s sutimlimab nailed all three of its primary endpoints in its Phase III CADENZA study for patients with cold agglutinin disease, a rare disorder that can cause severe anemia, without a recent history of blood transfusion, the French drugmaker said Friday. The topline results will be presented at this weekend’s virtual EHA meeting.

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Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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Bris­tol My­er­s' CAR-T Breyanzi busts out a win in ear­li­er-line lym­phoma, po­ten­tial­ly crack­ing open an ex­pand­ed mar­ket

Despite being third to the field in B cell lymphoma, Bristol Myers Squibb has repeatedly argued its CAR-T Breyanzi could have the juice to overtake its older competitors. Going into earlier lines of therapy may be the golden ticket on that front, and now Breyanzi has a late-stage win to back up that effort.

Bristol Myers’s Breyanzi beat out physicians’-choice salvage therapy followed by high-dose chemo and a stem cell transplant — what the drugmaker called a “gold standard treatment” — in second-line patients with relapsed or refractory large B cell lymphoma, according to topline data from the Phase III TRANSFORM study released Thursday.