FDA Accused of Regulatory Capture

[Some other agencies similarly accused include the SEC (Naked Shorting), Bank regulators (2008 Financial Crisis), the FAA (Boeing 737 Max).]

December 9, 2020 09:57 AM ESTUpdated 11:23 AM R&DRegulatory



Ad­vo­ca­cy group ac­cus­es FDA neu­ro chief Bil­ly Dunn of mis­con­duct in con­tro­ver­sial Bio­gen re­view, de­mands a purge and fed­er­al probe

John Carroll

Editor & Founder


Pub­lic Cit­i­zen has nev­er held back when it comes to crit­i­ciz­ing the FDA. But to­day, they’re tak­ing their typ­i­cal at­tack mode and ratch­et­ing it up to a whole new lev­el.



The con­sumer ad­vo­ca­cy group has sin­gled out Bil­ly Dunn and his crew of neu­ro spe­cial­ists at the FDA for an “in­ap­pro­pri­ate close col­lab­o­ra­tion with Bio­gen” in the way they han­dled their re­view of Bio­gen’s con­tro­ver­sial Alzheimer’s drug ad­u­canum­ab. From their per­spec­tive, the per­for­mance of Dunn’s group is an­oth­er ex­am­ple of “reg­u­la­to­ry cap­ture” in which they were co-opt­ed by a com­pa­ny in the same way the FAA was ac­cused of af­ter back-to-back crash­es last year in­volv­ing Boe­ing’s 737 MAX that killed hun­dreds of peo­ple.



They are ask­ing the Of­fice of the In­spec­tor Gen­er­al to in­ves­ti­gate the re­la­tion­ship be­tween Dunn and Bio­gen ex­ecs. And in a sep­a­rate let­ter, the ad­vo­ca­cy or­ga­ni­za­tion de­mand­ed that FDA com­mis­sion­er Stephen Hahn re­move Dunn from his role as head of the Of­fice of Neu­ro­sciences un­til an OIG probe is com­plete and as­sign their work on neu­ro to oth­er staffers at the agency not taint­ed by that re­la­tion­ship.



The FDA did not im­me­di­ate­ly re­spond to our re­quest for a re­sponse. Bio­gen re­spond­ed with a state­ment de­fend­ing the drug and its work with the FDA, say­ing:



We are com­mit­ted to dri­ving progress for the Alzheimer’s dis­ease com­mu­ni­ty, and we stand by the in­tegri­ty of the re­view process as FDA con­tin­ues its re­view of our fil­ing.



In their let­ter to Hahn, penned by Michael A. Car­ome, Pub­lic Cit­i­zen not­ed that the “un­bri­dled en­thu­si­asm” Dunn of­fered for ad­u­canum­ab was not sup­port­ed by an ob­jec­tive re­view of the da­ta, where the ad­vo­cates found big prob­lems with the drug. They write:



The cir­cum­stances sur­round­ing the FDA’s col­lab­o­ra­tion with Bio­gen be­fore and af­ter the sub­mis­sion of the BLA for ad­u­canum­ab are a black eye for the agency, fur­ther un­der­min­ing pub­lic con­fi­dence in the FDA, and de­mand your im­me­di­ate at­ten­tion.



Dunn al­ready ex­pe­ri­enced a hu­mil­i­at­ing slap-down dur­ing the out­side pan­el re­view of the drug, with a vir­tu­al­ly unan­i­mous vote against ap­proval as sev­er­al clear­ly an­gry pan­elists de­mand­ed to know why Dunn was will­ing to shrug off long es­tab­lished stan­dards and en­thu­si­as­ti­cal­ly back a drug that failed one of 2 piv­otal stud­ies. The FDA has yet to of­fer a fi­nal de­ci­sion, with a PDU­FA com­ing up in March, but a num­ber of an­a­lysts still be­lieve that Dunn can get this drug over the fin­ish line and in­to the mar­ket­place.



These de­mands, though, will keep ad­u­canum­ab un­der a dark cloud at the agency, mak­ing any fa­vor­able de­ci­sion prob­lem­at­ic at best.



The FDA’s neu­ro staffers have faced re­peat­ed crit­i­cism over the past year, and not just be­cause of ad­u­canum­ab. J&J’s ap­proval for their de­pres­sion drug es­ke­t­a­mine has spurred ques­tions over the da­ta, which in­cludes failed stud­ies as well. A fol­low-up ap­proval for Sarep­ta in Duchenne mus­cu­lar dy­s­tro­phy based on a prece­dent-set­ting de­ci­sion us­ing in­con­clu­sive bio­mark­er da­ta has al­so raised ques­tions af­ter a fed­er­al reg­u­la­tor’s ini­tial CRL was set aside.



Whether all that is enough to trig­ger a shake­up at the agency at a time the FDA is de­fend­ing the gold stan­dard ap­proach for the Covid-19 vac­cines has yet to be seen.