Pfizer and other biopharmas to FDA: Don’t include CMOs in new reporting requirements on drug volume

As the FDA is look­ing to re­duce drug short­ages fur­ther by col­lect­ing more da­ta on the vol­ume of drugs and APIs man­u­fac­tured world­wide, com­pa­nies like Pfiz­er, Ther­mo Fish­er, Vi­a­tris and in­dus­try groups are push­ing back on new guid­ance that seeks to es­tab­lish how that da­ta should be col­lect­ed and sub­mit­ted to the agency.

The tech­ni­cal con­for­mance guide, re­leased last Oc­to­ber, spells out the re­quire­ments un­der Sec­tion 3112(e) of the CARES Act, which was signed in­to law in March 2020 and added a new sec­tion to the FD&C Act.

Un­der this new sec­tion, 510(j)(3), each per­son who reg­is­ters a drug (in­clud­ing repack­ers, re­la­bel­ers and any­one that man­u­fac­tures prod­uct) must re­port to FDA an­nu­al­ly the amount of each list­ed drug that was man­u­fac­tured, pre­pared, prop­a­gat­ed, com­pound­ed, or processed by such per­son for com­mer­cial dis­tri­b­u­tion.

But in com­ments re­leased this week, Pfiz­er is rais­ing con­cerns with FDA that the guid­ance is­sued may cre­ate prob­lems for com­pa­nies that have con­fi­den­tial­i­ty agree­ments with their con­tract man­u­fac­tur­ers.

‘Pro­vid­ing re­ports as re­quired un­der sec­tion 510(j)(3) could be con­sid­ered a breach of these agree­ments and may be im­pact­ful to the CMO busi­ness,’ Pfiz­er wrote.

The com­pa­ny says that it be­lieves that re­port­ing re­spon­si­bil­i­ties should be that of the ‘La­bel­er’ and not the ‘Reg­is­trant’ or the man­u­fac­tur­ing site.

‘We ask that FDA clar­i­fies whether the in­for­ma­tion should be pro­vid­ed by the La­bel­er or each of the Man­u­fac­tur­ing sites,’ the com­pa­ny’s com­ment says.

Sim­i­lar­ly, in­dus­try group BIO sug­gests that the own­er of the NDA or BLA should be the one ac­count­able for the re­port­ing of da­ta re­gard­less of whether the da­ta con­cerns an es­tab­lish­ment they own or not.

‘This seems like it would en­able the FDA to have a con­sol­i­dat­ed view of quan­ti­ty of re­leased drug as well as the quan­ti­ty of dis­trib­uted drug and elim­i­nate the gap of hav­ing the ‘Mar­ket Un­known’. Al­so, BIO be­lieves that BLA/NDA own­ers want the ac­count­abil­i­ty and re­spon­si­bil­i­ty of re­port­ing our prod­uct vol­umes, and it seems odd that BLA own­ers would be­come an ‘au­tho­rized agent’ of an es­tab­lish­ment (like­ly a CMO) rep­re­sent­ed by a ‘reg­is­trant’ that is man­u­fac­tur­ing the prod­uct on their be­half,’ BIO se­nior di­rec­tor Kather­ine Donigan wrote.

Vi­a­tris (formed via the com­bo of My­lan and Pfiz­er’s Up­john) al­so rais­es con­cerns ‘that sev­er­al as­pects of the pro­posed plan are un­du­ly bur­den­some, both for in­dus­try and FDA, and un­nec­es­sary to achieve the pur­pos­es of the new pro­vi­sion.’

The gener­ic pow­er­house points out that with over 275,000 fin­ished and un­fin­ished drug pack­age na­tion­al drug codes, ac­cord­ing to FDA’s NDC di­rec­to­ry, the agency is ask­ing in­dus­try to com­pile, for­mat, and sub­mit over 3.3 mil­lion da­ta points in a short amount of time — less than four months af­ter is­su­ing this guide.

‘Ac­cord­ing­ly, Vi­a­tris re­quests that FDA ex­tend the sub­mis­sion dead­lines for CY 2020 and 2021 in­for­ma­tion un­til at least six and nine months, re­spec­tive­ly, af­ter the Agency is­sues a fi­nal guid­ance to al­low for in­dus­try to pro­vide the req­ui­site in­for­ma­tion in a man­ner con­sis­tent with the fi­nal guid­ance,’ the com­pa­ny said.

Ther­mo Fish­er al­so sought to ex­tend the im­ple­men­ta­tion pe­ri­od, not­ing that ‘an im­pact as­sess­ment on the re­source re­quire­ments rel­a­tive to the val­ue of the da­ta re­port­ed should be un­der­tak­en with stake­hold­ers.’

Sim­i­lar­ly, in­dus­try lob­by­ing group PhRMA ‘en­cour­ages FDA to take a phased ap­proach to the im­ple­men­ta­tion of these re­port­ing re­quire­ments, to de­scribe how the Agency in­tends to use the re­port­ed da­ta to mit­i­gate against drug short­ages, and to fo­cus the Agency’s lim­it­ed re­sources on the op­ti­miza­tion of ex­ist­ing qual­i­ty over­sight tools and ini­tia­tives that will have the great­est im­pact in en­abling FDA and man­u­fac­tur­ers to pre­vent and mit­i­gate drug short­ages.’

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Chris Perkin, Altasciences via Youtube

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