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.”

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.