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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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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Elcin Barker Ergun, Menarini Group CEO

Amid Roche and Sanofi's oral SERD set­backs, Menar­i­ni gets speedy re­view at FDA

Menarini and Radius Health are getting a speedy review at the FDA for their oral SERD breast cancer drug months after the field opened up with competitors failing and fleeing.

It was a one-two-three punch in March, April and May as Sanofi flunked its first big test for its oral selective estrogen receptor degrader (SERD), Roche also flamed out in a Phase II and G1 Therapeutics ended its program after scoping out the data and potential partners.

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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

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.