Stephen Hahn (AP Images)

New Hahn-era texts show the ex­tent of the Trump White House­'s in­volve­ment in vac­cine EUA process

In the lead-up to the FDA’s is­suance of its first Covid-19 vac­cine EUA to Pfiz­er in Dec. 2020, there was a lot of po­lit­i­cal grum­bling and le­git­i­mate con­cern that the White House might try to speed up the au­tho­riza­tion process to help for­mer Pres­i­dent Don­ald Trump’s re­elec­tion cam­paign.

On the flip side, how­ev­er, there was con­cern of the op­po­site, that the vac­cine’s EUA might be un­nec­es­sar­i­ly de­layed, lead­ing to more deaths so as to avoid any mis­con­cep­tion that the de­ci­sion was po­lit­i­cal­ly mo­ti­vat­ed.

At the time, just pri­or to the first EUA, for­mer Pres­i­dent Trump and his deputies were re­port­ed to be pri­vate­ly crit­i­ciz­ing FDA of­fi­cials for not mov­ing faster.

One se­nior of­fi­cial even told Politi­co on Dec. 2, 2020: “It’s crazy to imag­ine the Eu­ro­pean Union or U.K. may ap­prove a vac­cine de­vel­oped in the Unit­ed States be­fore us though, right?”

And thanks to re­cent­ly re­leased text mes­sages from FDA’s Free­dom of In­for­ma­tion Of­fice, ex­changes be­tween FDA and White House of­fi­cials fur­ther con­firmed this spat over be­ing first.

Fox News re­porter John Roberts texted for­mer FDA com­mis­sion­er Steven Hahn on Dec. 1, 2020 — 10 days be­fore the Pfiz­er vac­cine EUA was is­sued — about the White House tak­ing the FDA “to the wood­shed” over its re­view pace, and ask­ing Hahn if he want­ed to clar­i­fy. Hahn then took the dis­parag­ing com­ment to for­mer White House chief of staff Mark Mead­ows, seek­ing clar­i­fi­ca­tion.

The fol­low­ing morn­ing, Hahn texted Mead­ows at 5:13 AM to in­form him that the UK was about to sign off on Pfiz­er’s Covid-19 vac­cine — which would make the UK’s de­ci­sion faster than the US.

The UK’s MHRA signed off on the Pfiz­er vac­cine lat­er that morn­ing, spurring a flur­ry of texts from Mead­ows to Hahn. Mead­ows al­so sum­moned Hahn and CBER Di­rec­tor Pe­ter Marks to Mead­ows’ of­fice, al­though the FDA’s FOIA of­fice has redact­ed the bulk of the ex­change.

The next six mes­sages of the text ex­change are al­most en­tire­ly redact­ed, and then the night be­fore the EUA is to be is­sued for Pfiz­er’s vac­cine, Mead­ows asks Hahn to call him, which Hahn re­sponds to say that he has, and then sends him this text:

Giv­en the fact that more than 65,000 peo­ple died in Dec. 2020 from Covid-19, and the sen­si­tive na­ture of get­ting the Pfiz­er Covid-19 vac­cine out as rapid­ly as pos­si­ble, as well as the po­lit­i­cal ram­i­fi­ca­tions, it’s not sur­pris­ing that the White House was this in­volved in want­i­ng to be in­formed on the EUA time­line.

But these text mes­sages al­so show some of the ways in which the White House kept the FDA com­mis­sion­er on a short leash and pushed the FDA to speed its re­view process, even as the agency was work­ing at a speed nev­er be­fore seen for any med­ical prod­uct in the agency’s his­to­ry, par­tic­u­lar­ly as it would be ad­min­is­tered to hun­dreds of mil­lions of peo­ple.

As with Pfiz­er’s EUA, Hahn al­so in­formed Mead­ows the night be­fore the agency is­sued its EUA for Mod­er­na’s Covid-19 vac­cine.

The FDA’s FOIA of­fice pre­vi­ous­ly re­leased text mes­sages from Hahn’s dis­cus­sions around for­mer Pres­i­dent Trump’s Covid-19 di­ag­no­sis, as well as ear­li­er com­mu­ni­ca­tions around what types of drugs might work against Covid.

Of­fi­cials from with­in the White House al­so were for­ward­ing po­ten­tial, but ul­ti­mate­ly in­ef­fec­tive Covid-19 treat­ment in­for­ma­tion to Hahn.

Top Trump ad­vi­sor Hope Hicks for­ward­ed an email on a treat­ment called “Cell Ar­mour” to Katie Miller, for­mer com­mu­ni­ca­tions di­rec­tor for Vice Pres­i­dent Mike Pence, who then for­ward­ed it on to Hahn, who said he would look in­to it.

Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; 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.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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In­dus­try groups, CVS pick apart FDA's pro­posed path­way for gener­ics to carve out OTC in­di­ca­tions

Pharma industry groups like the Association for Accessible Medicines (AAM) and PhRMA are raising pointed questions about an FDA plan to create a new pathway for marketing prescription drugs with an additional condition for nonprescription use (ACNU), which would require more safeguards than the current OTC pathway but essentially carve out new OTC uses for some generic drugs.

Chief among the concerns were: Insurance companies dropping coverage for the Rx version, new ACNU patents to block competition, and industry essentially governing the pathway.

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Robert Califf, FDA commissioner (Jose Luis Magana/AP Images)

Fourth ac­cel­er­at­ed ap­proval in Duchenne? Sarep­ta gets pri­or­i­ty re­view for gene ther­a­py amid FDA scruti­ny

Sarepta is once again on the accelerated approval path for a Duchenne drug, picking up a priority review Monday morning.

The FDA granted the accelerated review to SRP-9001, Sarepta announced Monday, which would become the biotech’s fourth Duchenne drug if approved. Much like SRP-9001 will do, each of the previous three therapies went through the accelerated approval pathway. But unlike the others, SRP-9001 is a gene therapy.

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Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

Sanofi's new headquarters, La Maison Sanofi, in Paris (Credit: Luc Boegly)

Sanofi wel­comes 500 staffers to new Paris HQ af­ter €30M ren­o­va­tion

When Paul Hudson took the helm at Sanofi back in 2019, he promised to reinvent the pharma giant — including its Paris headquarters. This week, the company set up shop in new “state-of-the-art” digs.

La Maison Sanofi, as the new HQ is called, is officially open for business, Hudson announced on Monday. The 9,000-square-meter (just under 97,000-square-foot) space accommodates 500 employees across the company’s government and global support functions teams, including finance, HR, legal and corporate affairs — and it was built with environmental sustainability and hybrid work in mind.

Sta­da to place $50M+ in­vest­ment in a new fa­cil­i­ty in Ro­ma­nia

While Romania may conjure up images of vast mountain ranges and tales of medieval kings, one generic manufacturer has broken ground on a new facility there.

German pharma company Stada said Monday that it has placed a €50 million ($51.9 million) investment into a 100,000 square-meter (1.08 million square-foot) site in Turda, Romania, a city in the Southeast of the country. According to a Stada spokesperson in an email to Endpoints News, the company has developed only 281,500 square feet of the site so far.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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