House Energy & Commerce committee chair Frank Pallone (D-NJ) (Kevin Dietsch/Pool via AP Images)

Com­plete­ly clean FDA-in­dus­try user fee deal at­tached to a must-pass gov­ern­ment spend­ing bill

With four days left in the fis­cal year, FDA-re­lat­ed pol­i­cy rid­ers ap­proved in both House and Sen­ate com­mit­tees, at least for now, ap­pear dead, ac­cord­ing to the text of a short-term gov­ern­ment spend­ing bill un­veiled late last night to keep fed­er­al agen­cies open un­til Dec. 16.

But the ab­sence of rid­ers (both sides pre­vi­ous­ly an­nounced a “prac­ti­cal­ly clean” deal last week) doesn’t mean De­moc­rats are done fight­ing to add these ac­cel­er­at­ed ap­provals and oth­er reg­u­la­to­ry re­forms for cos­met­ics, nu­tri­tion­al prod­ucts and di­ag­nos­tic tests.

As part of the agree­ment for a clean CR and user fee deal, De­moc­rats are look­ing to on­ly au­tho­rize cer­tain mea­sures that are tan­gen­tial to the ac­tu­al in­dus­try-FDA agree­ments un­til Dec. 16, which in­cludes all of Ti­tle V in the bill text.

Those par­tial reau­tho­riza­tions set up a like­ly bat­tle in mid-De­cem­ber over pro­grams like the Best Phar­ma­ceu­ti­cals for Chil­dren Pro­gram, which al­lows the NIH to fund stud­ies of off-patent drugs in chil­dren, the or­phan drug grants that de­fray the cost of de­vel­op­ing rare dis­ease drugs, and cer­tain re­port­ing re­quire­ments on pend­ing gener­ic drug ap­pli­ca­tions.

“All four cor­ners [ma­jor­i­ty and mi­nor­i­ty lead­ers in House and Sen­ate] com­mit­ted to re­turn­ing to the ne­go­ti­at­ing ta­ble ahead of the De­cem­ber gov­ern­ment fund­ing dead­line to re­vis­it these key pri­or­i­ties,” House En­er­gy & Com­merce com­mit­tee chair Frank Pal­lone (D-NJ) said in a state­ment last night. “I’m go­ing to con­tin­ue push­ing to ad­vance as much of the House-passed leg­is­la­tion as pos­si­ble.”

But out­side of these de­layed items (and it’s still un­clear who’s op­posed to reau­tho­riz­ing some or all of these mea­sures), De­moc­rats en­tire­ly caved to their Re­pub­li­can peers af­ter much dis­cus­sion and vot­ing on sev­er­al dif­fer­ent re­forms, some of which the FDA even seemed al­most ready to en­dorse. The shift came in late Ju­ly, af­ter Sen. Richard Burr, re­tir­ing mi­nor­i­ty leader on the Sen­ate HELP com­mit­tee, took a stand on a com­plete­ly clean user fee bill.

A clo­ture vote in the Sen­ate, which is like­ly the first step in get­ting the con­tin­u­ing res­o­lu­tion to Pres­i­dent Biden’s desk, is ex­pect­ed this evening. It’s still un­clear which Re­pub­li­cans will join sides with De­moc­rats and pass the spend­ing bill, which needs 60 votes to pass, al­though in­sid­ers don’t ex­pect a gov­ern­ment shut­down ahead of the midterm elec­tions.

Burr and Sen­ate HELP com­mit­tee chair Pat­ty Mur­ray (D-WA) said in a state­ment on the deal that

there is more work ahead this Con­gress to de­liv­er the kinds of re­forms fam­i­lies need to see from FDA, from in­dus­try, and from our men­tal health and pan­dem­ic pre­pared­ness ef­forts. As part of our agree­ment, we and our House coun­ter­parts are com­mit­ted to con­tin­u­ing that work, and in­clud­ing strong, bi­par­ti­san leg­is­la­tion in a ro­bust end of year pack­age.

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.

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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Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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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.