Sen­a­tors ques­tion how HHS plans to roll out new drug pric­ing re­forms

While CMS drug price ne­go­ti­a­tions won’t ac­tu­al­ly kick off un­til 2026, a group of more than two dozen Re­pub­li­can sen­a­tors is al­ready rais­ing ques­tions about how this new law will be im­ple­ment­ed.

The par­ti­san law (all De­moc­rats in the House and Sen­ate vot­ed for it, and all Re­pub­li­cans vot­ed against it) in­cludes not on­ly Medicare price ne­go­ti­a­tions but manda­to­ry in­fla­tion-re­lat­ed re­bates that will be­gin next year, as well as mil­lion-dol­lar fines for non­com­pli­ance.

In a let­ter sent ear­li­er this week to both HHS Sec­re­tary Xavier Be­cer­ra and CMS ad­min­is­tra­tor Chiq­ui­ta Brooks-La­Sure, the group of 25 Re­pub­li­can sen­a­tors ex­pressed “con­cerns with the dis­rup­tive and dis­tortive ad­min­is­tra­tive un­der­tak­ing that the im­ple­men­ta­tion of this far-reach­ing fed­er­al ex­pan­sion will in­evitably rep­re­sent.”

They al­so note both the CBO’s point that the ne­go­ti­a­tions could in­crease launch prices for new drugs, and re­duce the num­ber of new drug ap­provals in the com­ing years.

The law’s true im­pact on bio­phar­ma R&D may be dif­fi­cult to track, giv­en the fact that there are usu­al­ly mul­ti­ple rea­sons a drug’s de­vel­op­ment might be dis­con­tin­ued. The CBO has said that over the next 30 years, of the ap­prox­i­mate­ly 1,300 drugs ap­proved, about 15 drugs may be cut from bio­phar­ma com­pa­nies’ col­lec­tive pipelines, in­clud­ing two over the 2023-2032 pe­ri­od, about five over the sub­se­quent decade, and about eight over the third decade.

“Oth­er in­de­pen­dent analy­ses have pro­ject­ed even more cat­a­stroph­ic con­se­quences, from hun­dreds of thou­sands of do­mes­tic job loss­es to hun­dreds of bil­lions in for­gone R&D dol­lars,” the Re­pub­li­cans wrote.

Com­pa­nies like Eli Lil­ly, No­vo Nordisk and As­traZeneca may be dis­pro­por­tion­ate­ly af­fect­ed by the law.

The Re­pub­li­cans, which in­clud­ed Utah’s Mitt Rom­ney, North Car­oli­na’s Thom Tillis, and West Vir­ginia’s Shel­ley Moore Capi­to, al­so note that the law’s im­ple­men­ta­tion doesn’t use the stan­dard no­tice-and-com­ment rule­mak­ing process typ­i­cal­ly re­quired for such “sub­stan­tive reg­u­la­to­ry pol­i­cy­mak­ing.” This “ex­clu­sion of pa­tient voic­es from pol­i­cy­mak­ing pos­es po­ten­tial­ly cat­a­stroph­ic con­se­quences, par­tic­u­lar­ly for in­di­vid­u­als liv­ing with rare dis­eases or with dis­abil­i­ties,” they wrote, re­quest­ing de­tails on how those voic­es will be heard.

The group al­so seeks in­fo on plans to “en­force the leg­is­la­tion’s ban on the use of dis­crim­i­na­to­ry com­par­a­tive ef­fec­tive­ness re­search” and ques­tions on “the lack of a floor for Sec­re­tary-dic­tat­ed prices.”

And the fi­nal ques­tion from the group is on how the ad­min­is­tra­tion plans to mon­i­tor these wide-rang­ing ef­fects of the new pro­gram, on every­thing from pa­tient ac­cess to R&D in­vest­ments, launch prices, new drug ap­provals and do­mes­tic man­u­fac­tur­ing jobs.

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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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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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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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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Rachael Rollins (Charles Krupa/AP Images)

US seeks jail time for co-CEO of New Eng­land com­pound­ing cen­ter af­ter dead­ly 2012 fun­gal out­break

The US attorney for the district of Massachusetts late last week called on the state’s district court to sentence the former co-owner of the now-defunct New England Compounding Center to 18 months of jail time for his role in the center’s quality deviations that led to more than 100 people dead from a fungal meningitis outbreak.

Gregory Conigliaro was convicted of conspiring with more than a dozen others at NECC to deceive the FDA and misrepresent the fact that the center was only dispensing drugs pursuant to patient-specific prescriptions.

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.