President Joe Biden (AP Images)

Ma­jor drug price re­forms head for Biden's sig­na­ture as PhRMA weighs le­gal op­tions

The fact that the new drug price ne­go­ti­a­tions for cer­tain block­buster Medicare drugs — due for a par­ti­san thumbs up in the US House of Rep­re­sen­ta­tives on Fri­day and a sig­na­ture from Pres­i­dent Joe Biden soon af­ter — don’t take ef­fect un­til 2026 means there’ll be plen­ty of time for PhRMA and oth­ers in bio­phar­ma to weigh their le­gal op­tions.

But what PhRMA or any bio­phar­ma com­pa­ny may po­ten­tial­ly sue over will be the key, as le­gal ex­perts point to the com­pli­cat­ed ne­go­ti­a­tions side of the rec­on­cil­i­a­tion bill, which be­gin­ning in 2026 would kick off these price con­ces­sions for 10 of the most ex­pen­sive sin­gle-source drugs in Medicare’s Part D pro­gram, build­ing up to about 60 drugs from both Part D and B by 2030, with prices gen­er­al­ly capped by at least 40%.

Con­sid­er­able at­ten­tion by Con­gress has been paid to small­er com­pa­nies and drugs and bi­o­log­ics with im­pend­ing com­pe­ti­tion. For in­stance, in 2029 and 2030, there would be a max­i­mum fair price floor of 66% of the av­er­age non-FAMP for small biotech com­pa­nies’ bi­o­log­ics (com­pared to 75% for most drugs that have been on the mar­ket for less than 12 years), ac­cord­ing to the law firm Hogan Lovells.

Still, if man­u­fac­tur­ers fail or de­cline to com­ply with the ne­go­ti­a­tion process, they would be sub­ject to a sig­nif­i­cant ex­cise tax (build­ing up from 65% of a drug’s sales to 95%), which is a stick so large that it could po­ten­tial­ly run afoul of the ex­ces­sive fines clause of the Eighth Amend­ment of the Con­sti­tu­tion, le­gal ex­perts said.

“As­sum­ing the ex­cise tax is not au­tho­rized by Con­gress’s tax­ing pow­er alone and is ac­tu­al­ly a means of en­forc­ing a reg­u­la­to­ry drug pric­ing statu­to­ry scheme, it could be viewed as a puni­tive mea­sure sub­ject to the Ex­ces­sive Fines Clause,” the Con­gres­sion­al Re­search Ser­vice wrote in a re­port back in 2019 on a sim­i­lar drug pric­ing bill from House Speak­er Nan­cy Pelosi. The CBO added:

On one hand, the ex­cise tax could be viewed by a court as hav­ing the re­me­di­al func­tion of claw­ing back a por­tion of a drug man­u­fac­tur­ers’ gains de­rived from the sale of a drug dur­ing a non-com­pli­ance pe­ri­od, thus sug­gest­ing that it is not puni­tive. On the oth­er, the size of the tax and the fact that it is im­posed on­ly when a man­u­fac­tur­er is in a state of non-com­pli­ance could lead a court to con­clude that the tax is “at least in part …’puni­tive.'”

Rachel Sachs

But Rachel Sachs, a law pro­fes­sor at Wash­ing­ton Uni­ver­si­ty in St. Louis, who thinks PhRMA may file suit over the ne­go­ti­a­tions pro­vi­sions, not­ed there al­so may be a stand­ing prob­lem, par­tic­u­lar­ly if a com­pa­ny can’t show with suf­fi­cient speci­fici­ty that one of its drugs is like­ly to be the sub­ject of ne­go­ti­a­tion.

That could take sev­er­al years. If the bill pass­es, the HHS Sec­re­tary would have to pub­lish the list of drugs se­lect­ed for ne­go­ti­a­tion by Feb. 1 of the year which is two years be­fore the year at is­sue (e.g., list re­leased on Feb. 1, 2026, for price ne­go­ti­a­tions be­gin­ning in 2028), ex­cept the list would be pub­lished by Sept. 1, 2023, for ne­go­ti­a­tions start­ing in the first year, 2026.

Bri­an Sko­r­ney

Oth­ers like Baird an­a­lyst Bri­an Sko­r­ney told End­points that he thinks PhRMA et. al. “will try and find some­thing” to sue over, and he’s not sure that they’ll be suc­cess­ful.

“Ob­vi­ous­ly if a se­mi-rea­son­able ar­gu­ment could find its way to the Supreme Court, I could see the pro­vi­sion get­ting struck down. But I just don’t see it,” he said.

Sean Dick­son, di­rec­tor of health pol­i­cy at West health, told End­points that “giv­en that the Act’s ap­proach is sim­i­lar to the Med­ic­aid pro­gram where man­u­fac­tur­ers are re­quired to sell their drug at $0.00 and will soon ac­tu­al­ly be tak­ing a loss on cer­tain drugs, it seems un­like­ly that the rev­enue re­duc­tions here would con­sti­tute a col­orable claim while the long his­to­ry of Med­ic­aid re­bates does not.”

A spokesper­son from in­dus­try group BIO told End­points:

This is a large, com­plex piece of leg­is­la­tion that will have com­pli­cat­ed im­ple­men­ta­tion, un­in­tend­ed con­se­quences, and pow­er­ful co­er­cive penal­ties if it pass­es as ex­pect­ed.  While it is pre­ma­ture to com­ment on any spe­cif­ic po­ten­tial fu­ture lit­i­ga­tion on a piece of leg­is­la­tion that hasn’t been signed in­to law, BIO will con­tin­ue to ex­plore all av­enues to pro­mote and de­fend in­no­v­a­tive sci­ence in any venue.

“While it’s pre­ma­ture to spec­u­late be­fore the bill has passed, we will ex­plore every op­por­tu­ni­ty – in­clud­ing leg­isla­tive, reg­u­la­to­ry and le­gal – to make sure pa­tients have ac­cess to the med­i­cines they need and our in­dus­try can con­tin­ue to de­vel­op life­sav­ing cures and treat­ments,” a PhRMA spokesper­son added to End­points.

PhRMA al­so re­cent­ly took is­sue with the way in which De­moc­rats added an­oth­er op­tion for com­pa­nies that don’t want to com­ply with the ne­go­ti­a­tion process, which was first not­ed in a ver­sion of the bill cir­cu­lat­ed around Ju­ly 28.

A PhRMA spokesper­son told End­points and oth­er me­dia out­lets that, “Buried in the bill passed by the Sen­ate this past week­end, the leg­is­la­tion now in­cludes a sec­ond non-ne­go­tiable ul­ti­ma­tum for man­u­fac­tur­ers: pay the 95% tax or with­draw ALL their med­i­cines from the Medicare and Med­ic­aid pro­grams.”

Alex Law­son

But some ex­perts not­ed that while new, this ei­ther/or lan­guage may ac­tu­al­ly help small­er bio­phar­ma com­pa­nies, es­pe­cial­ly for those with on­ly one drug that doesn’t want to ne­go­ti­ate, or pay the tax, and can now just walk away from the ta­ble en­tire­ly.

Oth­ers who worked on craft­ing the bill al­so think that giv­en PhRMA’s track record in fight­ing state-based drug pric­ing leg­is­la­tion, this time will be no dif­fer­ent.

“Phar­ma nev­er gives up. They will fight to the last sec­ond and spend to their last dol­lar to pro­tect their rack­et. And still, we are go­ing to beat them,” Alex Law­son, ex­ec­u­tive di­rec­tor of the non­prof­it So­cial Se­cu­ri­ty Works, told End­points.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

No­var­tis un­veils 'US-first' strat­e­gy ahead of San­doz spin­off

Weeks after announcing the spinoff of generics arm Sandoz, Vas Narasimhan paints a picture of the new, slimmer Novartis — with a “US-first mindset,” he said at an investor event on Thursday.

The CEO unveiled ambitious plans to become a top-five player in the US by 2027 at Novartis’ “Meet the Management” event in Basel, Switzerland, which means ramping up clinical trials in the states and “building capability and talent, among other things.” The company’s also shooting for a top-three ranking in China.

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Pfiz­er sacks phar­ma com­pe­ti­tion in ear­ly NFL TV ad­ver­tis­ing sea­son

If pharma advertising had a fantasy football league, Pfizer would be crushing the competition. A dive into the National Football League’s TV commercial buys across early season games by iSpot shows a hefty lead with its Covid-19 Comirnaty vaccine ads.

More than 175 million impressions with $9.5 million in media spending put Pfizer in the top spot with a 65% share of voice across NFL pharma spending, according to the real-time TV ad tracker. In a distant second place is Bristol Myers Squibb’s Opdivo with 44 million impressions, $5.2 million in spending and a 16% share, followed by BMS’ Zeposia with 31 million impressions, $3.3 million in media buys and an 11% share.

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