UP­DAT­ED: CSL, plas­ma com­pa­nies win re­ver­sal on suit over Bor­der Pa­trol block­ade of visas for paid col­lec­tions

Last June, US Cus­toms and Bor­der Pro­tec­tion told Mex­i­cans seek­ing to sell their blood plas­ma at bor­der sites run by com­pa­nies such as CSL that they could no longer en­ter the US with “B‑1” busi­ness vis­i­tor visas.

The de­ci­sion de­liv­ered a blow to the com­pa­nies run­ning the sites, which un­til then, re­lied on the Mex­i­can donors to cross in­to the US and sell plas­ma at dozens of bor­der fa­cil­i­ties in ex­change for about $50 per do­na­tion. Com­pa­nies such as CSL and Gri­fols, which sued CBP, es­ti­mate that their cross-bor­der do­na­tions are re­spon­si­ble for about 5-10% of all US plas­ma col­lec­tions.

Neo­mi Rao

Even dur­ing the be­gin­ning of the pan­dem­ic, when B‑1 visa hold­ers were gen­er­al­ly pro­hib­it­ed from cross­ing the bor­der, the De­part­ment of Home­land Se­cu­ri­ty des­ig­nat­ed plas­ma donors as “es­sen­tial” and plas­ma col­lec­tion a “crit­i­cal in­fra­struc­ture in­dus­try.”

But last June’s de­ci­sion from CBP to no longer al­low the visas was based on the gov­ern­ment agency’s de­ter­mi­na­tion that do­nat­ing plas­ma should be con­sid­ered “la­bor for hire.” The plas­ma com­pa­nies, how­ev­er, main­tained that sell­ing plas­ma is a le­git­i­mate B‑1 busi­ness ac­tiv­i­ty and that they have re­lied on CBP’s pri­or long­stand­ing prac­tice of al­low­ing the B-1 visas.

While the com­pa­nies pre­vi­ous­ly lost their suit over the mat­ter due to lack of stand­ing, the US Court of Ap­peals for the DC Cir­cuit on Tues­day over­turned that pri­or rul­ing. Judge Neo­mi Rao ex­plains her opin­ion:

The dis­trict court con­clud­ed the plas­ma com­pa­nies were not with­in the ‘zone of in­ter­ests’ of the B-1 busi­ness vis­i­tor clas­si­fi­ca­tion set out in the Im­mi­gra­tion and Na­tion­al­i­ty Act (‘INA’) and sua sponte dis­missed the suit for lack of sub­ject mat­ter ju­ris­dic­tion. We re­verse. Whether the plas­ma com­pa­nies are with­in the statu­to­ry zone of in­ter­ests is a mer­its is­sue, not a ju­ris­dic­tion alone… More­over, the plas­ma com­pa­nies’ claims eas­i­ly fit with­in the zone of in­ter­ests of the B‑1 clas­si­fi­ca­tion, and there­fore they have a cause of ac­tion un­der the APA.

She al­so notes how the B‑1 busi­ness vis­i­tor clas­si­fi­ca­tion is de­signed to pro­tect both Amer­i­can work­ers fac­ing com­pe­ti­tion from im­mi­grant la­bor and Amer­i­can busi­ness­es ben­e­fit­ting from trans­ac­tions with B‑1 busi­ness vis­i­tors. And with that in mind, Judge Rao ex­plains how the plas­ma com­pa­nies,

eas­i­ly clear the low hur­dle of plead­ing in­juries with­in the zone of in­ter­ests pro­tect­ed by the B‑1 clas­si­fi­ca­tion. The plas­ma com­pa­nies de­pend heav­i­ly on B‑1 vis­i­tors in the bor­der re­gion. They have in­vest­ed hun­dreds of mil­lions of dol­lars to con­struct and staff dozens of fa­cil­i­ties geared to­ward col­lect­ing plas­ma from Mex­i­can donors. The plas­ma com­pa­nies made these in­vest­ments in re­liance on the large num­ber of Mex­i­cans who cross the bor­der to sell plas­ma: they al­lege Mex­i­can B‑1 vis­i­tors “com­prise the ma­jor­i­ty of donors at most of the bor­der cen­ters” and that the do­mes­tic pop­u­la­tion of the bor­der ar­eas could not sup­port the sub­stan­tial plas­ma col­lec­tion ac­tiv­i­ties of these fa­cil­i­ties.

Mov­ing for­ward, the ap­peals court said that the pri­or de­ci­sion should be re­mand­ed for fur­ther pro­ceed­ings con­sis­tent with this opin­ion.

Greg Boss, EVP and group gen­er­al coun­sel at CSL Lim­it­ed told End­points:

We are en­cour­aged by the Unit­ed States Court of Ap­peals for the Dis­trict of Co­lum­bia Cir­cuit’s rul­ing that plas­ma com­pa­nies have the le­gal right to chal­lenge the Cus­toms and Bor­der Pro­tec­tion (CBP) ban on plas­ma do­na­tion by Mex­i­can na­tion­als en­ter­ing the coun­try on a B1/B2 visa. We are al­so pleased that the Court of Ap­peals’ de­ci­sion ac­knowl­edges the im­por­tance of Mex­i­can plas­ma donors in pro­vid­ing this crit­i­cal re­source nec­es­sary to man­u­fac­ture life-sav­ing, plas­ma-de­rived ther­a­pies.

We await fur­ther in­struc­tion from the Unit­ed States Dis­trict Court and will con­tin­ue to chal­lenge the plas­ma ban and se­cure a more sta­ble plas­ma sup­ply for the hun­dreds of thou­sands of pa­tients de­pen­dent on plas­ma-de­rived ther­a­pies.

Ed­i­tor’s note: Up­dat­ed with com­ment from CSL.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

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Two Big Pharma companies are going to the mat over genetically modified mice in a licensing dispute.

Bristol Myers Squibb is suing Novartis in New York over a dispute concerning an evaluation, research and commercialization agreement stretching back to the late ’90s initially inked between Novartis and BMS’ predecessor Medarex. The deal in question allowed Novartis to use Medarex’s patented transgenic mice to develop therapeutic drugs. Novartis agreed to pay Medarex – and subsequently BMS – a royalty on sales of drugs it developed using the mice.

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Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.