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.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).

Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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