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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,500+ biopharma pros reading Endpoints daily — and it's free.

Sanofi, Re­gen­eron boast PhI­II win with Dupix­ent in COPD, clear­ing first bar for ex­pan­sion

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,500+ biopharma pros reading Endpoints daily — and it's free.

Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Genen­tech to stop com­mer­cial man­u­fac­tur­ing at Cal­i­for­nia head­quar­ters

Genentech is halting commercial manufacturing at its California headquarters — and laying off several hundred employees.

The move is the result of a decision Genentech made in 2007 to relocate manufacturing operations from its South San Francisco headquarters location to other facilities or move the work to CDMOs, said Andi Goddard, Genentech’s SVP of quality and compliance for pharmaceutical technical operations, in an interview with Endpoints News. Genentech has made changes in capabilities and invested more in technology, so it doesn’t need as many large-scale manufacturing facilities as it did in the past, she said.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,500+ biopharma pros reading Endpoints daily — and it's free.

In­cyte wins ac­cel­er­at­ed ap­proval for PD-1 in rare skin can­cer

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.

A new study finds that many patient influencers are sharing prescription drug experiences along with health information.

So­cial me­dia pa­tient in­flu­encers ‘danc­ing in the gray’ of phar­ma mar­ket­ing, more clar­i­ty need­ed, re­searcher says

It’s no surprise that patient influencers are talking about their health conditions on social media. However, what’s less clear is what role pharma companies are playing, how big the patient influencer industry is, and just how is information about prescription drugs from influencers relayed — and received — on social media.

While University of Colorado associate professor Erin Willis can’t answer all those questions, she’s been researching the issue for several years and recently published new research digging into the communication styles, strategies and thinking of patient influencers, many of whom partner with pharma companies.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,500+ biopharma pros reading Endpoints daily — and it's free.

Drug short­age so­lu­tions brought be­fore Sen­ate Home­land Se­cu­ri­ty com­mit­tee

With more than 300 active drug shortages, the Senate Committee on Homeland Security and Governmental Affairs had its hands full on Wednesday with multiple experts testifying on drug shortages and possible solutions.

A picture of the shortage situation. presented by Erin Fox, an adjunct professor at the College of Pharmacy at the University of Utah, explained how some patients have died due to drug shortages, including with medication errors when substitutes were dosed incorrectly or when an emergency product was not available.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,500+ biopharma pros reading Endpoints daily — and it's free.