Large plas­ma com­pa­nies CSL Behring and Gri­fols re­cent­ly sued US Cus­toms and Bor­der Pa­trol, which last sum­mer stopped al­low­ing Mex­i­can cit­i­zens from cross­ing in­to the US on tem­po­rary visas to sell their blood plas­ma.

The ban, ac­cord­ing to the Aus­tralia- and Spain-based com­pa­nies, is based “sole­ly on CBP’s new­found de­ter­mi­na­tion that do­nat­ing plas­ma is some­how ‘la­bor for hire,'” and it means that there may be plas­ma short­ages, ac­cord­ing to the suit re-filed in DC Dis­trict Court. The com­pa­nies pre­vi­ous­ly lost a pri­or suit last year as the judge dis­missed their com­plaint for lack of stand­ing.

CSL op­er­ates a net­work of 15 plas­ma col­lec­tion cen­ters near the south­ern bor­der in Texas and Ari­zona, with plans to open two more cen­ters short­ly, in­clud­ing its first on the Cal­i­for­nia bor­der. Gri­fols, mean­while, op­er­ates 24 such cen­ters in Ari­zona, Texas and Cal­i­for­nia, ac­cord­ing to the suit. The com­pa­nies es­ti­mate that these cross-bor­der do­na­tions are re­spon­si­ble for about 5-10% of all US plas­ma col­lec­tions.

“Such a dis­rup­tion in plas­ma do­na­tions is es­pe­cial­ly crit­i­cal now, when more plas­ma than ever is re­quired to meet the grow­ing need for plas­ma-based ther­a­pies, and when the Unit­ed States has al­ready suf­fered a 20% in­dus­try-wide drop in do­na­tions due to the pan­dem­ic,” the suit says.

The com­pa­nies claim that CBP “need­less­ly pulled the rug out from un­der plas­ma in­dus­try donors and em­ploy­ees as well as the pa­tients” as plas­ma is a cru­cial in­gre­di­ent for some treat­ments for se­ri­ous dis­eases that af­fect more than 125,000 Amer­i­cans, in­clud­ing pri­ma­ry and sec­ondary im­mune de­fi­cien­cies, res­pi­ra­to­ry dis­eases, neu­ro­log­i­cal dis­or­ders, and he­mo­phil­ia and oth­er blood dis­or­ders.

“For in­stance, im­munoglob­u­lin ther­a­py for a sin­gle pa­tient suf­fer­ing from one of a host of pri­ma­ry and sec­ondary im­mune de­fi­cien­cies re­quires about 130 do­na­tions of plas­ma an­nu­al­ly, and a year of ther­a­py for a sin­gle he­mo­phil­ia pa­tient re­quires about 1,200 do­na­tions,” the suit says.

But since last June, CBP has de­cid­ed that 30 years of prece­dent should be over­turned, and the agency sent back all po­ten­tial donors from Mex­i­co, claim­ing the do­na­tions are part of this “la­bor for hire” op­er­a­tion.

The com­pa­nies, how­ev­er, claim that the fact that a donor re­ceives pay­ment as part of the do­na­tion process “is in­ci­den­tal to the ser­vice trans­ac­tion and does not some­how trans­form the re­la­tion­ship in­to any­thing ‘akin to em­ploy­ment or con­tract work.'”

Ac­cord­ing to ProP­ub­li­ca, be­fore the pan­dem­ic, donors could make about $4,000 an­nu­al­ly if they do­nat­ed as of­ten as pos­si­ble. US law al­lows for 96 do­na­tions per year, where­as Eu­ro­pean law al­lows for 33 do­na­tions per year. Since the pan­dem­ic, those prices have gone up as do­na­tions be­come more scarce.

The ban has had a par­tic­u­lar­ly out­sized ef­fect on sev­er­al of the plain­tiffs, in­clud­ing Kevin Ras­mussen, who is a reg­u­lar plas­ma donor at CSL Plas­ma’s cen­ter in Dou­glas, AZ. He do­nates plas­ma about eight times per month, the max­i­mum per­mit­ted by FDA reg­u­la­tions, in or­der to help sup­port his fam­i­ly and wife, who has a chron­ic health con­di­tion and is of­ten un­able to work, the suit says.

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

While colder temperatures are fast approaching, the situation surrounding the rise of energy prices in Europe is hitting businesses of every kind, including generic drug manufacturers.

Medicines for Europe, a group that represents the generic industry on the continent, sent a letter addressed to energy ministers and commissioners concerning inflation and the costs of energy on the supply of generic medicines.