Pharmaceutical companies have launched a legal fight against the U.S. government over a policy banning certain visa holders from selling blood plasma, a crucial tool used to treat numerous autoimmune and neurological diseases.
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Mexican nationals who enter the United States on visitor visas donate up to 10% of plasma collected in the U.S., and the companies that collect the plasma are fighting the Customs and Border Protection policy that would curtail the paid donations for B-1 and B-2 visitor visa holders in court.
The plaintiffs named in the case, which was refiled in January after District Judge Tanya Chutkan upheld the “plasma ban” in December, are plasma donors who donate at centers along the U.S.-Mexico border, employees of border center affiliates of two major plasma companies, Australia-based CSL Ltd. and Spain-based Grifols SA, and patients who rely on plasma therapies.
“The Plasma Ban also needlessly damages public health by making fewer plasma-derived therapies available to patients at the most inopportune time — when the critical need for such therapies continues to grow rapidly and U.S. plasma therapeutic suppliers work to rebound from the decrease in plasma donation throughout the U.S. over the last two years due to the pandemic,” the plaintiffs argued.
Two advocacy organizations representing patients who rely on plasma donations wrote on behalf of plaintiffs of the “irreparable harm that patients will suffer” due to the CBP policy announced last June that banned visitor visa holders from getting paid for donating.
Before the policy went into effect, people in Mexican border communities would be able to cross over on their visitor visas to donate plasma for about $50. The allowance for Mexicans to donate has helped bolster a dwindling national supply of plasma that has worsened during the COVID-19 pandemic.
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The average number of donations per donation center across the U.S. in the first few months of 2021 was down approximately 11% compared to last year, further deepening the nearly 20% decline in donations in 2020 compared to the year prior, according to the Plasma Protein Therapeutics Association. The shortage caused plasma prices to soar in 2020 and early 2021, with some El Paso clinics promising to pay $700 a month for those willing to donate twice a week, every week, the maximum allowed by the Food and Drug Administration.
Human blood plasma is used to manufacture therapies for roughly 125,000 Americans who suffer from a range of conditions such as autoimmune disorders, cancer, neurological disorders, hemophilia, and other blood conditions.
