Will Restrictions At the Border Lead To IG Shortages? BY GINA SHAW
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or well over a year, pharmacists, physicians and patients have been dealing with sporadic shortages of immune globulin (IG) products, as the COVID-19 pandemic led to a significant decline in donations of the blood plasma that is the primary component of these therapies. According to the Plasma Protein Therapeutics Association (PPTA), plasma donations fell by 20% in 2020. Because the fractionation process that turns donated plasma into IG can take nine to 12 months from “needle to needle,” they expected the shortages to be much worse, but the IG supply in the United States remained relatively robust compared with other countries. A lack of cross-border plasma donations is not helping. Because Mexico does not allow monetary compensation for plasma donations, many Mexican citizens cross the border regularly to donate plasma in the United States. On June 15, the U.S. Customs and Border Patrol (CBP) agency announced that it was stopping that practice and would no longer permit Mexican citizens to cross the border on temporary visas to sell blood plasma. “Selling plasma constitutes labor for hire in violation of B-1 nonimmigrant status, as both the labor (the taking of the plasma) and accrual of profits would occur in the U.S. with no principal place of business in the foreign country,” the agency said in a statement. The U.S.–Mexico border was closed to nonessential travel through much of the pandemic, so plasma donation centers at the border already experienced significant declines in donations, said Matthew Hotchko, PhD, the president of the Marketing Research Bureau, which supplies market data and intelligence on the global blood and plasma industry. “There
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had already been a steep dropoff. I don’t have exact figures, but I believe somewhere between 70% to 80% of plasma donors coming from Mexico had already dropped out of the regular donor pool because of the challenge of getting across the border.” Before the pandemic, the approximately 40 border centers contributed about 10% to 12% of total U.S. plasma collections, with most coming from those living in Mexico, Dr. Hotchko said. He estimated that between the border closures and the new CBP ruling, plasma donations at border centers have been reduced by more than half. “I would say that probably about 3% to 4% of total plasma collections in the U.S. are now coming from those border centers after the recent CBP policy change.” Organizations that advocate for patients with primary immunodeficiencies (PIs), such as the Immune Deficiency Foundation, have urged the Biden administration to rethink this policy change. “This action could reduce the plasma supply used to make lifesaving therapies by 5% to 10%,” said IDF vice president of public policy Lynn H. Albizo, JD, in a letter sent in June, to Health and Human Services Secretary Alejandro Mayorkas. “If these changes are implemented, we will see further pressure on the supply of plasma that will jeopardize the health of Americans with PI and other conditions.” The PPTA, which represents manufacturers of IG and other plasma products such as CSL Behring, Grifols and Takeda, also issued a statement. “The change by U.S. Customs and Border Protection to limit the ability of people to cross the border to donate plasma is bad policy that risks American lives. Nearly 125,000 people in the U.S. with rare diseases, as well as countless others facing trauma and emergency medical needs every day, rely on medicines that are only available because of the com‘I would have said [plasma mitment of dedicated plasma donors, and this new policy collections would stabilize] by end risks hindering the availability of these lifesaving medicines.” As of Dec.15, the policy was still in place. “PPTA conof this year but the delta variant has tinues to be actively engaged with policymakers and the thrown a monkey wrench into that, administration to reverse CBP's policy change, as do sevand it might be mid-2022 before we eral national and international patient advocacy groups see supply growing again.’ and PPTA member companies. PPTA feels strongly that —Matthew Hotchko, PhD this restriction risks patients' lives by stopping dedicated
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