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Many patients with primary immunodeficiency (PI) rely on plasma-based therapeutics (namely, immunoglobulin) that cannot be manufactured without the donation of source plasma — the liquid, cell-free component of blood — by volunteers. It takes approximately 130 plasma donations to produce one year’s supply of immunoglobulin for an adult with PI.

IDF works to ensure adequate source plasma supply on two fronts.

  • Address barriers that prevent plasma donation, such as state regulations that do not align with federal standards and border control measures that adversely affect the ability of non-U.S. nationals to donate plasma.
  • Increase policymaker and public awareness of the need for plasma donation.

Why plasma donation access and awareness matters

A consistent supply of source plasma from donors is critical to maintaining the supply of plasma-derived therapies used by hundreds of thousands of individuals around the world. These therapies include immunoglobulin used by those with primary immunodeficiency and autoimmune disorders, clotting factors for those with hemophilia, and albumin used for burn and trauma victims.

Unfortunately, there are no synthetic substitutes for plasma-derived therapies. Only source plasma from volunteer donors can be used to create these life-saving medicines.

Barriers to plasma donation 

With demand for source plasma steadily rising, removing unnecessary or unintentional barriers to plasma donation is critical.  

Aligning state plasma donation regulations with federal standards 

Regulation of plasma donation centers falls to states, and some states have enacted regulations that exceed the U.S. Food and Drug Administration’s (FDA) plasma donation regulations. For example, California requires licensed medical professionals to perform some of the necessary tests on potential plasma donors, while the FDA requires appropriately trained, but not necessarily licensed, professionals to perform these tests. This federal standard allows plasma donation centers to operate efficiently with no impact on safety for either donors or recipients of donated plasma.  

Such added regulatory burdens mean it is more difficult and costly to open plasma donation centers in these states, and as a result, some states have no plasma donation centers at all. Harmonizing state regulations with the federal standard would increase the pool of potential plasma donors by removing geographical barriers. 

IDF's Director of State Policy, Jamie Sexton, provided testimony to the Connecticut legislature in support of harmonizing state regulations with federal standards in April 2022:

 

Overturning Border Control Policy that Limits Plasma Donations 

At the federal level, a recent policy change enacted by U.S. Customs and Border Protection (CBP) has adversely affected cross-border plasma donation. In June 2021, CBP made the determination that Mexican nationals with B1 or B2 visas could not be compensated for their time while donating plasma, classifying this activity as illegal “work for hire.” Previously, B1 and B2 visa holders were free to donate plasma and be compensated for their time, and it remains unclear why CBP reinterpreted this policy. As IDF estimates that up to 10% of the U.S. plasma supply comes from Mexican nationals who donate across the border, this barrier to donation could significantly limit source plasma supply. 

IDF is working with a broad coalition of plasma donation centers, plasma therapy manufacturers, and patient organizations to overturn this policy. IDF has also reached out to facilitate dialogue between the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Homeland Security (DHS) on the effects of the CBP policy.

Policymaker and public awareness of plasma donation 

Plasma Hero Facebook post.
Plasma Hero social media post
promoting plasma ​​​​​​donation.

While many people are aware of the need for blood donation, plasma donation has not received the same attention in the public sphere. Through its Plasma Hero campaign and the efforts of volunteer Plasma Ambassadors, IDF works to raise awareness among the general public about the need for and benefit of donating plasma.  

In addition, IDF supports awareness among policymakers through Advocacy Day and targeted Action Alerts.

 

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