Thursday, July 11, 2019

Plasma shortage alert from the IDF--the Immune Deficiency Foundation

Patients with primary immunodeficiencies don't produce antibodies, and depend on immunoglobulin, one of the primary plasma products produced by donated plasma (the other is albumin, and there are other life-saving and life-improving pharmaceuticals as well).  The IDF is a foundation dedicated to this complex of diseases:

Immune Deficiency Foundation
Dedicated to improving the diagnosis, treatment and quality of life of persons with primary immunodeficiencies

In recent years immunoglobulin has been used around the world to treat other immune deficiency diseases also, as well as to modulate the immune systems of people with auto-immune diseases.

But shortages occur, because the U.S. remains the primary supplier of donated plasma (since it is legal to compensate plasma donors in the U.S., but not everywhere...)

Here's a blog post from John Boyle, the IDF president

Immunoglobulin Product Availability Issues: The Sky Is Not Falling but the World Needs More Plasma
"IDF is working with those who are seeking to increase yields of Ig from plasma, introduce new fractionation technologies, grow plasma donations at collection centers, and more, but those are long term solutions.

"Ultimately, the issue is that the world needs more plasma, and the only good way to make that happen is to collect more plasma. The one thing that we can all do right now is to encourage people to become regular plasma donors if there’s a collection center anywhere near them."

"Biologic" medicines are regulated by the Food and Drug Administration's
Center for Biologics Evaluation and Research (CBER)

"CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products."

Here is their list of CBER-Regulated Products: Current Shortages
"GAMMAGARD LIQUID® Immune Globulin Infusion (Human) is currently available, though patient shipping schedules may be impacted as continued high demand exceeds production plans and available inventory."
which they attribute to: "Demand increase in the drug or biological product."

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