As a severe shortage of immune globulin (IG) continues, doctors, hospitals, and treatment centers nationwide are forced to cancel, ration, and cut doses. The drug is used to treat a broad range of life-threatening conditions that compromise the body’s immune system.
Manufacturers say the current shortage is the worst they have experienced since the drug has been on the market. While the supply of IG has increased in recent years, it has not been enough to keep up with demand, according to a statement by the U.S. Food and Drug Administration (FDA). The FDA does not have the authority to force companies to increase production of a drug.
IG’s popularity in treating off-label conditions, such as infertility and strep infections that have crossed the blood-brain barrier, also plays a role in the shortage. This has created tension between different communities that use the drug around prioritizing certain illnesses. In July, the Immune Deficiency Foundation said in a statement that doctors should find suitable alternative medicines where possible, because “for our population, there is no substitute.”
It can take seven months to a year to produce and supply plasma-based medications like IG to customers, and a one-year supply for a single patient requires more than 1,000 plasma donations. Since the plasma is processed at a central manufacturing plant before distribution, organizing blood drives to collect plasma won’t directly address the problem.
Current manufacturers include Takeda Pharmaceuticals, CSL Behring, Grifols, and ADMA Biologics. Grifols plans to open a new plant in the U.S., which will increase production capacity by more than 35%, but it won’t be operational until 2021.