FDA Letter Confirms IG Product Shortage

An FDA report has confirmed that despite an increased supply of immune globulin (Ig) products in recent years, an increased demand for Ig products has led to a shortage of Ig intravenous (IGIV) and Ig subcutaneous (IGSC) in the United States, which has affected hospitals and clinics across the country.

Shortages for drugs such as antibiotics, heart medications, and saline solution are becoming more common across the country, according to the Los Angeles Times. Yet IVIG’s complicated manufacturing process, its scientific uncertainty, and even certain financial motivations are just some of the nuanced factors leading to shortage of the drug, which is used for patients whose immune systems are compromised by viruses or cancer treatments. Even factors that wouldn’t ordinarily affect the availability of IVIG products, such as uneven product distribution across different localities, and logistics of contractual obligations, production delays, may have greater effects, the FDA said.

The FDA is working with the following applicants and manufacturers to help mitigate the supply situation for Ig products:

IVIG (Human)

• Asceniv
• Bivigam
• Carimune NF, Nanofiltered
• Flebogamma DIF 5% & 10%
• Flebogamma DIF 10%
• Gammagard Liquid
• Gammagard S/D
• Gammaked
• Gammaplex 5% & 10%
• Gamunex-C
• Octagam
• Panzyga
• Privigen

IGSC (Human)

• Cutaquig
• Cuvitru
• Gammagard Liquid
• Gammaked
• Gamunex-C
• Hizentra
• Hyqvia
• Xembify

IVIG is often the only therapy for certain genetic, life threatening conditions that disable the body’s infection-fighting function. Its intravenous form is licensed by the FDA for primary immunodeficiencies, Kawasaki disease, preventative care after bone marrow transplants, and chronic inflammatory demyelinating polyneuropathy.

Recently, the use of IVIG has expanded to include a wider variety of illnesses, including those that might increase risks to patients, reported the Los Angeles Times. The Plasma Protein Therapeutics Association reports that there was a 66% increase in distribution of the treatment between 2012 and 2018 across North America and Europe. This increased distribution contributed to the shortage.

Many health care providers, hospitals, and medical systems have taken steps to optimize limited supplies of Ig for patients, including lowering doses, delaying treatments, prioritizing based on medical need, and use of alternative therapies where those exist. Even patient advocates, pharmaceutical companies, and medical providers all support a range of different solutions, including collecting more plasma to increase the supply of drugs, according to the Cornell Daily Sun.

In the interview with the Cornell Daily Sun, patient advocate Michelle Vogel indicated that some providers have switched IVIG brands in shortage to brands with a larger supply. This was later confirmed by Dana Lynch, a representative from CSL Behring, which manufactures IVIG brands Privigen and Hizentra, according to the article.

“CSL Behring has had no manufacturing issues or supply disruptions related to Hizentra or Privigen and expects to supply the market significantly to help meet growing demand; however, we cannot fill the entire gap created by shortages of other manufacturers’ products,” Lynch told the Cornell Daily Sun.

According to the article, switching Ig products for non-medical reasons can result in problematic adverse events; however, more flexible pricing would help companies invest in expanding the supply of IVIG to meet demand even though it may complicate the affordability of the medications during the shortage.

In their letter released in August, the FDA encouraged medical systems to take an evidence-based approach to the shortage until it is resolved. Furthermore, if hospitals or other medical systems have only one Ig product contract, they may consider a second Ig product contract to improve resilience during and after the shortage.