A National Increase in the Demand of Immune Globulin

We take pride in Helping Healthcare Care^© and understand your concerns and the importance of providing your patients with their immune globulin (IG) product. Since the U.S. Food and Drug Administration (FDA) approved the first intravenous IG (IVIG) product in 1981, IG has experienced a sustained record of near-continuous demand growth. More than 35 years after they were first introduced, demand for IG products continues to grow more than 8 percent a year. In 2018, as it has over each of the past several years, demand for IG products grew by more than 7 million grams. Collectively, IVIG and subcutaneous IG (SCIG) product shipments last year approached 88 million grams.

Even though there are currently 15 IG products available today, this demand growth nevertheless poses two special challenges for IG manufacturers: 1) they must forecast and invest in plasma collection facilities to ensure sufficient additional donor plasma is available to process into IG products, and 2) they must plan, invest and provide adequate lead time to construct and secure regulatory approval to operate new or expanded fractionation (how plasma is manufactured into IG products) and related IG production facilities. To meet these growing demands, IG manufacturers are making great strides to increase production of this lifesaving treatment in order to meet the needs of our most precious patients.

On the CBER-Regulated Products: Current Shortages list, GAMMAGARD LIQUID^©, CUVITRU^© and Gammaplex^© were identified as currently unavailable due to increased demand. "Shortages of drugs and biologics pose a significant public health threat, delaying, and in some cases even denying, critically needed care for patients. Preventing shortages remains a top priority for FDA," as stated in FDA Facts: Drug Shortages in the United States.

Unfortunately, we cannot project when or which products will become available. However, we are employing our Controlled Volume Measures™ system in order to provide critical-care patients with their lifesaving IG products. With the help of our manufacturing partners, we will continue to furnish you with the latest IG industry and product information.

Please know that your patients are very important to us. We sympathize with you and understand the difficulty of having to inform them that future treatments with their brand of IG may not be possible.

Let us work together to find solutions for your patients. Our Wow! Customer Care and Sales teams are here to help. Please call us at (800) 843-7477.

Sincerely,
Patrick M. Schmidt - Chief Executive Officer