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Advisory Committee on Blood Safety and AvailabilityStatus of Immune Globulin Intravenous (IGIV) ProductsIn the last few months, the Department of Health and Human Services (HHS) and its agencies, the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS), have received several reports that some health care providers have had difficulty obtaining Immune Globulin Intravenous (IGIV), a.k.a. IVIG, products. HHS is actively working with manufacturers, health care providers, patient groups, and other government entities to better understand the present situation and to assess potential actions. Although there are reports from some health care providers of difficulties with IGIV product distribution and pricing, we do not find evidence of an overall shortage of IGIV at present, or indicators of an impending shortage. Reports from providers indicate that they have encountered problems obtaining specific brands of IGIV for some patients, including privately insured patients and those covered by Medicare. In some cases treatment locations have reportedly shifted from physician offices to hospital settings. Some hospitals have reportedly experienced difficulty in obtaining the physicians� IGIV product of choice for the patient. At the same time, prices for IGIV have been on an upward trend, most notably in the secondary (or resale) market. From discussions with stakeholders, it is clear that a number of changes have been occurring in the marketplace; however, their relationship to the issues reported by some providers is not fully understood, but will be monitored;
We are working with stakeholders to further assess the evolving marketplace. At this time, we believe there is sufficient supply of IGIV for patients who need it. Under manufacturers� allocation processes, physicians might best serve their patients by communicating their supply needs directly to manufacturers and by ensuring that IGIV treatment is prioritized toward FDA labeled use and those diseases or clinical conditions that have been shown to benefit from IGIV based on evidence of safety and efficacy, and for which safe and effective alternative therapies are not available. It is a HHS goal to work with partners in the marketplace to help prevent or alleviate shortages of medical products, including IGIV. We are seeking additional information on the current availability of IGIV products. We are asking health care providers and patients who experience difficulty obtaining IGIV to report their experiences (e.g. denial of treatment, delay of treatment, forced reduction in dosage, etc.) by sending an email to FDA at CBERProductshortages@cber.fda.gov. Those without email access may call (800) 835-4709. Reports related to Medicare-related coverage and access to care should call 1-800-MEDICARE. |
Last Revised: August 11, 2005