title: Shortage of Peritoneal Dialysis Solution and the Food and Drug Administration's Response.
abstract: Although the number of new drug shortages has been lower in recent years than in the past, severe shortages have occurred that have affected large numbers of patients. A new law entitled the Food and Drug Administration Safety and Innovation Act was enacted in July of 2012, which requires companies to notify the Food and Drug Administration of anticipated shortages. This notification requirement has allowed the Food and Drug Administration to work closely with manufacturers earlier to mitigate and, often, prevent shortages. However, not all shortages are able to be prevented, and the shortage of peritoneal dialysis solution is one that has had a significant effect on patients. The Food and Drug Administration continues to use all available tools to address this shortage with manufacturers, including temporary availability of imported peritoneal dialysis solution from Ireland. Mitigating shortages is a top priority for the Food and Drug Administration, and communication with all stakeholders is essential.
authors.affiliation: Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland Valerie.Jensen@fda.hhs.gov.
authors.forename: Valerie
authors.initials: V
authors.lastname: Jensen
authors.affiliation: Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Douglas C
authors.initials: DC
authors.lastname: Throckmorton
mesh_terms: D003299:Cooperative Behavior; D015314:Dialysis Solutions / Q000600:supply & distribution*; D004345:Drug Industry / Q000458:organization & administration*; D006297:Health Services Accessibility / Q000458:organization & administration*; D006801:Humans; D033183:Interdisciplinary Communication; D007391:International Cooperation; D010530:Peritoneal Dialysis / Q000379:methods*; D062205:Strategic Stockpile / Q000458:organization & administration*; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015314:Dialysis Solutions
keywords: ESRD; chronic dialysis; chronic renal disease; dialysis; peritoneal dialysis