The U.S. Food and Drug Administration has replied to a letter from the NRAA that expressed concern over the shortage of peritoneal dialysis (PD) solution. The FDA letter noted NRAA’s concerns and stressed the FDA’s commitment to solving drug shortages.
"FDA shares your concern and understands that PD is essential therapy in the treatment of kidney failure, " wrote Valerie Jensen, R.Ph., associate director of the Drug Shortages Staff for the Center for Drug Evaluation and Research at the FDA. "We understand the significant impact PD drug shortages are having on healthcare providers and their patients and we are doing everything within our authority to help alleviate the shortage and increase supplies in the marketplace. "In response to the NRAA's request for the FDA to consider importing PD solutions from other countries, the FDA also said it is "actively exploring alternate sources to help have additional product available as soon as possible to meet patient needs."
The FDA said it considers working with companies that manufacture drugs that are approved in non-U.S. markets when there is a shortage of a medically necessary drug. However, the FDA must identify an international firm willing to import a drug to the U.S., and evaluate the drug, its labeling, and its manufacturing site for safety.
"The review processes are completed as expeditiously as possible while still ensuring that the alternate source is of adequate quality and that the drug does not pose significant risks for U.S. patients," the FDA said in the letter. "While the agency expedites this process as much as possible, we also need to ensure the safety and efficacy of products introduced into the U.S. market."