- The FDA has enabled importation of certain essential nutritional medications to combat a major shortage. These medications are specifically for fragile infants who cannot consume food or drink through normal means.
- The critical shortage stems from the temporary shutdown of American Regent/Luitpold, a key manufacturer of these critical drugs, due to quality issues. The scarcity also affects cancer patients and individuals who had undergone gastrointestinal surgeries.
- In response to the shortage, the FDA sought foreign suppliers to import the necessary medications. Fresenius Kabi USA, located in Illinois, currently imports select ingredients for the feeding solution from a plant in Norway.
- The shortage of crucial medications is not a recent phenomenon, with similar crises observed in 2011 and 2012, particularly regarding certain cancer treatments which needed emergency response from both the Obama Administration and the FDA.
The U.S. Food and Drug Administration (FDA) has recently taken exemplary actions to tackle a threatening scarcity of essential nutritional medication for fragile infants. The effort has resulted in the FDA enabling the importation of key injectable nutritional drugs, a move essentially aimed at safeguarding the health of premature newborns.
Overview of the Situation
The critical products that are currently scarce are indispensable injectable drugs, which are part of intravenous feeding solutions. These are noted by the FDA as being in a “critical shortage” phase.
National hospitals have a dependency on this form of feeding solution for their treatment of premature infants who are not capable of eating or drinking naturally or for those going through different deficiencies. This shortfall has also notably had an impact on cancer patients and individuals who have undergone gastrointestinal surgeries, and likewise cannot consume food or drink through normal means.
Source of the Shortage
The origin of the crisis can be traced back to the temporary shutdown by American Regent/Luitpold towards the end of 2012, according to an FDA press statement. Being a key manufacturer of these vital products, the temporary discontinuation of the company’s operation due to “quality issues that included particulate matter in its injectable products” has contributed significantly to the drug shortage.
“Since the initial phase of these scarcity, the FDA has shown great concern about the decreasing supply of injectable nutrition products and its impact on children’s hospitals caring for susceptible patients,” Valerie Jensen, the associate director of the drug shortages program in the FDA’s Center for Drug Evaluation and Research, mentioned. It is believed that the importation of these crucial injectable nutrition drugs will successfully meet current demand over the subsequent weeks.
Responding to the Scarcity
Upon learning about American Regent/Luitpold’s temporary shutdown, the FDA started exploring foreign suppliers. One such company, Fresenius Kabi USA, located in Illinois, is currently importing specific ingredients of the feeding solution to the United States from a plant based in Norway, according to the FDA.
The FDA has also stated, “Other producers of TPN components, including Hospira Inc., of Lake Forest, Ill., are also contributing to the surge of supplies of these critical drugs.”
This crisis is not the first instance of drug shortages jeopardizing U.S. patients in recent year. Specifically, in 2011 and 2012, shortages of certain cancer treatments called for emergency response from both the Obama Administration and the FDA.
If you’d like to learn more about intravenous feeding, visit the U.S. National Library of Medicine.