Importing Drugs to Address Shortages

By: Capt. Valerie Jensen, R.Ph.

Patients deserve and expect medicines that are available when they need them. The FDA works hard to prevent shortages of the medicines patients trust and rely on, and we do all we can to mitigate them whenever necessary. 

Over the past several months, the FDA has been working to resolve the shortages of injectable drugs used to make total parenteral nutrition, or TPN. These shortages are greatly affecting children’s hospitals. They rely on this treatment for vulnerable patients who cannot get the nutrition they need through eating and must receive it intravenously to survive. 

It’s heartbreaking for us to hear that these hospitals across the country are struggling to provide the proper nutrition in the face of these shortages. As a mom, my heart goes out to the parents of these infants and children who are struggling to survive. 

When my team and I first learned that American Regent/Luitpold, the U.S. manufacturer that makes many of the TPN components, was going to voluntarily shut down to resolve its quality issues, we determined which drugs were made only by American Regent and which ones were also made by other manufacturers. For those that had other manufacturers, we reached out to those firms to see if they were able to increase their production. However, while the manufacturers were able to do so, they would not be able to meet the total supply needs. 

Shortages of these drugs – such as the trace elements injection, sodium phosphate, potassium phosphate, calcium, zinc and other IV nutrition drugs – ­are particularly challenging. To supply them to the entire country, it was clear that our best option was to ask a foreign company to dramatically increase its production. Immediately, we began working with our regulatory counterparts around the world to search for a foreign manufacturer that was willing and able to supply products. 

Once we identified the potential manufacturers who were willing and able to help with these shortages – including Fresenius Kabi USA, LLC (FK USA) – we worked to ensure that the drugs are quality products and would not pose undue risk to U.S.patients. We reviewed many aspects of the companies’ processes and operations, including: 

  • the manufacturing practices at the manufacturing facilities, as well as at the facilities where the active pharmaceutical ingredients, or APIs, are produced;
  • the history of inspections of those facilities from our own inspections or those of  our regulatory counterparts; and
  • the sterilization methods used for injectable drug products to ensure they met FDA standards. 

We then met with FK USA and the other firms to determine: 

  • a distribution and shipping plan;
  • how adverse events will be reported to FDA;
  • how an outline for a Dear Health Care Provider letter, which highlights important information for doctors and pharmacists, will be structured; and
  • product labeling. 

While this might seem like a long road to take in resolving a shortage, it is an important process to protect the health of patients during a shortage. We expect these importations to address the current supply disruption over the coming weeks and we will remain vigilant in monitoring the supplies of these drugs until patient needs are fully met.   

Capt. Valerie Jensen, R.Ph., is the Associate Director of the Drug Shortages Program in FDA’s Center for Drug Evaluation and Research

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