ICYMI: Kaptur, Brown send bipartisan letter to FDA regarding shortage of IV saline at height of deadly flu season

February 5, 2018
Press Release
29 Senators and 63 Representatives request information regarding FDA actions to address shortage of vital medicines

Washington, D.C. – Congresswoman Marcy Kaptur (D-OH) and Senator Sherrod Brown (D-OH) wrote to Food and Drug Administration (FDA) Commissioner Scott Gottlieb regarding the current shortage of IV saline and other critical medical products. The shortage resulted from the devastation Hurricane Maria wrought on Puerto Rico’s many major manufacturing facilities. Months after the storm, many of these factories still lack full and consistent access to power. At the height of the deadliest flu season in recent history, the shortage threatens to further endanger public health.

The lawmakers’ letter urges the FDA to use all tools at its disposal to address these dire shortages, and calls for information regarding the FDA’s response to the shortage of IV saline. IV saline is used for critical medical procedures, including rehydration and delivery of medications.

Key excerpts from the letter:

“The ongoing shortage of medical products manufactured in Puerto Rico, specifically small volume IV fluid bags, has created a nationwide public health scare during the height of a severe flu season,” said the letter.

“…a shortage of IV fluids was documented by the FDA and has persisted since January 2014. As of October 2017, no drug or medical product manufacturers in Puerto Rico were operating at higher than 70 percent capacity. Baxter is one of only three U.S. companies that manufacture IV bags, and the last of their facilities in Puerto Rico were only recently reconnected to the fragile power grid,” the letter continued.

“To avoid any further harm to consumers, we request that the FDA use every authority at its disposal to address this crisis and present a plan to ensure immediate and sustained production of IV bags that also provides sufficient guidance to mitigate cost increases,” the letter concluded. “…providers in our states have voiced concerns over the uncertainty of when these products will become available and when a long-term solution to this shortage will be implemented.”

The letter was signed by a bipartisan group of 29 U.S. Senators and 63 U.S Representatives. Read the entire letter here.

What did the letter ask for?

  1. What steps has the FDA taken to prevent new shortages of other medical products manufactured in Puerto Rico?
  2. Is the approval of new suppliers of saline permanent or temporary, and what would trigger a change in this status as current suppliers eliminate shortages?
  3. When does the FDA expect these products to become widely available?
  4. Does the FDA have the tools necessary to increase the nation’s supply of saline and other IV fluids? If not, will you please provide detailed ways in which Congress can assist?
  5. What steps is the FDA taking to ensure manufacturers are creating contingency strategies to avoid future shortfalls? 
  6. Is the FDA coordinating with other agencies aiding in Puerto Rico’s recovery to ensure the rebuilding of its critical infrastructure adequately address the operational needs of pharmaceutical and medical device manufacturers?