WASHINGTON, D.C. – U.S. Sen. Sherrod Brown (D-OH) joined 29 Senators and 63 Representatives in a letter 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 and, along with one of the potential deadliest flu seasons in recent history, the shortage has fueled a public health scare. In some instances, it took months for manufacturers to be reconnected to Puerto Rico’s fragile power grid. While the FDA has already taken immediate steps to address the shortage, Congress and the Administration must work in unison towards a long-term solution.

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

“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 Brown and his colleagues in the letter. “We understand the FDA has taken steps to attempt to remedy this crisis by allowing the importation of saline products from other countries and by also approving new saline products. However, 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.”

Read the entire letter here.

The letter specifically asks:

  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?

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