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Federal Lawmakers Urge Action on Intravenous Saline Shortages

February 07, 2018

In a bipartisan, bicameral Congressional letter, federal lawmakers expressed great concern about nationwide drug shortages. They called on the U.S. Food and Drug Administration (FDA) to take all available actions to address current intravenous (IV) saline shortages that are creating problems and anxiety for hospitals, providers, and patients.

Specifically, the letter urges the FDA to use every authority to:

  • Present a plan that ensures immediate and sustained production of IV bags
  • Provide sufficient guidance to mitigate cost increases

Cosigned by 30 U.S. senators and 64 U.S. representatives, including four from Pennsylvania, the letter cites significant damage to manufacturing facilities in Puerto Rico as a result of Hurricane Maria. The damage has impacted the supply of critical therapies, and worsened shortages of Sodium Chloride 0.9% Injection Bags, amino acids, and other IV fluids.

The lawmakers stressed the urgency of addressing the ongoing shortage of medical products as a matter of public health, especially in the face of the height of a severe flu season.

The federal officials recognized ongoing efforts by the FDA, including allowing the importation of saline products from other countries and approving new saline products. However, they did ask for clarification about several key issues:

  • Steps being taken to prevent new shortages
  • The nature of the approval of new suppliers of saline
  • The timeline for access to new products
  • Additional tools or authorities the FDA requires to increase the supply
  • Steps being taken to create contingency strategies
  • Coordination to ensure the rebuilding of Puerto Rico’s critical infrastructure

FDA Commissioner Scott Gottlieb, M.D. has testified before Congress on multiple occasions in recent months and engaged in an ongoing dialogue. The FDA maintains a drug shortage website with all relevant information about the IV saline shortage. FDA Commissioner Gottlieb issued a statement on February 1, outlining ongoing efforts to mitigate the impact of saline shortages during the flu season. Strategies cited include:

  • Reviewing the expiration dates of certain products
  • Importing products from foreign facilities
  • Engaging providers, manufacturers, and distributors to address supply gaps

HAP thanks Congressmen Charlie Dent (R, PA-15), Mike Kelly (R, PA-03), Keith Rothfus (R, PA-12), and Lloyd Smucker (R, PA-16) for signing on to the letter to the FDA. The association urges continued vigilance by Congress to ensure the FDA is pursuing all avenues to ensure access to needed medical supplies.

HAP’s emergency preparedness team has been working with member organizations and the state Department of Health to assess regional shortages, and will continue to do so. Hospitals are closely monitoring the shortage and implementing appropriate protocols and practices. For more information, contact Mark Ross, HAP’s acting vice president, emergency preparedness.

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