Letter to the Hon. Scott Gottlieb, Commissioner of the Food and Drug Administration - Klobuchar Urges the Food and Drug Administration to Take Additional Action to Alleviate Shortage of IV Bags and Saline Solution

Letter

Dear Commissioner Gottlieb,

I am writing to urge the Food and Drug Administration (FDA) to examine any additional actions the agency can take to alleviate the shortage of IV bags and saline solution in the United States.

As you know, our healthcare system depends on saline solution to treat patients. Saline solution is needed to hydrate and deliver critical medications to patients with the flu and other serious illnesses. This year's flu season has been unusually severe, increasing the need for saline in Minnesota and across the country. For the first time in thirteen years, the Centers for Disease Control and Prevention (CDC) has reported that every part of the continental United States has experienced widespread flu activity.[1]

The United States has faced a saline shortage since at least 2014, when the FDA added saline solution to the drug shortage list. In light of this shortage, I called for an investigation of possible collusion by saline manufacturers and have supported efforts to determine the causes of the shortage and whether anticompetitive behavior has increased healthcare costs. Hurricane Maria exacerbated this shortage, as several saline production facilities in Puerto Rico temporarily shut down just as hospitals around the country were preparing for flu season.

As you know, it has been difficult for hospitals and other healthcare providers to obtain the supply of IV bags and saline that they need. In Minnesota, some hospitals and clinics are operating at "contingent capacity" because of the shortage--meaning that current practices are not consistent with hospital guidelines.[2] Doctors and nurses must now substitute oral medications wherever possible and spend additional time manually injecting drugs for patients when IV bags are unavailable.

While I appreciate the FDA's recent actions to increase the supply of saline--which include authorizing two new companies to sell saline products in the United States and allowing some temporary importation of saline products--I urge you to examine what more the FDA can do under its existing authority to end this shortage. In addition, I ask that you please provide recommendations regarding any legislative changes that would allow the FDA to address drug shortages more effectively, including those caused by natural disasters or other sudden supply chain disruptions.

Thank you for your prompt attention to this critical issue.

Sincerely,

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