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Rubio, Blumenthal, González-Colón, Kaptur Lead Bipartisan Letter to FDA Regarding Shortage of IV Saline at Height of Deadly Flu Season

Feb 2, 2018 | Comunicados de Prensa

Washington, D.C. U.S. Senators Marco Rubio (R-FL) and Richard Blumenthal (D-CT), and Congresswomen Jenniffer González-Colón (R-PR) and Marcy Kaptur (D-OH), led 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. The letter commends the FDA for the steps it has already taken immediate to address the shortage, but Congress and the Administration must work in unison towards a long-term solution.
 
The lawmakers’ letter urges FDA to use all tools at its disposal to address the 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.

“All Florida’s hospitals recognize and appreciate Senator Rubio’s leadership in addressing the current nation-wide saline shortage,” said Florida Hospital Association President Bruce Rueben. “This is a growing problem that threatens our ability to care for patients at a critical stage of the flu season. The letter spearheaded by Senator Rubio is a great example of collaborative, bipartisan Congressional resolve to eliminate this shortage as quickly as possible. Thank you Senator Rubio for your leadership and quick follow up on an issue that must be resolved to be sure Americans have access to the best possible care.”

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.”
“Puerto Rico plays an important role in supporting American public health. Nearly 80 pharmaceutical companies in Puerto Rico manufacture approximately 10 percent of all drugs consumed by Americans, and this sector represents an important part of the commonwealth’s economy… These shortages have underscored Puerto Rico’s critical role after major manufacturing facilities were damaged or temporarily closed in the wake of Hurricane Maria. In light of this, we urge you to use all tools at your disposal to address these dire shortages…”
 
“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 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?

A full list of additional cosigners below:

Senate (28): Baldwin (D-WI), Barrasso (R-WY), Boozman (R-AR), Brown (D-OH), Carper (D-DE), Cassidy (R-LA), Collins (R-ME), Coons (D-DE), Cornyn (R-TX), Duckworth (D-IL), Enzi (R-WY), Gillibrand (D-NY), Harris (D-CA), Hoeven (R-ND), Isakson (R-GA), Johnson (R-WI), Lankford (R-OK), Merkley (D-OR), Murphy (D-CT), McCaskill (D-MO), Menendez (D-NJ), Moran (R-KS), Nelson (D-FL), Perdue (R-GA), Rounds (R-SD), Tester (D-MT), Thune (R-SD), and Wicker (R-MS).

 
House (61): Allen (R-GA), Barragan (D-CA), Blunt Rochester (D-DE), Carter (R-GA), Crowley (D-NY), Curbelo (R-FL), DeLauro (D-CT), DelBene (D-WA), Dent (R-PA), DeFazio (D-OR), Diaz-Balart (R-FL), Espaillat (D-NY), Fudge (D-OH), Gabbard (D-HI), Gonzalez (D-TX), Goodlatte (R-VA), Grijalva (D-AZ), Gutierrez (D-IL), Higgins (D-NY), Johnson (D-GA), Joyce (R-OH), Keating (D-MA), Kelly (R-PA), Kilmer (D-WA), King (R-NY), Larson (D-CT), Lewis (D-GA), Lipinski (D-IL), Lieu (D-CA), , Lofgren (D-CA), Lowenthal (D-CA), Lynch (D-MA), Carolyn Maloney (D-NY), Sean Maloney (D-NY), McGovern (D-MA), McSally (R-AZ), Meng (D-NY), Moulton (D-MA), Nadler (D-NY), Norton (D-DC), O’Rourke (D-TX), Payne (D-NJ), Pingree (D-ME), Pocan (D-WI), Raskin (D-MD), Ros-Lehtinen (R-FL), Rothfus (R-PA), Roybal-Allard (D-CA), Serrano (D-NY), Smith (R-NJ), Smucker (R-PA), Soto (D-FL), Thompson (D-CA), Tonko (D-NY), Tsongas (D-MA), Veasey (D-TX), Velazquez (D-NY), Walters (R-CA), Wasserman Schultz (D-FL), Watson Coleman (D-NJ), and Wilson (D-FL).