92 Congressional Members Press FDA on Product Shortages

A 2/2 letter to FDA from 92 bipartisan members of the U.S. Senate and the House urges the agency to use all tools at its disposal to address the dire shortages of IV saline and other critical medical products caused by Hurricane Maria that devastated Puerto Rico’s medical product manufacturing industry. “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,” the letter says. “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.”

The letter follows a 2/1 update from FDA commissioner Scott Gottlieb that indicated the agency is working closely with companies that manufacture saline to limit and improve the shortage issues. He said the agency expects supplies of saline to increase over the next month, noting that having adequate supplies, especially during this severe flu season, is a critical matter of public health.

The lawmakers in their letter asked FDA:

1. What steps it has 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 it expect these products to become widely available?
4. Does it have the tools necessary to increase the nation’s supply of saline and other IV fluids?
5. What steps it is taking  to ensure manufacturers are creating contingency strategies to avoid future shortfalls? 
6. Is it 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?