The FDA has been helping dozens of U.S. drugmakers in Puerto Rico get power and supplies to their plants in the wake of the infrastructure disaster left by hurricanes Irma and Maria. But with a shortage of saline getting worse in the U.S., the FDA is moving three Baxter plants on the island to the front of the line.
FDA Commissioner Scott Gottlieb today said that state and federal authorities have been responsive to its request that a “subset of critical production facilities,” including those plants that manufacture IV saline bags, get priority in getting fuel for their generators and hooked back to the grid ahead of others.
“Unfortunately, most manufacturers are still relying on generator power, and even those that have returned to the electrical grid continue to face interruptions as the grid is rebuilt," Gottlieb said. "We’re hopeful that these companies manufacturing medically important products will see their power needs addressed on an accelerated basis.”
A shortage of some presentations of the medically essential saline solution has fettered hospital care since at least 2014. But the issue immediately got worse when hurricanes knocked down power lines and tore up roads in Puerto Rico, interrupting production and distribution from more than 40 U.S. plants on the island, including Baxter’s three producing saline.
The situation has grown even more desperate since then because B. Braun, one of the three major saline producers, announced it is halting production at a saline plant in December for delayed maintenance after other “unplanned interruptions” had already affected its available inventory. “The December shutdown will further strain our inventory levels,” it told customers in a letter.
The FDA has taken other steps to help hospitals get their hands on enough saline, like approving the temporary import of products from plants outside the U.S. that were not previously FDA approved. It expects those efforts to offer some relief in coming weeks.
“That said, this shortage will require a sustained effort by industry, the agency and other partners to return to production levels that adequately meet the needs of patients,” Gottlieb acknowledged.