Power has been restored to three Baxter International plants in Puerto Rico, meaning production of saline solution and amino acids is increasing. But that doesn’t mean the shortages that have plagued the entire U.S. healthcare system are past.
The power grid remains unstable in some places and inventories have yet to be rebuilt, meaning drugmakers are expected to keep customers on allocations and hospitals need to carefully manage the supplies they have and will get in the meantime.
That is the assessment of FDA Commissioner Scott Gottlieb, who provided an update at the 100-day point since Hurricane Maria made landfall in Puerto Rico, taking out the island’s power grid and production for the roughly 50 drug production facilities on the island.
“All the other companies that manufacture products that were on our initial list of drugs that we considered critical and at risk of potential shortages—because the drugs were largely or entirely manufactured in Puerto Rico—are now on the power grid. Many of these companies report to us that their production is increasing,” Gottlieb said Thursday.
In an emailed message Friday, Baxter said, "All three of Baxter’s manufacturing facilities are connected to the electric grid. Reliable and stable electric power is key to our ongoing efforts to restoring sustainable manufacturing operations. All facilities will continue to have backup diesel generation in case of power interruptions, which still occur intermittently.
"We have in fact increased the amount of certain products available to customers thanks to increased production in Puerto Rico and the special importation products. Overall, we expect to return to more normal supply levels for products made in Puerto Rico in the coming weeks."
Hurricanes Maria and Irma battered the island in September, taking out power and communication networks and making many roads impassable. That left manufacturers to rely on generators but made it difficult to get fuel to plants. Because the devastation was so severe, many employees had to deal with their own personal disaster situations.
Many presentations of saline were already in short supply before the hurricanes took Baxter’s three saline and amino acid plants out of meaningful production. Baxter’s plants produce small volume presentations of sodium chloride. A shortage of amino acids, used to feed some patients intravenously, was exacerbated not only by the hurricane damage but because another supplier in December took a plant down for overdue maintenance.
The FDA has taken steps to get production restored in Puerto Rico and to get additional saline supplies to the U.S., asking to have the Baxter plants put at the front of the line to get power restored. It also has allowed some suppliers to ship saline to the U.S. from plants that were not FDA approved if they could show their products meet U.S. standards. But all of those steps take time and hospitals have continued to have to take extraordinary measures to make supplies last.
While Gottlieb Thursday was able to report “cautious progress,” he acknowledged “the production situation in Puerto Rico remains fragile” and shortages still exist despite the best efforts of the FDA.