The FDA and drugmakers are taking steps to prevent global shortages of critical drugs after Hurricane Maria devastated Puerto Rico, an island that manufactures seven of the top 10 medicines sold worldwide. The FDA commissioner said his agency has about 40 drugs that could be in short supply, 13 of which are made only in Puerto Rico. These medicines include cancer and HIV drugs, immunosuppressants used by transplant patients, and vital diabetes devices.


The Situation
Twelve of the top 20 global pharmaceutical and biotechnology companies have manufacturing facilities on hurricane-ravaged Puerto Rico. In 2016, Puerto Rico was the top U.S. exporter of medical products making up 25% of the U.S. total which is more than the next two top places combined. The life science industry accounts for about 75% of Puerto Rico’s exports and employs about 90,000 people there at 80 different plants (50 pharmaceutical and 30 medical device).


The week Hurricane Maria hit was supposed to have been Puerto Rico Bioscience Innovation Week, an annual celebration of the U.S. territory's prominence in pharmaceutical, biotechnology and medical device manufacturing. However, Hurricane Maria made landfall as a powerful Category 4 storm with winds of 155 mph on Sept. 20, 2017. Dr. Scott Gottlieb, the FDA commissioner, arrived on Puerto Rico nine days later to survey the situation and talk with pharmaceutical executives on the island.


What’s Next?
Dr. Gottlieb said it's important that the plants that make drugs and medical devices resume normal operations soon, not just to ensure patients nationwide continue to have access to life-saving medicines, but also for Puerto Rico's economic health. In the meantime, steps are being taken to mitigate challenges related to refrigeration, storage and transportation of medicines on the island. A top priority was to ensure generators at pharmaceutical plants are maintained until power is restored. The good news is that many of the major factories suffered little damage, and most can operate to some degree on generator power. The FDA's concern is making sure that those plants continue to get the fuel they need, supplies to produce the drugs, and the means to transport the products off the island.


Bristol-Myers, Lilly and Amgen stated they have adequate product inventory and there are not currently any shortages for their customers. They all said their major concern is the welfare of their Puerto Rican employees. Pfizer, Eli Lilly and Baxter had similar statements relaying that their primary concerns are for their employees but also that they all had strategies in advance to relocate product and ensure healthy supplies. On the other hand, Dr. Gottlieb revealed that the agency is "aware of several other instances where we may soon face critical shortages if we don’t find a path for removal or ways to get production back up and running." The situation seems to be improving but the danger isn’t over yet.


In the wake of Hurricane Maria, only time will tell if Puerto Rico will remain as attractive for pharma and medical device companies. Tax advantages and a workforce experienced in pharmaceuticals were major benefits of having a plant on Puerto Rico, but will there be long term challenges as the island tries to rebuild?


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