The FDA and Climate Change:
The 2017 hurricane season gave us a terrifying view into the future that awaits us – extreme storms, unprecedented flooding, and mass devastation. One industry that was hit particularly hard by this year’s extreme weather events was the pharmaceutical industry. Even minor disruptions to the pharmaceutical supply chain can have far-reaching, detrimental effects due to the life-saving nature of these products and the lack of available substitutes in the event of a shortage . This paper will examine the steps the US Food and Drug Administration (FDA) is taking to help mitigate future risks to pharmaceutical supply chains as a result of natural disasters and extreme weather patterns.
When Hurricane Maria hit Puerto Rico in September 2017, it caused a major shock to the pharmaceutical supply chain. As a result of its attractive tax policies, Puerto Rico had become a haven for pharmaceutical manufacturing, and housed approximately 50 pharmaceutical manufacturing facilities . In the wake of the hurricane, companies such as Astra Zeneca and Eli Lilly stated that they were bracing for the possibility of months of downtime .
While this downtime is bad for each company’s bottom line, it is even more detrimental for human health. Approximately 8% of all medications taken in the US are produced in Puerto Rico, and following the storm, the FDA stated it was monitoring possible shortages of 30 different drugs, including 14 that have no substitutes . Baxter, a supplier of intravenous saline, was hit hard by the storm, and as a result, some US hospitals downstream in the supply chain reported trouble getting supplies they use to deliver drugs to patients .
The events in Puerto Rico offer a first glimpse of problems we will likely face in the future as climate change increases the frequency of extreme weather patterns, posing a threat to the pharmaceutical supply chains. This looming risk demonstrates a clear need for the FDA to intervene now to mitigate future probable disruptions to the supply chain.
Short term management:
After Hurricane Maria, in response to the mass supply chain disruptions, the FDA created a Hurricane Drug Shortage Task Force . The goal of this task force is to identify potential problems and devise solutions to deal with possible drug shortages resulting from extreme weather [5, 6]. The exact nature of these solutions has yet to be articulated, but given that this committee was announced less than two months ago, I am optimistic that we will hear more specific details in the near future.
Medium term management:
Hurricane Maria catalyzed immediate action from the FDA regarding drug shortages, but the FDA had been grappling with the issue of pharmaceutical supply chain interruption for many years before Hurricane Maria. In 2012, the FDA issued the FDA Safety and Innovation Act (FDASIA), which, among other things, gave the FDA more visibility into the pharmaceutical supply chain in an attempt to protect against future shortages [7, 8]. While this act was largely put into place to guard against human errors that can lead to shortages, it also protects against factors outside of a manufacturer’s control, such as natural disasters . Moving forward, I suspect we will see this act used more and more to respond to or anticipate supply chain disruptions caused by natural disasters.
Additional steps I recommend:
Given that we are likely to see more extreme weather events moving forward, I would recommend that the FDA enact policies to force companies to geographically diversify the locations of their production facilities, particularly for products that are life-saving and have no substitutes. These life-saving products should not be produced in a single location – there should be at least two production facilities located in two different geographies in order to hedge against the risk of environmental disruptions to the supply chain.
Additionally, I would suggest that the FDA mandate that pharmaceutical companies carry heavy inventory at all times in order to protect against the possibility of disruptions to the supply chain. In order to lessen the financial impact of carrying inventory on the manufacturer, the additional inventory could be spread out over various stages of the supply chain including the production center, wholesale distribution centers, and end users.
- Can and should the FDA require pharma companies to keep heavy inventory in order to protect against possibly supply chain shortages in the future?
- Should there be a reward for pharmaceutical companies that willingly spread out their production over multiple geographies in order to mitigate environmental risks to the supply chain? Could this reward come in the form of a patent life extension?
 Aton, Adam. “Hurricane Maria Takes a Toll on Global Medical Supplies.” Scientific American. N.p., 25 Oct. 2017. Web. 14 Nov. 2017. <http://www.scientificamerican.com/article/hurricane-maria-takes-a-toll-on-global-medical-supplies/>.
 Isidore, Chris, Tal Kopan, and Julia Horowitz. “Closed Puerto Rico Factories Are the Sole Source of Some Critical Drugs.”CNNMoney. Cable News Network, 29 Sept. 2017. Web. 14 Nov. 2017. <http://money.cnn.com/2017/09/29/news/companies/puerto-rico-drug-makers/index.html>.
 Bomey, Nathan. “Hurricane Maria Halts Crucial Drug Manufacturing in Puerto Rico, May Spur Shortages.” USA Today. Gannett Satellite Information Network, 22 Sept. 2017. Web. 14 Nov. 2017. <https://www.usatoday.com/story/money/2017/09/22/hurricane-maria-pharmaceutical-industry-puerto-rico/692752001/>.
 McGinley, Laurie. “Hospitals Scramble to Avert Saline Shortage in Wake of Puerto Rico Disaster.” The Washington Post. WP Company, 11 Oct. 2017. Web. 14 Nov. 2017. <https://www.washingtonpost.com/news/to-your-health/wp/2017/10/09/hospitals-scramble-to-avert-saline-shortage-in-wake-of-puerto-rico-disaster/?utm_term=.bb64b5004fc4>.
 Kroll, David. “FDA Works To Prevent Global Drug Shortages From Damage To Puerto Rico Factories.” Forbes. Forbes Magazine, 26 Sept. 2017. Web. 14 Nov. 2017. <https://www.forbes.com/sites/davidkroll/2017/09/26/fda-expands-role-to-prevent-puerto-rico-sourced-drug-shortages-after-hurricane-maria/#6aaba90f3f5d>.
 FDA. Press Announcements – Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA Actions to Bring Relief to Citizens of Puerto Rico; to Help the Island Recover Its Considerable and Economically Vital Medical Product Manufacturing Base; and to Prevent Critical Shortages of Life-saving Drugs Made in Puerto Rico. U S Food and Drug Administration Home Page. Office of the Commissioner, 25 Sept. 2017. Web. 14 Nov. 2017. <https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577338.htm>.
 “Fact Sheet: Drug Products in Shortage in the United States.” U S Food and Drug Administration Home Page. Office of the Commissioner, 29 Jan. 2016. Web. 14 Nov. 2017. <https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm313121.htm>.
 Strategic Plan for Preventing and Mitigating Drug Shortages. Rep. Food and Drug Administration, Oct. 2013. Web. 14 Nov. 2017. <https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM372566.pdf>.