The US pharmaceutical industry has always been unique from other industries, due in large part to the exclusivity granted by the US Patent and Trademark Office to encourage innovation. However, this exclusivity leaves the industry particularly vulnerable to supply disruptions, historically caused by issues such as quality concerns, trade interruptions, and raw ingredient shortages . The 2017 hurricane season brought to light a new concern for the already fragile pharmaceutical supply chain – climate change .
According to research by the Geophysical Fluid Dynamics Laboratory, anthropogenic warming (that is, warming caused by the actions of humans) is expected to lead to hurricanes that are 2-11% stronger than historical storms . The US Food and Drug Administration, the organization responsible for regulating the pharmaceutical industry in the United States, experienced this danger first hand in September of this year, when Hurricane Maria made landfall in Puerto Rico.
In the 1970s, pharmaceutical and medical device companies were attracted to Puerto Rico by tax incentives meant to enhance the island’s economy . Today, medical products account for 75% of Puerto Rico’s exports. By the time Maria had passed over Puerto Rico, she had left in her wake a path of destruction rarely before seen by the island. The electrical grid was effectively destroyed, forcing hospitals to perform operatations via flashlight. Equally affected by the destruction were the many pharmaceutical manufacturing facilities on the island, which (where still operational) had to begin relying on diesel-powered generators to continue production of life-saving or -sustaining drugs. One example is Mylan’s methotrexate, which treats childhood leukemia and is manufactured on the island. In addition to methotrexate, Dr. Scott Gottlieb, commissioner of the FDA, cited concerns about 40 drugs manufactured in Puerto Rico, 13 of which are “sole source” due to patent protection [4, 8].
With continued global population growth and the industrialization needed to support such growth, climate change will continue to be a concern for pharmaceutical manufacturers, whose operations are often located in vulnerable or developing markets where storm recovery may prove challenging. As the guiding organization behind such a critical industry for the health and safety of Americans, how can the FDA prepare the pharmaceutical industry for the continued impact of climate change on the health of the global supply chain?
In anticipation of the coming storm, the FDA worked closely with pharmaceutical manufacturers in Puerto Rico to implement hurricane preparedness plans, which included the increased production and exportation of finished goods inventory to mainland USA. After the arrival of Maria, Dr. Gottleib visited the San Juan office of the FDA to address any food or drug safety concerns originating due to flood waters or refrigeration interruptions [5, 6, 7]. However, these reactions were purely adaptive, helping the industry to cope with the effects of stronger storms rather than contribute to the mitigation of these storms entirely.
The FDA has a duty to American citizens to protect both the food and drug industries from the impacts of climate change. This is especially true given the reliance of these industries on biologically derived raw materials, which are threatened by the effects of climate change. There are a few ways the FDA can improve their reaction to climate change in the next few years. First, the FDA should consider regulation to prevent supply disruptions caused by manufacturing exclusivity. For example, the FDA should require secondary manufacturing locations be approved for single source drugs, which can be activated as needed. However, this creates complications surrounding the cost burden and who will need to bear it.
Secondly, and perhaps most importantly, the FDA must take a position on climate change mitigation. The FDA has a responsibility to the American public to address climate change and prevent the impacts it will have on the food and drug supply. A quick search of the FDA website for the term “climate change” yields no discussion of the risk factor or steps to address it . With events like Hurricane Maria are becoming more commonplace, the FDA should work with the rest of the US government to incentivize companies to reduce their contributions to climate change via fossil fuel emissions. Failing to do so creates an uncertain future regarding national healthcare.
This is far from a simple issue to address. As in many industries, questions surrounding climate change and the global economy are intertwined. A growing debate in the wake of Hurricane Maria is if drug manufacturers should continue to operate on the Caribbean island at all, given future storm risk. What will staying do to the supply chain and what will leaving do to the Puerto Rican economy? Is there even such a thing as a “risk free” manufacturing environment given the global impacts of climate change – or has climate change become a global health crisis? These are questions the brightest minds in healthcare must answer, and quickly.
 US Food and Drug Administration. Drug Shortages Database, https://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm, Accessed Nov 12, 2017.
 Princeton University Geophysical Fluid Dynamics Laboratory. “Global Warming and Hurricanes,” https://www.gfdl.noaa.gov/global-warming-and-hurricanes/ , Last revised Oct 26, 2017.
 Scott Greenberg and Gavin Ekins. “Tax Policy Helped Create Puerto Rico’s Fiscal Crisis,” https://taxfoundation.org/tax-policy-helped-create-puerto-rico-s-fiscal-crisis/, Published Jun 30, 2015.
 Katie Thomas and Sheila Kaplan. “Hurricane Damage in Puerto Rico Leads to Fears of Drug Shortages Nationwide,” https://www.nytimes.com/2017/10/04/health/puerto-rico-hurricane-maria-pharmaceutical-manufacturers.html, Published Oct 4, 2017.
 “Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s immediate steps to respond to Hurricane Maria and ongoing recovery efforts related to Hurricanes Harvey and Irma,” press release, Sep 22, 2017, on FDA website, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577112.htm
 Jade Scipioni. “Pfizer, Eli Lilly respond to reports of drug shortages from Puerto Rico damage,” http://www.foxbusiness.com/features/2017/09/29/pfizer-eli-lilly-respond-to-reports-drug-shortages-from-puerto-rico-damage.html, Published Sep 29, 2017.
 David Kroll. “FDA Works To Prevent Global Drug Shortages From Damage To Puerto Rico Factories,” https://www.forbes.com/sites/davidkroll/2017/09/26/fda-expands-role-to-prevent-puerto-rico-sourced-drug-shortages-after-hurricane-maria/#5f28aec43f5d, Published Sep 26, 2017.
 Adam Aton, “Hurricane Maria Takes a Toll on Global Medical Supplies,” https://www.scientificamerican.com/article/hurricane-maria-takes-a-toll-on-global-medical-supplies/, Published Oct 25, 2017.
 Anders Levermann. “Climate economics: Make supply chains climate-smart.” Nature 506, 27–29 (06 February 2014) http://www.nature.com/news/climate-economics-make-supply-chains-climate-smart-1.14636
 Google Search of US Food and Drug Administration Website. Conducted Nov 12, 2017. https://google2.fda.gov/search?q=climate+change&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&requiredfields=-archive%3AYes&output=xml_no_dtd&getfields=*
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