Drug Shortages Feared in Aftermath of Hurricane Maria

In addition to addressing the humanitarian toll that Hurricane Maria has taken on the residents of Puerto Rico, an additional, long-term challenge in coping with the storm’s aftermath is the potential for drug shortages.
The Center for Biosimilars Staff
October 05, 2017
In addition to addressing the humanitarian toll that Hurricane Maria has taken on the residents of Puerto Rico, an additional, long-term challenge in coping with the storm’s aftermath is the potential for drug shortages.

According to a 2016 report, half of the world’s leading pharmaceutical companies operate in Puerto Rico, and 13 of the 20 top-selling drugs are manufactured there. With 80 FDA-approved manufacturing facilities, the island supplies critical medicines and devices, both to the rest of the United States and to 86 other countries.

Among the crucial products manufactured in Puerto Rico are Amgen’s pegfilgrastim (Neulasta) and etanercept (Enbrel), as well as AbbVie’s adalimumab (Humira). As no biosimilars are yet available for these treatments in the United States marketplace, patients have no alternatives to these branded products.

Also affected is methotrexate, a drug frequently used in the treatment of inflammatory conditions as well as some cancers. Methotrexate has been subject to previous shortages, and The New York Times reports that FDA officials are especially concerned about the supply of this product, which Mylan manufactures in Puerto Rico. The agency is reportedly maintaining a list of approximately 40 drugs about which it has supply concerns, 13 of which are only manufactured in Puerto Rico.

FDA Commissioner, Scott Gottlieb, MD, said in a statement this week that the agency is “working around the clock” to address potential “catastrophic” drug shortages resulting from the hurricane’s impacts on manufacturing facilities on the island. Gottlieb said that the agency worked closely with drug and device firms, during and after the storm, to determine the level of damage that facilities had sustained, and to assess whether facilities could continue to run on generator power.

Gottlieb highlighted the fact that the work to rebuild the pharmaceutical industry’s presence in Puerto Rico was not limited to addressing the short-term issue of drug shortages: “We need to ensure access to these critical treatments for the Americans who need them, but also recognize the important role that the medical product industry plays in helping Puerto Rico sustain its economy and help in its recovery,” he said. “The pharmaceutical industry in Puerto Rico is responsible for nearly 90,000 jobs, and the island will need them to recover and rebuild.”

While fears about an interrupted drug supply occupy many stakeholders, patients needing treatment in Puerto Rico’s hospitals have an even more acute set of concerns this week: NPR reports that approximately 75% of hospitals on the island are still relying on emergency generators for power, and temperatures in some hospitals had exceeded 108 degrees Fahrenheit. In hospitals that have experienced periods of power loss, some patients have had to be relocated into other, already crowded facilities, where patients face long waits for emergency care.

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