FDA Commissioner Scott Gottlieb, MD, said that the United States is likely to see shortages on certain drugs because after Hurricanes Irma and Maria knocked out power to the islands.
FDA Commissioner Scott Gottlieb, MD, said that the United States is likely to see shortages on certain drugs after Hurricanes Irma and Maria knocked out power to Puerto Rico.
At the same time, Gottlieb said the agency is working with Baxter and other manufacturers to mitigate the shortages.
Around 10% of drugs prescribed in the United States are manufactured in Puerto Rico, which faced a double whammy when Hurricane Irma knocked out power to much of the island in early September and then Hurricane Maira knocked out electricity across the island on September 20.
Only 16% of the power to the island has ben restored, according to a Reutersarticle.
“A lot of companies say they’re online, but they basically have one of five lines running at 20% or 80% or 50%,” Gottlieb told Reuters. “It’s unclear when they are going to be able to bring that up to full capacity.”
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FDA warned that around 40 drugs manufactured in Puerto Rico could face shortages, including treatments for cancer, rheumatoid arthritis and HIV. Merck & Co, Johnson and Johnson, Amgen, Bristol-Myers Squibb, Eli Lilly and Co., and other major manufacturers have facilities in Puerto Rico.
However, FDA has been working closely with Baxter and other companies “to reduce the risk of shortages of critically important drugs and to minimize impact on any existing shortages,” Gottlieb said in a statement.
For example, Baxter and FDA identified ways to prevent a significant shortfall of production of Baxter’s sodium chloride 0.9% injection bags from its Puerto Rico facility.
“While these products have been in shortage industry wide since 2014 and other manufacturers exist, the agency and Baxter recognized that further shortage of this product could potentially put US healthcare at risk. The FDA has worked closely with Baxter to find solutions to prevent additional shortages,” Gottlieb said.
FDA is helping manufacturers in Puerto Rico secure fuel and manufacturing supplies and is providing logistical support to move critical products onto and off the island.
“FDA is also expediting reviews and approvals of other dosage forms and generic versions of products as alternate sources of critical products,” Gottlieb said.
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