(Reuters)—The head of the U.S. Food and Drug Administration said the agency was working with several pharmaceutical and medical device companies in Puerto Rico to prevent shortages of medical products in the U.S. as it joins a massive effort to help rebuild the island that was ravaged by Hurricane Maria.1
Drugmakers are working to get facilities fully online after the storm slammed into the Caribbean island on Sept. 20, knocking out electricity and causing widespread damage to homes and infrastructure.
FDA Commissioner Scott Gottlieb said the agency has been monitoring more than 40 drug products in Puerto Rico, where 10% of the drugs prescribed in the U.S. are made.
The agency is also working closely with about 10 medical device makers to prevent shortages, particularly of blood-related medical devices, in the U.S.
Gottlieb said last week that the United States may face a small number of drug shortages due to delays in restoring manufacturing operations in the island.
There are currently more than 50 medical device-making plants in Puerto Rico, employing about 18,000 people.
The regulator is taking steps to mitigate shortages by importing devices from outside the U.S. or allowing manufacturers to shift production to alternative sites, the FDA said.
- U.S. Food and Drug Administration. News release: Statement by FDA Commissioner Scott Gottlieb, M.D. on medical device manufacturing recovery in Puerto Rico. 2017 Oct 20.