FDA warns of Puerto Rico drug shortages

The US may soon be hit by drug shortages because of recovery delays in Puerto Rico, where a tenth of the nation's drugs are made.

The US Food and Drug Administration is warning the country may suffer drug shortages due to delays in restoring manufacturing operations in Puerto Rico, where 10 per cent of drugs prescribed in the United States are made.

Hurricane Maria slammed into the Caribbean island on September 20, knocking out electricity and causing widespread damage to homes and infrastructure.

Almost three weeks later, just 16 per cent of electricity service has been restored to the US territory.

Drug makers are working to get facilities fully online, but face an uncertain power supply and difficulty obtaining materials used in the manufacturing process.

"A lot of companies say they're online, but they basically have one of five lines running at 20 per cent or 80 per cent or 50 per cent," FDA Commissioner Scott Gottlieb told Reuters on Tuesday.

Asked when US hospitals and pharmacies might see shortages in the next few weeks as a result.

The FDA has warned of 40 drugs made in Puerto Rico that could face shortages, including treatments for cancer, rheumatoid arthritis and HIV, but has not named specific medicines.

Most major drug companies have manufacturing facilities on the island, including Merck & Co, Johnson and Johnson , Amgen Inc, Bristol-Myers Squibb Co, Eli Lilly and Co, Pfizer Inc, AstraZeneca and GSK

The FDA leader said he wants drug makers to provide the public with more information about the extent of the problems they are facing.

He said the plants were all relying on backup generators for electricity, some of which were not designed to operate for sustained periods of time.

Of the list of drugs being closely monitored by FDA, 14 medicines are sourced solely out of Puerto Rico, Gottlieb said.

He said the agency was working with drug makers to consider approving manufacturing sites in other countries, such as Mexico, Canada or Ireland, to alleviate possible shortages if companies have plants there.


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Source: AAP


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