FDA warns of drug shortages
‘Critical’ situation for key pharmaceuticals
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Patients could experience “critical shortages” of key pharmaceuticals, the U.S. Food and Drug Administration is warning after Hurricane Maria brought Puerto Rico’s drug manufacturing industry to a standstill.
The FDA said late Monday it is taking active measures to help redirect production and preserve existing treatments to avoid a ballooning health crisis from Maria’s destruction.
The agency did not identify any specific medications that could be at risk of a shortfall, and a spokesperson was not immediately available to provide details.
But there are “several” cases where “we may soon face critical shortages if we don’t find a path for removal or ways to get production back up and running,” FDA Commissioner Scott Gottlieb said in a statement.
USA TODAY reported recently that Hurricane Maria had put the drug industry at serious risk of shortages.
“Some companies are beginning to move product off of the island, and they’ve been communicating with the FDA about that and what potential challenges and limiting factors they see ahead,” said Nicolette Louissaint, president of Healthcare Ready, a non-profit group that addresses emergency supply chain crises during the hurricane season. “This situation is changing almost day by day.”
Drugs made on the island include AstraZeneca’s cholesterol treatment Crestor, Abbvie arthritis drug Humira and Johnson & Johnson-owned HIV drug Prezista. Those three companies have said supplies of their drugs are in good shape.
But the catastrophic storm wiped out electricity for the entire island, devastated telecommunications and made travel nearly impossible for many employees of the island’s nearly 50 pharmaceutical factories.
Complicating any efforts to restore the drug industry to full strength in Puerto Rico is the island’s financial crisis, which triggered the equivalent of bankruptcy earlier this year.
With backup power and an insufficient workforce, most, if not all, plants effectively halted production.
Louissaint said that transporting generator fuel to drug factories is the most challenging hurdle right now.
“There is fuel available,” she said. But “because of road damage and infrastructure damage, it is a little harder to get fuel where it needs to go.”
Many executives are using satellite phones to communicate since about 94% of cellphones still are not working, she said.
Pharmaceuticals represented
72% of Puerto Rico’s 2016 exports, valued at $14.5 billion, according to the U.S. Bureau of Labor Statistics.
The sector, which grew for years on the strength of tax breaks that were phased out in
2006, employs about 90,000 workers.
The island accounted for 25% of total U.S. pharmaceutical exports.
The FDA said it conducted preparatory work in coordination with drug companies ahead of Maria to protect pharmaceutical manufacturing capacity and preserve key treatments. Gottlieb said Monday he ordered the creation of a new task force to address hurricane-related shortages of drugs and medical devices.
“The agency has been working closely ... to relocate products in coordination with our federal and local government colleagues and pharmaceutical companies,” Gottlieb said.
Puerto Rico’s pharma industry will be slow to recover from storm