FDA warns 'critical' drug shortages possible after Hurricane Maria battered Puerto Rico

(USA TODAY) -- The U.S. Food and Drug Administration is warning of possible "critical shortages" of key pharmaceuticals after Hurricane Maria brought Puerto Rico's drug manufacturing industry to a standstill.

The FDA said late Monday that 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 Tuesday morning.

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 Friday that Hurricane Maria had put the drug industry at serious risk of shortages.

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.

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.

Updates from pharmaceutical companies contacted by USA TODAY on Tuesday morning:

Eli Lilly: The Indianapolis-based company said Tuesday it expects "no supply risk to patients at this time" after its sites experienced "minimal damage" and advance work helped prevent shortages.

"We have multiple internal and external manufacturing sites in our global network that manufacture our products, reducing the risk of supply issues due to a natural disaster," Lilly spokeswoman Tamara Hull said in an email. "We have contingency plans in place and will implement those if needed."

AbbVie: The pharmaceutical spinoff of Abbott Laboratories said that its Puerto Rico sites are running on backup power and employees are "working diligently to restore normal operations."

The company, which employs about 1,200 people in Puerto Rico, said it had "managed our inventory to assure availability of medicines to patients" and expects "no patient impact."

Others: More updates to come as they become available.

© 2017 USATODAY.COM


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