FDA concerned about possible drug shortages in wake of devastation in Puerto Rico

The FDA said it is concerned that disruption of drug manufacturing in Puerto Rico in the wake of the devastation left by Hurricane Maria could lead to critical shortages of some drugs.

Scott Gottlieb, M.D., the FDA commissioner, recently arrived in the country to meet with pharmaceutical execs and assess the situation. The FDA has a list of 40 drugs Gottlieb told USA Today the agency is concerned could run short. Of those, 13 are only produced in Puerto Rico.

“These are critical medicines,” he told the newspaper. “These are not drugs for which there are therapeutic substitutes.”

Pharmaceuticals represent 72% of Puerto Rico's 2016 exports, which are valued at $14.5 billion, according to the U.S. Bureau of Labor Statistics. Puerto Rico makes up 25% of total U.S. pharmaceutical exports.

There are 50 pharmaceutical plants on the island. Most facilities have been operating with backup power and limited employees. Many workers and their families are still recovering from the hurricane that left the majority of Puerto Rico without electricity. Complete restoration of power there may take up to six months.

"That manufacturing base is critical to long-term manufacturing success of the island, and also getting people back to work," Gottlieb said.

AbbVie and Amgen told Fierce last week that their plants were running on backup generators and that critical operations at the facilities were not significantly impacted by the storm. 

Eli Lilly, AstraZeneca, and Bristol-Myers also have operations in Puerto Rico and reported their plants are operational.

The FDA's current focus is to make sure the manufacturing sites get fuel for their generators and the supplies needed to produce the drugs.

"We think we're getting ahead of it," Gottlieb said. ”The situation has been improving a lot since last week."