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FDA: Puerto Rico Faces ‘Critical’ Drug Shortages After Hurricane Maria Devastation

September 26, 2017, 4:00 PM UTC

The damage caused by Hurricane Maria has crippled Puerto Rico’s pharmaceutical industry, which could lead to critical shortages of certain drugs and medical devices, the U.S. Food and Drug Administration (FDA) said in a warning issued late Monday.

“We are aware of several other instances 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. “This is both a short- and long-term issue. We need to ensure access to these critical treatments for the Americans who need them, but also recognize the important role that the medical product industry plays in helping Puerto Rico sustain its economy and help in its recovery.”

The FDA said it is working with other agencies to restart the pharmaceutical industry in Puerto Rico to avoid a drug shortage. Since Friday, the FDA has been working to limit the loss of drugs “critical to American patients” due to a lack of refrigeration, storage and transportation, according to the agency.

Even before Hurricane Maria hit Puerto Rico, a team of shortage experts worked with companies that have drug manufacturing facilities in Puerto Rico to assess the potential impacts on their facilities to avoid shortages of critical medical products, the FDA said.

Now officials are working to assess the damage and pinpoint which drug manufacturing facilities could still operate on generator power. Hurricane Maria knocked out power to the entire island and took most of its telecommunications network offline. It could take months for all Puerto Ricans to get power. In the days following the hurricane, thousands of Puerto Ricans have been searching for ways to find phone service or Wi-Fi to get in contact with loved ones.

Gottlieb also announced he is creating a new task force to handle hurricane-related shortages of drugs and medical devices.

The drug industry has a large presence in Puerto Rico with dozens of drug and device manufacturers operating on the island, including Abbott, Baxter, Merck, Novartis, and Pfizer thanks to a now expired federal tax incentive Section 936 that encouraged drug companies to move there.

The industry is critically important to Puerto Rico’s economic recovery; it’s responsible for nearly 90,000 jobs on the island. About a quarter of all pharmaceutical drugs exported from the U.S. are made in Puerto Rico.

Puerto Rico’s drug manufacturing industry is also an essential supplier of pharmaceuticals and medical devices that thousands of U.S. hospitals and outpatient clinics use daily, including cancer drugs, immunosuppressants used by transplant patients, and devices needed for people with diabetes.