FDA Addresses Pharma Manufacturing in Puerto Rico in Wake of Hurricane Damage

By Patricia Van Arnum - DCAT Editorial Director

September 26, 2017

The US Food and Drug Administration’s (FDA’s) Commissioner Scott Gottlieb, MD, has released a statement on the FDA’s plans to help Puerto Rico recover its medical-product manufacturing base following damage from Hurricane Maria.

“The island is home to a substantial base of manufacturing for critical medical products that supply the entire world,” said Gottlieb in a statement. ”This industrial base is an important source of jobs and economic vitality for the island. It is a key to Puerto Rico’s economic recovery. The manufacturing facilities are also a pivotal source of critical medical products for the entire United States. Helping to bring these resources back in operation is an important goal of ours and of Puerto Rico’s.”

Gottlieb outlined the steps that the FDA has taken prior to and following the storm. “Leading up to the storm, our team of shortage experts worked to identify and coordinate with companies that have manufacturing facilities in Puerto Rico to assess the potential impacts on their facilities to avoid—whenever possible—shortages of critical medical products,” he said in his statement. “During and following the storm, we have worked with pharmaceutical and medical device firms to figure out whether manufacturing facilities were damaged, or if they were still operational and could continue to function on generator power.”

He added that “we have undertaken swift and extensive efforts to prevent or limit the loss or shortage of multiple drugs critical to American patients due to the challenges related to refrigeration, storage and transportation. The agency has been working closely – throughout the weekend and into today [Monday September 25, 2017] to relocate products in coordination with our federal and local government colleagues and pharmaceutical companies.”

The FDA, the Departments of Health and Human Services and Homeland Security as well as local agencies have helped with the following: clear debris to reach facilities; assess fuel needs to keep generators running; secure permissions to allow planes to land in Puerto Rico, and fly critical products to the continental US.

Gottlieb has directed FDA staff to create a hurricane shortages task force that will identify potential issues and solutions. The agency has broadened the mandate of its emergency operations team to take on the additional task of prioritizing efforts to address the potential for medical-product shortages.

The pharmaceutical industry in Puerto Rico is responsible for nearly 90,000 jobs, according to information from the FDA.

Several pharmaceutical companies provided updates on their manufacturing operations. Amgen said that its preliminary assessment is that the critical manufacturing areas in its facility in Juncos, Puerto Rico were not significantly impacted by this storm. The company said that no product nor in-process inventory has been lost, and consistent with the company's practices, the inventory maintained by the company and its global distribution network is sufficient to meet patient demand. Amgen has back-up generators powering the site and is working with hundreds of its staff onsite to return its operations in Puerto Rico to normal as quickly as possible.

AbbVie said that its facilities in Puerto Rico are running on independent power generation unit and are intact and operational, with teams working to restore normal operations. “AbbVie’s manufacturing network is designed to provide multiple and redundant channels of product supply, and we have managed our inventory to assure availability of medicines to patients,” said the company in a statement. “No patient impact is expected as a result of Hurricane Maria.”

Source: FDA, AbbVie and Amgen