Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA actions to bring relief to citizens of Puerto Rico; to help the island recover its considerable and economically vital medical product manufacturing base

Last week (week of September 18), I provided an update on the FDA’s initial efforts to respond to the impact of Hurricane Maria.  The hurricane’s destruction was just as bad, if not worse, than predicted.  Adding to the damage left by Hurricane Irma, tens of thousands of people have lost their homes, electricity, and running water — access to basic infrastructure has been substantially disrupted for many citizens of Puerto Rico and the U.S. Virgin Islands.

News coverage has touched on an issue about which we at FDA are very concerned and we are working around the clock to address – the potential for shortages of critical life-saving and life-sustaining drugs needed by patients on and off the island.

The medical product industry has a large presence in Puerto Rico, with dozens of drug and device manufacturing facilities that are responsible for the production of products – like cancer drugs, immunosuppressants used by transplant patients and devices needed for people with diabetes.  These are products that are used daily in hospitals, outpatient clinics and homes. 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.  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.

Since Friday, 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 – to relocate products in coordination with our federal and local government colleagues and pharmaceutical companies.  And while our work is not done, I am extremely thankful to all those at the FDA, the Departments of Health and Human Services and Homeland Security (DHS) as well as local agencies for their commitment to finding a solution that would help avoid catastrophic drug shortages.  This critical work included clearing debris to reach facilities; assessing fuel needs to keep generators running; and securing permissions to allow planes to land in Puerto Rico and fly critical products to the continental United States.

This work is not instead of lifesaving measures to evacuate, relocate and rescue the people of Puerto Rico. Rather it is being done in parallel – and is also of lifesaving importance to patients who rely on these critical medical products.  These efforts are also important to Puerto Rico’s economic recovery.

In the face of a natural disaster of this proportion, it is an evolving landscape and so we will continue to stay on top of the situation.  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.  That is why I have directed FDA staff to create a hurricane shortages task force that will identify potential issues and creative solutions.  We have broadened the mandate of our emergency operations team to take on the additional task of prioritizing efforts to address the potential for medical product shortages.

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 pharmaceutical industry in Puerto Rico is responsible for nearly 90,000 jobs, and the island will need them to recover and rebuild.

This is a catastrophic event unlike many the United States has faced. At the FDA we are pushing beyond our normal processes to support the relief efforts in Puerto Rico – whether it’s working to prevent shortages of life-saving therapeutics, helping to coordinate plane landing rights between DHS and pharmaceutical companies, ensuring ample blood supply or helping facilitate access to resources on the ground that our fellow citizens will need in their recovery efforts. We stand ready to use all our resources to help in these missions.

REFERENCE:  FDA Statement; FDA website; 25 SEP 2017

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