FDA Works to Get Pharma Up and Running in Puerto Rico

FDA is ramping up efforts to help biopharma manufacturers that produce critical therapies in hurricane-devastated Puerto Rico to get on the power grid and back to full production. Not only is such action critical for preventing shortages and access problems to critical medicines, but it is vital for Puerto Rico’s economic recovery.

According to an economic analysis documenting the important role that medical product manufacturing plays in the island’s economy, FDA is closely monitoring supplies of some 30 drugs and 10 biologics that do not have clear therapeutic alternatives and are made primarily or exclusively on the island. These include immunosuppressive and anti-neoplastics for cancer, HIV medications, IV fluids and nutritional products, cardiovascular drugs, anti-depressants, and blood fraction products.

In addition, FDA is tracking about 90 medical devices that could face shortage situations, including 50 devices that may be life-supporting and made by only one company. These include glucose monitors, cardiac pacemakers, and blood collection systems.

FDA Commissioner Scott Gottlieb said he plans to return to Puerto Rico to further assess the prospect of getting key biopharma facilities stood up and connected to a rebuilt electrical grid. FDA is working with the Department of Homeland Security, Gottlieb explained on November 6 in a keynote speech at the Fall Technical Conference sponsored by the Association for Accessible Medicines in Rockville, MD. The aim is to identify a small subset of firms where there is a critical need to get production up and running to avoid shortages of critical drugs.

The economic analysis shows that drug and medical products firms employ 90,000 people and provide wages that total nearly $800 million in Puerto Rico. More than $40 billion in pharmaceutical products are made on the island, and federal and local officials recognize that it is crucial to stabilize this manufacturing sector to support Puerto Rico’s long-term recovery. While most pharma companies are in partial production using generators, few are operating at 100% capacity. FDA has been working to help drug and device companies obtain fuel for generators to continue operations.