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FDA In Brief: FDA analysis reinforces the important role of medical product manufacturing to Puerto Rico’s economic vitality and the island’s jobs recovery

For Immediate Release: Nov. 6, 2017

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Media Inquiries

 Jennifer Corbett Dooren
 301-796-2983

"Our economic analysis underscores the important role that medical product manufacturing plays to the economic vitality of Puerto Rico and the island's long-term success. It's incumbent upon the FDA, working with federal and Puerto Rican authorities, to support the stabilization of this manufacturing sector as a way to help Puerto Rico secure its recovery. For example, prior to the devastation brought by Hurricane Maria, the medical product manufacturing sector provided, on average, approximately $800 million in local wages over a 12-month period, according to our analysis. This manufacturing industry is a key part of the island’s manufacturing base and is supported by a highly skilled workforce. As part of our solidarity with our fellow citizens in Puerto Rico, the FDA is committed to doing our part to support the restoration of this manufacturing base, both as a component of our vital public health mission and as part of our role in assisting with the island’s long-term recovery," said FDA Commissioner Scott Gottlieb, M.D. "As part of these efforts, the FDA has been working on a case-by-case basis with federal and local government partners to provide logistical support and help drug and device companies obtain fuel to enable them to continue operations. Our next priority is to help ensure manufacturers get back to stable production as soon as possible to ensure supply of critical products to patients across the United States. Our experts will be working closely with local and federal partners to prioritize a small subset of critical facilities – plants that manufacture medically important products that are sourced primarily or only in Puerto Rico – for consideration for earlier access to the rebuilt electrical grid. Most facilities can only engage in partial production on generators. Over time, and for a subset of facilities, our work to avert shortages might entail helping them get back closer to full production. The FDA remains fully committed to Puerto Rico’s long-term recovery."

Today, the FDA released an economic analysis that highlights the important role that medical product manufacturing plays in the Puerto Rican economy and its ability to meet the medical needs of Americans. The assessment looked at the industry’s contribution to the island’s Gross Domestic Product (GDP), employment and wages; as well as the potential for nationwide shortages of critical medicines and devices. Some of the key findings include:

  • Approximately 30 percent of Puerto Rico’s GDP in 2016 was driven by pharmaceuticals and medical devices, and these product segments were two of Puerto Rico’s largest exports.
  • Approximately 30 percent of Puerto Rico’s manufacturing employees are employed by manufacturers of medical products, which include drugs, biologics and devices.
  • Puerto Rico produces more pharmaceuticals for the U.S. ($40 billion in value) than any of the 50 states or any single foreign country.
  • The FDA is currently monitoring approximately 90 products to help mitigate potential shortage situations (approximately 50 medical devices, 30 drug products and 10 biological devices/biologics).

The FDA remains dedicated to supporting the U.S. response to the devastating hurricanes. We continue to work closely with medical product companies and federal and local government partners to support manufacturing recovery. At this time, the agency is prioritizing efforts in Puerto Rico that focus on preventing shortages of life-saving medical products, and restoring production in these facilities to help avert shortages, strengthen the local economy and support the people who rely on these jobs. This includes working to ensure facilities have access to resources, like fuel for generators, medical-grade gases and other supplies, as well as helping to triage and identify solutions to address new issues as they emerge. We will continue to communicate with the public as we have more information to share.

For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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