FDA Updates Drug Manufacturing Situation in Puerto Rico

The US Food and Drug Administration (FDA) has updated the agency’s efforts in supporting pharmaceutical manufacturing in Puerto Rico following Hurricanes Irma and Maria. This follows an earlier update from October 2017 provided by FDA Commissioner Scott Gottlieb, MD.

The FDA said it is currently monitoring approximately 90 products (approximately 50 medical devices, 30 drug products, and 10 biological devices/biologics) to help mitigate potential shortage situations.

“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 Gottlieb in an agency statement. “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.”

The FDA says it continues 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 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. These efforts includes working to ensure facilities have access to resources, such as 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.

In addition to the agency’s update, the FDA released an economic analysis that highlights the role that medical-product manufacturing plays in the Puerto Rican economy and its importance in supplying the US with products. The assessment looked at the industry’s contribution to the island’s gross domestic product (GDP), employment, and wages and the export base from Puerto Rico to the mainland of the US.

The report noted that approximately 30% 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% of Puerto Rico’s manufacturing employees are employed by manufacturers of medical products, which include drugs, biologics, and devices, and residents employed in the drug and medical-device industries collectively earn approximately $800 million in wages annually.

In terms of manufacturing, Puerto Rico produces more pharmaceuticals for the US ($40 billion in value) than any single state of the 50 states or any single foreign country, according to the report. The next largest producer of pharmaceuticals to the US was Ireland with $20 billion in annual pharmaceutical exports to the US. Within the US, the next largest producers other than Puerto Rico to the US are Indiana and California. Puerto Rico produces more pharmaceuticals than both of these states combined.

Additionally, approximately 8% of pharmaceutical expenditures in the US are for products manufactured in Puerto Rico. According to the National Drug Code Directory, there are more than 1,000 individual drug products that are registered to be manufactured in Puerto Rico, of which several hundred of these drugs are considered by the FDA to be medically important, according to the FDA report. Puerto Rico manufactures 30 drug products and approximately 10 biological devices/biologics that are of critical importance because Puerto Rico is a primary or sole manufacturing site and these drugs do not have clear therapeutic alternatives, according to the report. FDA said that all 40 of these products are being carefully monitored by the FDA Drug Shortage Teams; 14 of these drugs are sourced only in Puerto Rico.

Source: FDA

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