FDA keeping close watch on Puerto Rico’s medical manufacturing infrastructure

By: 
October 10, 2017

Add the medical product supply chain to the long list of victims of Hurricane Maria. Puerto Rico is home to approximately 70 medical device manufacturers, according to Business in Puerto Rico, as well as numerous suppliers to these OEMs. The island also produces a number of top-selling pharmaceuticals, some of which are critical to Americans in the territory and throughout the 50 states, FDA Commissioner Scott Gottlieb told a congressional panel last week. As of Friday, Oct. 6, some of the medical device facilities were “up and running again on generator power,” but none were operating at full capacity, reports the Minneapolis StarTribune.

Some of the world’s foremost medical device manufacturers, including Medtronic, Boston Scientific and Abbott, have operations on the island. FDA has a significant role to play in helping Puerto Rico recover its medical product manufacturing base, said Gottlieb in a statement posted on the FDA website. “These facilities are a key component of the island’s economic vigor. The pharmaceutical and biological drug products and medical devices produced on the island account for about 30 percent of Puerto Rico’s gross domestic product. Moreover, about 80 percent of the drug products manufactured on the island are consumed by U.S. citizens in Puerto Rico and across all fifty states. Securing this manufacturing base is vital to maintaining access to many important medical products,” wrote Gottlieb.

While some of the facilities sustained minor damage and are running on generator power, the possibility that the power grid could be crippled for months makes the situation tenuous, at best. “Most of the facilities that we know of, that have resumed production, maintain only partial operations,” noted Gottlieb. “New shortages could result from these disruptions and shortages that existed before the storms could potentially be extended.”

FDA is keeping a close watch on the most critical medical products, he added.

After Puerto Rico, Medtronic takes a hit in California

All of the Medtronic facilities in Puerto Rico suffered damage from Hurricane Maria. The medtech giant told the Minneapolis/St. Paul Business Journal that those facilities were all partially operational again but were limited by the use of diesel-powered backup generators. It expects manufacturing to gradually ramp up over the coming weeks.

Meanwhile, in Northern California, Medtronic was forced to evacuate four buildings in proximity to the wildfires ravaging the state’s wine country. “We are closely monitoring the wildfires in Santa Rosa and Sonoma County, and our first priority is the safety of our employees, many of whom are being evacuated,” spokesman Fernando Vivanco told the StarTribune. “We have initiated our business continuity plans and are accounting for and keeping in contact with employees in the area.”

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