FDA head Gottlieb says hurricane damage in Puerto Rico “bad, if not worse” than predicted

The impact of Hurricane Maria on the island of Puerto Rico, including its substantial medical device manufacturing hub, is “just as bad, if not worse, than predicted,” FDA Commissioner Dr. Scott Gottlieb said in a statement released yesterday.

Many companies are rushing to assess damages to their facilities after the storm, with industry groups like AdvaMed and the FDA undertaking efforts to help begin the process of recovery for not only the production facilities on the island, but the people and infrastructure as well.

At AdvaMed’s Medtech conference today, Gottlieb said that the FDA has been actively engaged in the relief effort for all the damage done by the recent hurricanes, with a specific focus on Maria.

“Over the past week we’ve been especially active with the events unfolding in Puerto Rico. As you know, FDA has a lot of agency personnel on the island. Puerto Rico has long been home to many manufacturing sites of FDA regulated products, including medical devices. The island’s medical product manufacturing base is an important part of its economic foundation, and that industrial base has been a key part in the island’s ongoing economic recovery before this devastating storm,” Gottlieb told the crowd at the MedTech Conference.

Gottlieb said that the FDA is doing everything it can to support both its own personnel and citizens on the island, and that he is planning a personal trip to the island alongside colleagues from the Department of Homeland Security to continue to support such efforts.

AdvaMed chair and CVRx CEO Nadim Yared said the industry group was also working on addressing the issue in Puerto Rico.

“We all watched with alarm and sadness as the Texas gulf coast and my beautiful state of Florida and Puerto Rico and the Caribbeans were all battered by these storms, leaving widespread suffering, loss and destruction in their wake. As a resident of Florida I can tell you there’s nothing to compare to the anxiety and desperation when you are in the path of such a massive, massive force of nature. Our deepest sympathy goes to all those who are feeling the impact of the disaster,” Yared said in a presentation at the MedTech Conference.

Yared said that AdvaMed has partnered with AmeriCares, a health focused humanitarian organization, offering a 2-to-1 donation rate for individuals who ant to donate to the hurricane-affected regions.

Integra LifeSciences (NSDQ:IART), who has facilities on the island, said that its manufacturing facilities in Añasco, Puerto Rico “sustained relatively minor damage from the impact of Hurricane Maria,” and added that a team was on-site to oversee repairs.

The extent of damage to the infrastructure and the impact that will have on the business is less certain, Integra said, though its focus remains on supporting its employees and their families.

The company said it expects to see manufacturing restart in the “next few weeks,” with a gradual ramp in production until operations are restored, and that its inventory levels are “sufficient to mitigate significant sales disruptions,” according to a press release.

Many medtech companies on the island are focused on getting a basic head count of their employees, according to a Star Tribune report.

“Right now, everything is largely about meeting basic human needs. It’s really bad. Communications are almost nonexistant. What the companies are all focused on now is finding their employees, connecting with their employees and communities, and just trying to get a handle on where people are,” Medical Alley Association CEO Shaye Mandle said, according to the paper.

At least 10 deaths have been reported as due ot the storm so far, and the power grid may be inoperable for months, the Star Tribune reported.

The combination of hurricanes Harvey, Irma and Maria are expected to have at least a net 1% impact on US med device revenue for the 3rd quarter, according to a Barclay’s note to investors from analyst Matt Taylor.

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