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US FDA's Gottlieb Warns Congress Of Shortages, Potential Job Losses In Puerto Rico

 
• By Sue Darcey

Medical-product manufacturers in Puerto Rico took a major hit from Hurricane Maria, but some are slowly getting back up to speed as portions of the island's electrical grid go back online and additional generator power is deployed by device and drug companies, FDA Commissioner Scott Gottlieb told a US congressional panel Tuesday. But he warned that some facilities are "'sole-source" providers of devices and drugs, and that some longer-term government support may be needed to prevent future product losses.

Puerto Rico Political Map

Because Puerto Rico is a "substantial base of medical product manufacturing," FDA has been working hard with other federal agencies and the governor of the US territory to restore power at device and drug facilities on the island to ensure their ability to manufacture needed devices and drugs, following the devastation of Hurricane Maria, US FDA Commissioner Scott Gottlieb told a congressional oversight panel Oct. 24.

"Approximately 9,000 medical product firms in the path of the storms [at all hurricane sites] were identified for follow-up by FDA; the agency has reached 60% of those firms and...

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More from Latin America

Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

China Strikes Back After Trump Ups Tariffs; Administration Further Delays Tariffs On Canada And Mexico

 
• By Brian Bossetta

In response to the Trump administration increasing its tariffs on imports from China, Beijing announced a ban on gene sequencers from US biotech firm Illumina, signaling a full-blown trade war could be in the making. Trump also pushed the deadline for implementing tariffs on Canada and Mexico back by another month.

PathAI Enters South American Market Partnering With Integrated Healthcare Network Rede D’or

 
• By Natasha Barrow

PathAI, a Boston-based AI-pathology startup backed by $355m, partners with Brazil’s largest integrated healthcare network to support diagnosis and treatment of cancer patients using its AISight image management system.

More from Geography

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

Health Literacy Issues Cost Major Economies $303B Per Year, Recent Study Shows

 
• By David Ridley

By addressing disparities in health literacy, particularly in the areas of oral care, bone health, nutrition and air pollution, the consumer health industry can “save lives and billions in healthcare costs, boosting productivity and increasing GDP,” says a new report from Haleon and Economist Impact.