Associate Commissioner Says Supply Chain at Risk in Every Industry FDA Regulates

Deeply embedded supply chain challenges, such as “just in time” manufacturing methodology and sole sourcing to maximize profit, are key drivers of low inventories and offshoring, said Mark Abdoo, associate commissioner of FDA’s Office for Global Policy and Strategy (OGPS) in a recent speech.

Addressing the International Bar Association World Life Sciences Conference earlier this month, Abdoo noted that “our overseas offices give us a front row seat to observe many elements buffeting the world’s supply chains of the products we regulate.”

“In the face of international strife and economic distortions,” he said, “these risks have resulted in real-world consequences affecting ... the availability of certain drug products.”

Abdoo also told the group the FDA relies on “strong domestic and international partnerships to achieve its public health mission,” explaining that “often, a single regulatory authority — even one with the resources of the FDA — may lack the tools to address such issues,” especially during health emergencies.

The FDA overseas offices — located in China, India, Belgium, Chile, Costa Rica and Mexico — serve as critical hubs to collect, analyze and transmit information back to the FDA headquarters to inform the agency’s decision-making. This information is not only used to inform longer-term regulatory policies, but also to cope with emergencies.

Related Topics