Without Funding, Supply Chain Disruption Planning Will Cease, CDRH’s Shuren Says

If CDRH doesn’t get $11.5 million from Congress this year to keep up its program to prevent medical device supply chain disruptions, the program will go dark next year, said center director Jeff Shuren on Tuesday during an Alliance for a Stronger FDA webinar focused on the budget.

Explained Shuren, during COVID, Congress allotted CDRH half the money it needed to build a program focused on supply chain shortages, which allowed the office to better react to ongoing shortages. But to be able to predict and prevent shortages, he said, CDRH needs the rest of the funding.

Shuren said CDRH has used those COVID-era capabilities to work with EPA on what the impact would be of removing the known carcinogen ethylene oxide (EtO) from manufacturing plants, where it’s long been used as a sterilization agent. The office also used the program to pick up problems with devices coming out of China. But the program can’t continue without more funding.

“Without those additional dollars, we’re going to be sunsetting those capabilities next year,” said Shuren. “Certainly if we ever run into another big health emergency like COVID, we will have serious problems if we don’t have those capabilities.”

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