Califf calls for mandatory reporting of device shortages

Robert Califf, commissioner of the US Food and Drug Administration (FDA), called for greater FDA authorities to better monitor medical device shortages, including mandatory reporting from manufacturers. He also said that greater attention should be paid to onshoring the production of medical devices in the US.

Califf made these calls at during an Alliance for a Stronger FDA webinar on Friday, where he discussed supply chain resiliency and his priorities for 2025.

Esther Krofah, an Alliance for a Stronger FDA Board Member and Executive Director of FasterCures, asked Califf how the agency balances national security interests with supply chain resiliency.

Califf said that more work is needed to achieve this balance and that the nation’s “adversarial relationship with China” has not helped to bolster supply chain resiliency.

Califf said he is concerned that China is such a large suppler of active pharmaceutical ingredients (APIs) to the US. “To be blunt about the supply chain, I don’t think we have balanced it, I think we are in serious jeopardy right now with almost 100% of our key starting materials coming from China.”

The commissioner said there is a real need for onshoring the manufacture of drugs and medical devices in the US. “There has been a lot of attention paid to drugs but not devices,” he said, noting that there is only one manufacturer of syringes in the US.

In response, Krofah said that Califf’s statement signaled a call to action and asked whether FDA needs new authorities from Congress to bolster the US health care product supply chain.

Califf said that “it seems like something bad has to happen before Congress gives us new authorities” and that one way to bolster resilience would be to require medical device manufacturers to report potential shortages, “We have hundreds of drug shortages, and on the drug side you have to tell us if you’re experiencing a shortage, but we don’t have this on the device side. It is kind of remarkable, isn’t it?” He added that Congress should mandate this authority to FDA so that “patients do not have to suffer because they can’t get devices.”

Currently, medical device manufacturers have the option of reporting potential device shortages. The former head of FDA’s device center, Jeffery Shuren, made similar calls to pass legislation to prevent potential medical device shortage before a public health emergency can be declared. (RELATED: Shuren: FDA needs new authorities to prevent device shortages beyond public health emergencies, Regulatory Focus 2 February 2023)

These attempts received pushback from the medical device industry because of the perceived administrative burdens on companies.

Califf was also asked to address his budget priorities. He said that “far and above the most pressing issue is the Human Foods Program. We want the FDA to have the resources they need to do the work they need.”

His second priority is to implement the new organization of the Office of Regulatory Affairs, which he called the “largest reorganization in ORA’s history … This is where more funding will make a huge difference. He said that FDA needs to be fully funded in this area to be able to inspect all the facilities in its remit, noting that FDA has more than one million firms in its inspectional inventory.

Califf calls for mandatory reporting of device shortages

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