FDA Seeks Broader Authority to Prevent Medical Device Shortages
When Rahm Emanuel, the White House Chief of Staff under President Obama at the time, famously said, “Never let a serious crisis go to waste,” he was referring to the Great Recession. It represents an opportunity, he went on to say, to do things and enact policies that seemed impossible before. The statement could equally apply to the early days of the COVID-19 pandemic, which revealed an alarming domestic shortage of personal protective equipment and some medical devices. The lessons learned from that crisis is what an FDA Fact Sheet seeks to address.
Published earlier this month, “Mitigating and Preventing Medical Device Shortages and Prioritizing Public Health” notes that “COVID-19 exposed the weaknesses in our national supply chain, particularly in terms of our dependence on devices and components imported from China and other countries.” Under the CARES Act of 2020, FDA’s Center for Devices and Radiological Health (CDRH) received new statutory authority to help mitigate and prevent device shortages during or in advance of a public health emergency (PHE). In the fact sheet, FDA makes the case that this authority should be broadened.
The CARES Act does not grant CDRH the ability to intervene outside of a PHE, but medical device shortages can occur during a natural disaster or after a medical device recall, argues FDA. “CDRH would be in a much better position to prevent and mitigate these shortages if it were to have more comprehensive statutory authority to help strengthen medical device supply chains,” notes the fact sheet.
The CARES Act allowed CDRH for the first time to monitor the “complex web of supply chains that feed the medical device industry” and preemptively find solutions for brewing problems. The agency worked with manufacturers to ease some shortages and prevent others from happening at all. “For example, CDRH worked with testing and diagnostics manufacturers to help ease shortages of resins that were the result of the 2021 Texas winter storm. This work helped avert disruptions and shortages in COVID-19 diagnostic test availability,” says FDA.
The opportunity emerging from the pandemic crisis, as far as FDA is concerned, would be an expansion of its statutory authority. At the beginning of the pandemic and before the agency had CARES-sanctioned authority, it reached out to more than 1,000 manufacturers to request supply chain information, it writes in the fact sheet. “Only about one-third responded, and often incompletely, because the FDA’s requests for this information were voluntary. As a result, we were forced to play catch up when shortages emerged.”
In the document, FDA asks that the statutory authority be revised to “require notifications from manufacturers to CDRH any time there is the potential for a device shortage . . . and not just during or in anticipation of a PHE. Without more comprehensive authority, our device supply chain and US public health remain at risk,” writes FDA.
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