The FDA is pressing for new authorities to help mitigate disruptions and shortages.
The medical device supply chain has many vulnerabilities. Weather conditions, transportation bottlenecks, energy crises, geopolitical conflicts, raw material shortages, labor disputes, device recalls, regulatory pressures, and other factors can all cause supply chain failures that could put lives at risk.
In 2022, by exercising regulatory flexibility, sharing information, and developing conservation plans, the CDRH took or informed mitigation action on more than 350 potential and actual medical device shortages.
Back in 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) gave the CDRH the authority to require medical device manufacturers to notify the FDA regarding certain supply chain disruptions “during, or in advance of” a Public Health Emergency (PHE).
Now that the COVID-19 PHE is officially over, what have come to be known as “506J notifications” are currently voluntary and the expectation is that most medical device manufacturers won’t be forthcoming with supply chain information. Prior to the pandemic, the CDRH had requested supply chain information from more than 1,000 manufacturers but about two-thirds ignored the voluntary request.
Calls are being made to revise the FDA’s statutory authority to compel medical device manufacturers to be more collaborative when it comes to preventing shortages and avoiding disruptions. The FDA is requesting that the temporal limitation associated with 506J notifications be lifted and that manufacturers be required to develop and share risk management plans for their most critical devices.
Writing for HealthAffairs in May 2023, Suzanne Schwartz and Tammy R. Beckham, both with the FDA, urged patients and caregivers to lobby Congress to “require manufacturers to develop and conduct risk assessments of potential supply chain vulnerabilities; to require them to develop and implement risk management plans to prevent or mitigate future shortages; and to require them to notify the CDRH of shortages regardless of whether we’re in the midst of a public health emergency.”
The logic is simple: Rather than learning about critical device shortages from “desperate clinicians and patients,” the industry should work with the FDA to prevent shortages and minimize the consequences felt by vulnerable individuals.
Offering to work with manufacturers in the pursuit of more widespread information sharing, the FDA established the Resilient Supply Chain Program (RSCP) for medical devices to:
Whether the FDA requires information sharing or not, establishing risk management plans and acting as soon as a possible supply chain disruption is identified are the best defenses against medical device shortages.
Manufacturers with digitalized supply chain management systems are in the best position to identify signals of potential shortages—and share them with the CDRH through 506J notifications.
Using modern data management technologies—in combination with physical actions like supplier diversification, long-term contracts, and open communication with regulatory bodies—manufacturers can reduce their vulnerabilities and ensure a more stable supply chain. Digitalized supply chain management systems make it easy to:
By leveraging technology, such as automation, artificial intelligence, and data analytics, manufacturers can optimize production processes and improve supply chain visibility. This can help to identify potential bottlenecks and enable faster response to mitigate shortages.
At AX for Pharma, our mission is to give Life Sciences organizations the advanced technology they need for tackling the operational challenges and regulatory changes they face every day. As leaders in business process engineering and improvement, we’ve become a trusted partner for leading pharmaceutical companies, biotech firms, and medical device manufacturers in the U.S., Europe, and Australia.
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The AXP365 Pharma Supply Chain Management™ module is a powerful, state-of-the-art solution used by Life Sciences companies worldwide to track products and raw materials from a growing number of suppliers. The pre-configured, out-of-the-box solution meets or exceeds all Good Automated Manufacturing Practice (GAMP) standards.
Here are just a few of the benefits Life Sciences companies receive from AXP365 Pharma Supply Chain Management™:
As pressure grows to mandate greater visibility into medical device manufacturer supply chains, now is the time to embrace the digital technologies that optimize your supply chain management. By adopting cloud-based, digital supply chain, warehouse, and quality management systems, medical device manufacturers can optimize operations, foster collaboration, and ensure compliance.
To learn how AX for Pharma can help your business drive growth, innovation, and efficiency through its Life Sciences-specific digital ERP modules, please contact us today.