Woodcock: FDA needs expanded authority on device shortages
The US Food and Drug Administration's (FDA) Acting Commissioner Janet Woodcock on Wednesday made a push for new funding to increase the resilience of the medical device supply chain and to expand the agency's authority to collect information about device shortages."The pandemic has exposed great weaknesses in the medical device supply chain and its dependence on foreign medical devices. To ensure the US is properly prepared now, and in the future, we must take action to secure our medical device supply chain, including related materials, parts, and components," Woodcock wrote in a blog post, acknowledging that doing so will require greater resources and authority than currently allotted to the agency.
Prior to the passage of the Coronavirus Aid, Relief, and Economic Security (CARES) Act in the early days of the COVID-19 pandemic, medical device makers, unlike drugmakers, were not required to report shortages or discontinuations of their products to FDA. However, the CARES Act gave FDA limited authority to collect information about supply interruptions or discontinuations of devices during a declared public health emergency (PHE).
The CARES act also requires FDA to maintain lists of devices reported to be in shortage or discontinued. In May 2020, FDA issued immediately effective guidance explaining the notification requirements for device makers and in August began listing devices that are in shortage or are discontinued. (RELATED: CDRH explains notification requirements for device shortages under CARES Act, Regulatory Focus 6 May 2020; FDA lists medical devices in shortage under CARES authority, Regulatory Focus 14 August 2020)
"These new authorities have enabled the agency to collect information submitted by manufacturers about supply chain disruptions to help prevent and mitigate the impact of critical shortages caused or exacerbated by the COVID-19 pandemic. However, the statutory authorities relating to device shortages are more limited than those available to respond to drug shortages," Woodcock wrote. These limitations, she said, put the agency behind in responding quickly to potential shortages.
Woodcock also stressed that by the time a PHE has been declared, supply chain disruptions may already be underway and that many emergencies that could result in supply chain disruptions do not result in national PHE declarations.
"FDA needs expanded authority to obtain supply disruption notifications for critical devices any time there is the potential for a shortage (removing the temporal limitation to PHEs). In addition, the FDA has requested that these notifications include production volume information to help facilitate conducting fuller oversight of supply chain disruptions," Woodcock wrote, noting that FDA is also seeking the authority to require manufacturers to develop risk management plans and identify alternate suppliers and manufacturing sites and the authority to temporarily authorize the importation of unapproved devices in the interest of the public health.
In its budget request for FY2022, FDA is also seeking $21.6 million for a new Resilient Supply Chain and Shortages Prevention Program (RSCSPP) within the Center for Devices and Radiological Health (CDRH). (RELATED: Biden’s first budget request seeks $6.5 billion for FDA, Regulatory Focus 1 June 2021)
"This funding will provide, for the first time, resources to establish a permanent program for US supply chain resilience for medical devices," Woodcock said. The program would build on work initiated under the CARES Act last year and focus on measures to prevent, and identify medical device shortages.
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