The FDA is requesting more regulatory power over the medical device supply chain to mitigate and prevent supply shortages, acting Commissioner Janet Woodcock, MD, wrote in a July 21 blog post.
Under the Coronavirus Aid, Relief, and Economic Security Act, passed in March 2020, the FDA gained the authority to collect information from medical supply manufacturers about supply chain disruptions to help prevent and mitigate shortages caused or exacerbated by the COVID-19 pandemic. However, the FDA isn't allowed access to such information when there isn't a public health emergency.
The pandemic has shown that once a public health emergency begins, it's already too late to build an infrastructure to prevent or mitigate shortages, Dr. Woodcock wrote. She added that situations such as hurricanes and other natural disasters that may not be considered public health emergencies could significantly affect the medical device supply chain.
"To assure a more resilient domestic supply chain, prevent shortages before they occur, and reduce dependence on foreign production, the FDA needs expanded authority to obtain supply disruption notifications for critical devices any time there is the potential for a shortage," Dr. Woodcock wrote.
The agency is also requesting Congress grant it the authority to require medical supply manufacturers to develop and share risk-management plans and identify alternate suppliers and manufacturing sites. Additionally, it is requesting the authority to allow temporary importation of unapproved devices when it is in interest of public health.
"The establishment of a permanent device shortages program will help ensure U.S. patients and health care providers have access to the critical medical devices they need and help reduce U.S. dependence on devices from other nations," Dr. Woodcock said.
Read the full post here.