Washington, D.C. – U.S. Senators Bob Casey (D-PA) and Kelly Loeffler (R-GA), two members of the Senate Health, Education, Labor and Pensions (HELP) Committee, introduced a bill to prevent shortages of essential medical devices during a national emergency or public health epidemic.
The Preventing Essential Medical Device Shortages Act of 2020 (S. 3468) will provide the U.S. Department of Health and Human Services (HHS) the flexibility it needs to work with the private sector to ensure essential medical devices are continuously available, even when facing a shortage. The bill also protects public health by requiring manufacturers of essential medical devices to notify the Secretary of HHS, acting through the Food and Drug Administration (FDA), of anticipated disruptions or permanent discontinuations of manufacturing in the supply chain, as well as authorizing new tools for the Secretary to prevent or mitigate shortages and requiring a Government Accountability Office report on risks in the supply chain of essential devices.
“Millions of Americans rely on essential medical devices, including masks, gloves, ventilators and IV fluid bags,” said Senator Casey. “We must ensure that our health care providers and first responders are well equipped to swiftly respond to the needs of patients during any public health crisis, including pandemics and natural disasters. I introduced the Preventing Essential Medical Device Shortages Act of 2020 to improve supply chain communication and give the FDA the authority to help expedite device applications or inspections, when needed, in order to mitigate or prevent a shortage of medical devices.”
“As we know through our response to COVID-19, preparation is part of prevention, and we must have policies that prevent shortages of essential medical devices,” said Senator Loeffler. “Whether it’s an outbreak or a community hit by a natural disaster, disrupted supply chains hinder our ability to protect the American people. Through the Preventing Essential Medical Device Shortages Act of 2020, HHS will have the tools and resources it needs to minimize the impact of future essential medical device shortages, and keep Americans safe and healthy.”
The Preventing Essential Medical Device Shortages Act of 2020 would:
- Requires the Secretary of Health and Human Services to issue public regulations defining the term ‘essential device;
- Adds essential devices to the drug shortage list in the Federal Food, Drug and Cosmetic Act;
- Requires essential device manufacturers to notify the Secretary about anticipated permanent discontinuance or interruption in an essential device manufacturing supply chain;
- Makes information publicly available about disruptions in order to inform physicians, health providers and patient organizations about anticipated shortages;
- Allows the Secretary to exempt certain device shortages from public disclosure if it may lead to hoarding, price spikes and other issues that could adversely affect public health;
- Allows the Secretary to expedite the review of medical device applications to help mitigate anticipated shortages;
- Authorizes the Secretary to expedite the inspection or re-inspection of establishments that could help mitigate or prevent shortages; and
- Requires a Government Accountability Office report to examine the intra-agency coordination process that assesses risks associated with the essential device supply chain and identify ways to mitigate these risks.