Schneider, Hice, Schakowsky Introduce Bipartisan Bill to Address Medical Device Shortages
Today, U.S. Representatives Brad Schneider (D-IL), Jody Hice (R-GA), and Jan Schakowsky (D-IL) introduced bipartisan legislation (H.R. 6062) to address the timely threat of shortages of medical devices, which can be exacerbated by disruptions to the global supply chain.
This threat of shortage is currently growing as many medical device manufactures that the American health care system depend upon have facilities in China where operations have been affected by the ongoing outbreak of coronavirus (COVID-19).
“The developing coronavirus outbreak is challenging and exposing serious weaknesses in the supply chain for medical devices that providers depend on to deliver life-saving care,” said Schneider. “Our legislation would ensure that manufacturers are communicating with the FDA about expected shortages of medical devices, and that this information is shared transparently and publicly. Importantly, our bill would also allow the FDA to act expeditiously to address shortages, including by importing medical devices. This is the same authority the FDA already wields over prescription medication, and we should similarly empower the agency to ensure access to medical devices.”
“As our nation’s healthcare system mobilizes to confront the threat of coronavirus, our healthcare professionals on the front lines are potentially facing a dangerous shortage of critical medical devices,” said Hice. “This commonsense measure will ensure that the FDA has a strong and open line of communication with medical device manufacturers, and that the agency will have the power to allow the importation of medical devices should we face a shortage. I am proud to be the leading Republican cosponsor on this bill, and I look forward to continuing to work with Representatives Schneider and Schakowsky to quickly advance this life-saving legislation.”
“It is unacceptable that the Food and Drug Administration has no authority to import lifesaving medical devices in case of a shortage or to require companies who make those devices to report when their products face supply chain disruption,” said Schakowsky. “I’m proud to join Representatives Schneider and Hice to introduce this critical legislation to ensure FDA can fulfill their duty to protect public health. There are over 70 facilities in China that produce essential medical devices for the U.S. that are at risk from the coronavirus pandemic, so the Congress must act quickly to pass this bill.”
Specifically, the legislation would:
- Require manufacturers to report an expected shortage of a critical or life-saving medical device;
- Require the FDA to post online a list of medical devices currently in shortage; and
- Grant FDA authority to import medical devices in case of a shortage.
Under current law, drug manufacturers are required to report to FDA an expected interruption or discontinuance in the production of life-saving drugs. FDA posts this information on a public-facing website, and, in extraordinary circumstances related to a shortage, FDA has the authority to import drugs related to that shortage.
However, no similar law exists for our critical medical device supply chain, despite FDA requesting this specific authority in their FY2020 and FY2021 budget requests. This legislation would align those same authorities granted to FDA for drugs as for medical devices. These authorities are critical to managing our country’s medical device supply chain, as evidenced by FDA’s emergency use authorization for respirator shortages related to the spread of COVID-19.
The legislation would also help minimize disruption to the medical device supply chain in the ongoing efforts to regulate fugitive emissions of ethylene oxide (EtO), a medical sterilizer that the U.S. EPA has categorized as a carcinogen.