WASHINGTON, D.C. – As the coronavirus outbreak raises concerns of medical supply shortages, Rep. Mike Gallagher (R-WI) and Rep. Mark Pocan (D-WI) today introduced the Medical Supply Chain Security Act. This bill would strengthen medical supply chains by giving the U.S. Food and Drug Administration (FDA) the authority to analyze sourcing locations of medical products and help more quickly bring products to market should shortages exist. Senator Josh Hawley (R-MO) introduced companion legislation in the Senate last week. Click here for bill text.
“Our overreliance on products made in China doesn’t just threaten our medical supply chains. It threatens public health,” said Rep. Gallagher. “As the coronavirus outbreak highlights how vulnerable access to critical medicines and medical products can be, it’s clear we need to find better ways to assess vulnerabilities within our medical supply chain. By allowing the FDA to identify our overreliance and swiftly take the necessary corrective actions, this bill would allow us to get upstream of potential shortages and better protect Americans access to critical medicines and lifesaving supplies.”
“With the continued spread of the coronavirus resulting in numerous deaths in the United States, it is imperative that we provide the FDA with tools they need to better prepare for responses and shortages in medical supplies,” said Rep. Mark Pocan. “We need this legislation because currently no law exists requiring medical device manufacturers to notify the FDA when they become aware of a potential shortages or even requiring them to respond to the FDA’s requests for information about the medical device supply chain. Due to our dependence on foreign manufacturing, we need to better understand the threat that supply chain shortages for life-saving medical devices have on patients in America, and we must ensure our government is able to prepare accordingly.”
“The coronavirus outbreak in China has highlighted severe and longstanding weaknesses in our medical supply chain. This is more than unfortunate; it’s a danger to public health. Our health officials need to know the extent of our reliance on Chinese production so they can take all necessary action to protect Americans. This legislation will give us the information we need to better secure our supply chain and ensure that Americans have uninterrupted access to life-saving drugs and medical devices,” said Sen. Hawley.
The Medical Supply Chain Security Act would:
- Require that manufacturers report imminent or forecasted shortages of life-saving or life-sustaining medical devices to the FDA just as they currently do for pharmaceutical drugs. This new information on devices would be added to the FDA’s annual report to Congress on drug shortages.
- Allow the FDA to expedite the review of essential medical devices that require pre-market approval in the event of an expected shortage reported by a manufacturer.
- Give new authority to the FDA to request information from manufacturers of essential drugs or devices regarding all aspects of their manufacturing capacity, including sourcing of component parts, sourcing of active pharmaceutical ingredients, use of any scarce raw materials, and any other details the FDA deems relevant to assess the security of the U.S. medical product supply chain.
Last week, Axios reported that domestic supplies of nearly 150 drugs may face shortages due to production slowdowns in China. But despite requests for more authority to assess what medicines and medical devices may be subject to shortages, FDA officials are limited as to how they can measure vulnerabilities within the medical supply chain. This bill builds upon the FDA’s request in their Congressional Budget Justification for fiscal year 2021 and ensures they have the tools they need to understand domestic reliance on Chinese production and combat those vulnerabilities.