Reps. Mike Gallagher (R-WI) and Mark Pocan (D-WI) introduced the House companion legislation to Sen. Josh Hawley’s (R-MO) medical supply chain bill.
Josh Hawley and the House lawmakers’ legislation would strengthen the medical supply chain by granting the U.S. Food and Drug Administration (FDA) the authority to analyze sourcing locations of pharmaceuticals and medical devices to address medical device shortcomings.
The Missouri senator introduced the legislation after reports revealed that the coronavirus had jeopardized the “domestic supply of some 150 prescription drugs, including antibiotics, generics, and branded drugs.”
Gallagher said in a statement Tuesday:
Our overreliance on products made in China doesn’t just threaten our medical supply chains. It threatens public health. 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.
The legislation would:
- Require that manufacturers report imminent or forecasted shortages of medical devices to the FDA as they currently do for pharmaceutical drugs.
- Allow the FDA to expedite the review of essential medical devices that require pre-market approval in the event of expected shortages reported by a manufacturer.
- Grant the FDA additional authority to request additional information from manufacturers of essential drugs or devices regarding their manufacturing capacity, including sourcing of component parts, sourcing of active pharmaceutical ingredients, use of raw materials, and any other details the FDA might find relevant to assess the security of the American medical supply chain.
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. 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.
Hawley has charged the legislation would provide the information necessary to secure the medical supply chain. He said:
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 device.
Hawley said Tuesday that Congress needs to pass an emergency spending on the coronavirus and secure America’s supply chain as soon as possible.
My legislation to secure our medical supply chains & reduce dependence on #China already has bipartisan support in the House. Proud to be joined by @RepGallagher & @repmarkpocan. Congress needs to pass emergency funding for #coronavirus AND secure our medical supply chain ASAP
— Josh Hawley (@HawleyMO) March 3, 2020
Sean Moran is a congressional reporter for Breitbart News. Follow him on Twitter @SeanMoran3.