According to a press release, Representatives Mike Gallagher (who represents district 8 in Wisconsin) and Mark Pocan (who represents district 2 in Wisconsin) introduced the Medical Supply Chain Security Act today. The release states that 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.
Pocan stated:
“We need this legislation because currently no law exists requiring medical device manufacturers to notify the FDA when they become aware of a potential shortage 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 release says that the 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.
See the attachment below to read the full text of the bill.
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