The number of people with COVID-19 in the United States climbed March 3, with Washington state reporting three more deaths. According to the Centers for Disease Control and Prevention (CDC) figures as of March 4, 80 people have been infected in 13 U.S. states, including presumed cases reported by public health laboratories.
In a bipartisan House initiative, Reps. Mike Gallagher (R-Wis.) and Mark Pocan (D-Wis.) introduced on March 2 the Medical Supply Chain Security Act.
“Our overreliance on products made in China doesn’t just threaten our medical supply chains. It threatens public health,” Gallagher said in a statement.
Pocan said, “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.”
Sen. Josh Hawley (R-Mo.) introduced companion legislation in the Senate last week.
The coronavirus outbreak in China has shed light on what Hawley’s office called “severe, longstanding, and unresolved vulnerabilities in the U.S. medical product supply chain,” which threaten shortages of essential medical goods as many Chinese factories remain closed in an attempt by the Chinese regime to prevent further spread of the virus.
The Food and Drug Administration (FDA) recently identified about 20 drugs that solely source their active pharmaceutical ingredients or finished drug products from China, the agency said, while Health and Human Services (HHS) Secretary Alex Azar told Congress on Feb. 25 that the United States has a stockpile of about 30 million respiratory masks, but might need as many as 300 million during the outbreak.
“This is more than unfortunate,” Hawley said in a statement. “It’s a danger to public health.”
Last week, the FDA said it’s aware of 63 manufacturers, representing 72 facilities in China, that manufacture “essential medical devices” that may be more prone to shortages due to a supply chain disruption.
The Medical Supply Chain Security Act (pdf) would give the FDA the authority to analyze sourcing locations of medical products and, in case of shortages, help bring products to market faster.
“Our health officials need to know the extent of our reliance on Chinese production so they can take all necessary action to protect Americans,” Hawley said. “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.”
The new bill will require that manufacturers report to the FDA imminent or forecasted shortages of life-saving or life-sustaining medical devices. That would let the FDA expedite the review of essential medical devices that require pre-market approval in the event of an expected shortage reported by a manufacturer.
“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,” Gallagher said.
The measure also will give new authority to the FDA to request information on essential drugs or devices from manufacturers. The new notification requirements would cover all aspects of manufacturing capacity, including sourcing of component parts and active pharmaceutical ingredients, along with any other information that federal authorities need to assess the security of the U.S. medical product supply chain.
“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,” said Pocan.
Public health officials have urged common-sense steps to prevent contracting and spreading the novel coronavirus, such as frequent hand-washing and staying home when sick.