As concerns mount over the spread of the coronavirus and the availability of medical supplies, should the threat of infection increase, U.S. Senator Josh Hawley (R-Mo.) is introducing legislation to help guarantee the United States medical product supply chain is functioning well.
The Medical Supply Chain Security Act comes behind reports by news outlets of a potential drug shortage due to the effect of the coronavirus on Chinese drug manufacturers.
In a press statement Thursday, Senator Hawley 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 devices,” Hawley continued.
Hawley and other lawmakers wrote to the Food and Drug Administration trying to find out if there is or will be a shortage of drugs and other medical supplies needed in the event of a wide-spread infection.
On February 23, “Axios reported that the recent outbreak of novel coronavirus threatens the domestic supply of some 150 pharmaceutical drugs, including antibiotics, generics, and branded drugs. Some of these drugs do not have alternatives in the market. This follows reports of wide-spread shortages of surgical masks and other personal protective equipment.”
Currently, public health officials are not able to accurately measure and assess the vulnerability of our medical supply chain.
Hawley’s bill will give the FDA the authority “to require that manufacturers of medical devices notify the FDA when they become aware of circumstances that may lead to the shortage of an essential medical device.”
With mandatory reporting in place, the FDA will be able to better assess if there are weaknesses to the U.S.’s medical supply chain.
Drug and medical device manufacturers would be obligated to provide the FDA with an annual report about their manufacturing capacity, as well.
If his legislation became law, manufacturers would have to disclose details about “all locations of production, the sourcing of all component parts, the sourcing of any active pharmaceutical ingredients, and the use of any scarce raw materials.”
They would also be subject to FDA requests for any supply chain information that the agency needs to ensure the manufacturing of adequate numbers of medical supplies.
“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,” he said.
In a January letter, Hawley wrote to the FDA, recommending that they restrict all travel from China and asked for an outline of the agency’s strategy implementing these types of restrictions.
The Missouri Senator urged public health officials to “take all necessary action to protect Americans.”
According to the CDC’s website, as of Feb. 26, there were 445 people tested for the virus, and 14 confirmed cases in the United States. Globally, 38 countries have reported cases of coronavirus infections.