Hawley’s office provided Fox News with a copy of the bill, entitled “The Medical Supply Chain Security Act,” along with an outline of its contents.
The proposal’s main function would be to amend the 1938 Federal Food, Drug, and Cosmetic Act to have the words “or device” listed, to allow the Food and Drug Administration to monitor medical device shortages with greater accuracy and efficiency.
The bill would swap the words “shortage of a drug” for “shortage of a drug or device,” and allow the FDA to expedite the review of essential medical devices that require pre-market approval.
Drug and medical device manufacturers would be obligated to provide the FDA with an annual report about their manufacturing capacity, as well.
If the bill 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 deems necessary.
Earlier this week Hawley sent a letter to the FDA demanding answers about what is being done to offset potential drug and medical device shortages. He also called for the U.S. to consider restricting all commercial travel to and from China and requested outlines from federal agencies about their strategy for implementing such restrictions.
The Missouri Republican said the issue is a “danger to public health” and called on government officials to “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,” he said.
As of Wednesday evening, nearly 2,800 people have died from the coronavirus outbreak worldwide, and more than 80,000 have been sickened.