Report on Supply Chain Compliance 3, no. 5 (March 5, 2020)
Republican Sen. Josh Hawley of Missouri announced via Twitter that he would introduce legislation to protect the U.S. medical product supply chain following its disruption caused by the outbreak of the coronavirus in China.
“If the #Coronavirus crisis makes anything clear, it’s that we need to stop relying on #China for our critical medical supply chains. I will introduce legislation this week to jump start that effort. Details to follow.”[1]
In a letter sent to the U.S. Food and Drug Administration, Sen. Hawley asked the following questions:
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“What actions has the FDA taken to date to ensure that American citizens do not face shortages of life-saving drugs and medical devices?
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“What actions will the FDA take in the coming weeks and months to ensure that safe alternatives to any scarce medical products are available for public use?
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“What additional resources has the FDA devoted to identifying vulnerabilities in the U.S. medical product supply chain?
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“What additional statutory authority, if any, does the FDA need to require information from manufacturers about the sourcing of component parts, active pharmaceutical ingredients, or scarce raw materials in the medical products they produce?
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“Will you commit to testifying in congressional hearings about these troubling vulnerabilities in our medical product supply chain and potential policy solutions to keep Americans safe?”[2]
There are more than 50 confirmed coronavirus cases in the U.S. at the time of writing, and “more cases are likely to be identified in the coming days,” said the Centers for Disease Control and Prevention,[3] as the implications of failed quarantines and the frequency of international travel contribute to the spread of the virus.