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Monday, March 8th, 2021

Sen. Hawley seeks answers from FDA on plans to mitigate drug shortages

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U.S. Senator Josh Hawley (R-MO) is seeking answers from the U.S. Food and Drug Administration on how it will mitigate potential drug and medical device shortages.

The inquiry follows a recent report that the recent outbreak of novel coronavirus has threatened the domestic supply of some 150 prescription drugs, including antibiotics, generics, and branded drugs. The report said some of these drugs don’t have alternatives on the market.

“The degree to which some of our own manufacturers rely on China to produce life-saving and life-sustaining medications is inexcusable. It is becoming clear to me that both oversight hearings and additional legislation are necessary to determine the extent of our reliance on Chinese production and protect our medical product supply chain,” Hawley wrote in a letter to
FDA Commissioner Stephen Hahn.

Hawley urged the FDA Commissioner to take swift action to mitigate these shortages. He also seeks answers regarding what actions the FDA has taken to date to ensure that American citizens do not face shortages of life-saving drugs and medical devices; what actions the FDA will take in the coming weeks and months to ensure that safe alternatives to any scarce medical products are available for public use; and what additional resources the FDA has devoted to identifying vulnerabilities in the U.S. medical product supply chain.

He is also seeking response as to what additional statutory authority, if any, the FDA needs to require information from manufacturers about the sourcing of component parts, active pharmaceutical ingredients, or scarce raw materials in the medical products they produce.

His final directed question asks if the FDA Commissioner will commit to testifying in congressional hearings about these troubling vulnerabilities in our medical product supply chain and potential policy solutions to keep Americans safe.