In the Headlines
October 22, 2024

Drug-Shortage List Under Scrutiny After FDA Reversal

Law360

Healthcare policy attorney Michael Werner was quoted in a Law360 article discussing the potential implications of the U.S. Food and Drug Administration's (FDA) recent reversal on the drug shortage status of tirzepatide, a popular weight loss and diabetes medication. The article explored how this unusual move by the FDA, following a lawsuit from drug-compounding facilities, might influence future decisions on drug shortages and impact patient access to medications. Mr. Werner highlighted the case's importance and its potential to increase public awareness of the FDA's drug shortage list procedures.

"This could be an issue that has far-reaching implications," he said. "Up until two weeks ago, there were probably two or three dozen people in the whole world that understood the FDA shortage list process. Now everybody knows."

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