In re Emergency Use Authorization of Medical Products
- Case Date: 9/6/2005
- Project Name: Health Care Project
On September 6, 2005, WLF filed comments with the FDA on the agency's proposed guidance concerning emergency authorization of drugs and medical devices needed in response to a biological, chemical, radiological, or nuclear attack on the United States. WLF's comments expressed support for the guidance, but requested that the FDA clarify its discussion of preemption of state laws. WLF urged that the FDA's assertion of preemption powers be clarified to establish that it covers labeling matters and tort liability. WLF argued that the emergency powers created by Congress to protect the public health would be frustrated by assertions of state or local authority in either of these areas, either to establish contrary or supplemental labeling requirements or to impose tort liability where a manufacturer is acting in compliance with an emergency use authorization.
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9/6/2005: Download the Comments