FDA Approves 'Emergency Rules' for Mass Medication of Population with Anti-Viral Drugs

The FDA has approved using the antiviral drugs Tamiflu and Relenza without many of the normal protections, in response to the Centers for Disease Control and Prevention's (CDC's) declaration of a health emergency in response to H1N1 swine flu.

Under the 2004 Project BioShield Law, the FDA is authorized to make an "Emergency Use Declaration" (EUD) allowing drugs to be used in a manner normally prohibited by federal regulations. This might entail allowing the use of an otherwise unapproved drug, or allowing previously unapproved uses of a drug that is already on the market.

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