FDA Authorizes Emergency Use of Tamiflu and Relenza to Treat Swine Flu

In response to requests from the US Centers for Disease Control and Prevention (CDC), the US Food and Drug Administration has authorized the use of the antiviral drugs Tamiflu and Relenza beyond their approved indications in response to the outbreak of swine flu. The FDA is empowered to make such Emergency Use Authorizations (EUAs) under Project BioShield, which became law in July 2004.

Tamiflu, made by Roche, is approved for the treatment and prevention of influenza in patients one year and older, but the new authorization allows the drug to be used in children under one year, and to provide alternate dosing recommendations for children older than one year.

In addition, under the new authorizations, both Tamiflu and GlaxoSmithKline’s Relenza, approved for children five and older, may now be distributed to large segments of the population without complying with the label requirements otherwise applicable to dispensed drugs. They also may be distributed by a broader range of healthcare workers, including some public health officials and volunteers, in accordance with applicable state and local laws or public health emergency responses.

The EUA authority allows the FDA to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met. The authorization will end when the declaration of emergency is terminated or the authorization revoked by the agency.