FDA Authorizes Emergency Use of Tamiflu, 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 yesterday 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), as they are called, under Project BioShield, which became law in July 2004.

Tamiflu, made by Roche, is approved for the treatment and prevention of influenza in patients 1 year and older, but the new authorization allows the drug to be used in children under 1 year, and to provide alternate dosing recommendations for children older than 1 year.

In addition, under the new authorizations, both Tamiflu and GlaxoSmithKline’s Relenza, approved for children 5 and older, may now be distributed to large segments of the population without complying with the label requirements otherwise applicable to dispensed drugs. They may also 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 agency also issued an emergency use authorization for the rRT-PCR Swine Flu Panel diagnostic test, believing it may be effective in testing samples from individuals diagnosed with influenza A infections, whose virus subtypes cannot be identified by currently available tests.

This EUA allows the CDC to distribute the swine flu test to public health and other qualified laboratories that have the needed equipment and the personnel who are trained to perform and interpret the results.

A positive result indicates that the patient is presumptively infected with swine flu virus. A negative result, however, does not, by itself, exclude the possibility of swine flu virus infection.

The EUA authority allows the FDA, based on the evaluation of available data, 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.

GSK announced yesterday that it is urgently assessing mechanisms to increase production of Relenza. Since the start of the outbreak, GSK also has supplied 100,000 packs of Relenza and 170,000 additional doses of its seasonal influenza vaccine to the Mexican authorities, at their request.

For FDA’s Emergency Use Authorization of Medical Products Guidance, go to http://www.fda.gov/oc/guidance/emergencyuse.html