FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in HumansApril 28, 2009
By Susan J. Matthees –
At the request of the Centers for Disease Control and Prevention ("CDC"), FDA announced last night that it would issue Emergency Use Authorization ("EUA") of flu medicines and diagnostic tests in response to the recent swine flu outbreak. Two antiflu drugs, Tamiflu and Reneza, and the rRT-PCR Swine Flu Panel diagnostic test were given EUAs. Both Tamiflu and Reneza have been approved to treat influenza, but the EUAs allow for Tamiflu to be used in children under age 1 and broadens the dosing recommendations for children older than 1 year. The EUA gives CDC the ability to distribute the rRt-PCR Swine Flue Panel diagnostic test to qualified personnel who can perform the test and interpret the results.
FDA was given authority to grant EUAs as part of the Project BioShield Act of 2004, which amended section 564 of the Federal Food, Drug, and Cosmetic Act ("FDC Act") to allow FDA to authorize use of an unapproved or uncleared medical product or unapproved or uncleared uses of a medical product during a declared emergency. The Secretary of Health and Human Services can declare an emergency based on a determination of an emergency by the Secretary of Homeland Security, the Secretary of Defense, or on his or her own determination of a public health emergency. (See FDA guidance document here.) In this case, the Department of Health and Human Services made a determination that swine flu created a national public health emergency on Sunday.
This is not the first time that FDA has authorized EUAs. FDA authorized EUAs for anthrax vaccines for individuals deemed to be at high risk of exposure to an anthrax attack. In fall 2008, FDA authorized use for doxycycline hyclate tablet emergency kits.
FDA will soon issue a Federal Register notice announcing the specific content of the EUA. In the meantime, CDC published its treatment recommendations for the emergency use of these products on their website this morning.