Reasons for Tamiflu EUA

May 2, 2009 7:50 PM ET

• Tamiflu is an FDA-approved antiviral prescription drug for treatment of uncomplicated acute (mild) illness due to influenza infections in patients 1 year and older who have been symptomatic for no more than 2 days.  Tamiflu is also approved for prevention of influenza in patients 1 year of age and older.
• A Public Health Emergency has been declared due to the outbreak of H1N1 Flu infections identified in the United States.
• The Acting Commissioner of the Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Tamiflu to treat and prevent influenza in patients less than 1 year of age. The emergency use authorization also allows for use at later time points (i.e., patients who are symptomatic for more than 2 days) and/or in patients sick enough to require hospitalization (severe illness).
• The EUA also authorizes Tamiflu to be accompanied by certain written emergency use information.
• During an emergency, normal prescribing and dispensing requirements may not be met for Tamiflu.  Therefore, the EUA for Tamiflu also authorizes distribution or dispensing of Tamiflu without all of the FDA-required prescription label information (e.g. patient’s name, doctor’s name, and date of dispensing).
• The EUA also authorizes distribution of Tamiflu deployed from the Strategic National Stockpile and that has had its expiration date extended under the federal government’s Shelf Life Extension Program (SLEP).
• The EUA also notes that public health officials or other volunteers may distribute Tamiflu to recipients in accordance with applicable state and local law and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction.