September 10, 2009
By David Gutierrez
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.
The new rules will remain in effect until withdrawn by the FDA or until the declaration of health emergency is lifted.
Roche’s Tamiflu is normally authorized only for use in people aged at least one year, but the EUD now allows the drug to be used for people of any age, and at higher-than-usual doses for those above age one. Both Tamiflu and GlaxoSmithKline’s Relenza may now be distributed without complying with the usual labeling requirements, and may be dispensed by a wider variety of health care workers than is normally allowed.
Relenza is still approved only for use in children aged five and up.
The EUD also allows the use of a flu diagnostic test, known as rRT-PCR Swine Flu Panel, to help health professionals determine whether an individual is actually infected with the H1N1 swine flu or with a different influenza strain.
GlaxoSmithKline has announced plans to ramp up production of Relenza and has distributed 100,000 doses of the drug to Mexico, where stocks have been dwindling.
Until it declares an end to the swine flu health emergency, the CDC recommends that people wash their hands often with soap and water; avoid touching their eyes, nose or mouth; cover their nose and mouth with a tissue when sneezing; avoid contact with infected individuals; and stay home if they become ill.