FDA Approves Special Use of Drugs, Tests for Swine Flu

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    * APRIL 27, 2009, 5:28 P.M. ET

FDA Approves Special Use of Drugs, Tests for Swine Flu

By ALICIA MUNDY

The Food and Drug Administration authorized certain emergency uses of antiviral drugs and tests in connection with the swine flu outbreak, officials at the Department of Health and Human Services said.

The orders signed early Monday, called Emergency Use Authorizations, permit the Centers for Disease Control and Prevention to diagnose swine flu using a test that has yet to be formally approved by the FDA.

The test is available only in a few government laboratories, and will be used mostly to review samples sent by state or local health authorities. It isn't designed for widespread use at clinics or ports where travelers are screened.

Another authorization signed Monday allows physicians to give a widely used drug, Tamiflu, to children less than one year old. Tamiflu is not approved for such infants. The order includes FDA guidance to doctors on dosing levels for infants. Tamiflu is made by Roche Holding AG.

The third emergency authorization allows the inhalant Relenza, made by GlaxoSmithKline PLC, to be used in treating suspected cases of swine flu and dispensed to patients in hospitals.

The emergency authorizations signal the FDA's concurrence with the CDC's actions during the swine flu outbreak, which helps protect the government, doctors and hospitals from medical and legal challenges, as well as some liability claims.

Emergency-use authorizations were begun under the Project Bioshield Act of 2004 involving U.S. responses to pandemics or bioterrorism. They require rapid and detailed cooperation between the FDA and CDC. In past case, relations between the two agencies have been marked by turf battles, including during the avian flu crisis, according to former FDA Deputy Commissioner Scott Gottlieb.

In the swine-flu case, the FDA authorizations were "very smooth and very fast," said an administration official.

Write to Alicia Mundy at alicia.mundy@wsj.com

http://online.wsj.com/article/SB124086713591160779.html