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FDA Readies Rapid Review for Flu Drugs

November 5, 2005

Bird Flu • Scientists Report Progress Toward Bird Flu 'Cure' • Bird Flu Not the Only Animal Disease Threat • Bird Flu Vaccine Trials 'Encouraging' • FDA Frets about Flu Drugs' Side Effects • World Not Ready For Bird Flu • Researchers: Bird Flu Pandemic Inevitable • Bird Flu Scare in Virginia • FDA Issues Flu Vaccine Guidelines • FDA Approves First Bird Flu Vaccine • More Flu Bugs Show Resistance To Anti-Virals • Seasonal Flu Shot Might Offer Some Bird Flu Protection • Experts Concerned about Tamiflu Overuse • Study Finds Much Bird Flu Planning is Misplaced • U.S. Orders More Bird Flu Vaccine • Scientists Identify Genetic Changes That Could Lead to Bird Flu Pandemic • Drug Interaction Can Render Tamiflu Ineffective • New Bird Flu Variant Renews Pandemic Concerns • Researchers Find New Weapon Against Flu Virus • Researchers Test Spreadability of Bird Flu Viruses to Humans • GlaxoSmithKline Claims Bird Flu Breaththrough • Global Corporations Struggle to Plan For Pandemic • Flu Pandemic Is "Inevitable," EU Experts Warn • Bird Flu Virus May Have Mutated In Indonesian Cases • Indonesian Nurse May Have Bird Flu • Study Warns of "Chaos" and "Panic" If Bird Flu Strikes • Investigators Find No Evidence Bird Flu Virus Has Mutated • Scientists Fear Bird Flu Virus May Have Mutated • Airlines Queasy About Quarantining Bird Flu Victims • More ...

The Food and Drug Administration (FDA) says it is building a team of experts who will be able to approve in "weeks" rather than months vaccines and antiviral medications that would treat a pandemic outbreak of bird flu.

Meanwhile, China reported its fourth bird flu outbreak in three weeks and said it had destroyed about 370,000 birds as a result. Authorities in Japan said they detected signs of bird flu at a northern farm and plan to kill 180,000 chickens. Vietnam confirmed bird flu outbreaks in three northern villages.

Acting FDA head Andrew von Eschenbach said his team would work with other government agencies, including the National Institutes of Health and companies such as Sanofi-Aventis and Chiron Corp. that are working on developing a vaccine that could protect humans against the bird flu.

The H5N1 virus that has infected millions of birds in Asia has recently spread into Europe and public health experts fear the virus may mutate and start spreading among humans. If so, it could spread quickly, sickening and killing millions.

Dr. van Eschenbach said the FDA would also work to quickly approve any generic versions of Roche's antiviral Tamiflu, one of the few medications effective against the flu. Roche has said it would set up licensing arrangements with other companies to produce Tamiflu as part of an effort to boost the supply of the drug, which governments are stockpiling in the event of a flu pandemic.

Dr. von Eschenbach said he hopes to be able to approve new vaccines or drugs in about six to eight weeks rather than the 10 months a typical review process requires.

President Bush has said he would ask Congress for $7.1 billion in emergency funding as part of an effort to handle a pandemic flu outbreak in the U.S., including $800 million to develop new treatments and vaccines and $2.8 billion to develop a new, faster method to produce vaccines that are produced with chicken eggs.

However, none of the funding is earmarked for the FDA.

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