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FDA to speed up Tamiflu production
Worried by bird flu, agency is working to remove road blocks to vaccine, anti-viral production.
October 25, 2005: 1:46 PM EDT
By Aaron Smith, CNN/Money staff writer

NEW YORK (CNN/Money) - The Food and Drug Administration will drastically reduce its review time for bird flu drugs as it tries to build a national stockpile of Tamiflu and newer, experimental drugs, according to the agency's top official.

"Making sure Americans are protected against an outbreak of Avian flu is one of FDA's top priorities," acting FDA commissioner Andrew von Eschenbach said in a statement Monday. "Using the rapid response team approach, we believe we could review a complete drug application in six to eight weeks."

Von Eschenbach was tapped to head the regulatory agency after Lester Crawford resigned late last month just two months after the Senate confirmed him.

The FDA, which normally takes at least six months to review a new drug application, created the rapid response team to ensure that the nation will have an adequate supply of Tamiflu, an anti-viral drug made by Swiss drug maker Roche (up $3.95 to $169.21, Research).

Tamiflu, which has been on the market since 1999, is effective in patients with bird flu, or H5N1, if taken within 48 hours of infection. About half of infected people die.

Bird flu, which can be transmitted from birds to humans, has killed more than 60 people in Asia and has been detected in birds in Turkey, Romania, Russia and South America.

Scientists recently discovered that the 1918 influenza pandemic that killed more than 50 million people worldwide originated in birds and was passed on to humans, igniting fears that it could happen again.

There are two anti-virals on the market: Roche's Tamiflu, a pill, and GlaxoSmithKline's (down $1.06 to $49.93, Research) Relenza, an inhalant, which can both be used against bird flu.

"Americans can be certain that FDA has the best scientific minds working together to ensure we have enough Tamiflu and other medications and to quickly get it to doctors and patients, if ever necessary," said Eschenbach.

The 10-step process used to make Tamiflu is lengthy and complex, and Roche has admitted it may have to farm out production to generic drug makers to keep up with demand.

The FDA said that additional Tamiflu production "can be in full gear within 12 months, with substantial product available, should it be needed."

The FDA said it will partner with commercial drugmakers, university researchers and other government agencies to conduct clinical studies on experimental anti-flu drugs and to ramp up vaccine manufacturing capability.

Also, the FDA waives its usual regulatory requirements on drugs that could be used to prevent widespread illnesses and fatalities, as in influenza outbreaks or bioterrorist attacks.

Roche, which attributed Tamiflu to much of its recent 20% jump in quarterly sales, said it has received Tamiflu orders from 40 countries and would meet with four generic drugmakers to help produce the drug.

Sen. Chuck Schumer, the New York Democrat who pushed Roche to outsource production, identified the generic companies as Teva Pharmaceuticals (down $0.15 to $38.56, Research), Barr Laboratories (up $0.05 to $58.03, Research), Mylan Laboratories (down $0.10 to $21.00, Research) and Ranbaxy Laboratories. Roche said it has been ramping up manufacturing facilities for the last two years.

The Senate has already approved $3.9 billion to stockpile medications against bird flu, which is in addition to the $5.6 billion budgeted to build a stockpile of drugs for a possible bioterrorist attack.

Andreas Theisen, an analyst for German bank WestLB, estimated Roche will receive $1.7 billion to $1.8 billion of that.

Washington has already agreed to pay $97 million to Sanofi-Aventis (down $0.25 to $40.61, Research) of France to produce its experimental vaccine. Many health experts believe a vaccine is the best way to prevent a pandemic.

To read about an experimental new anti-viral for bird flu, click here.  Top of page

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