Complain about a product or service

FDA To Speed Up Tamiflu Production

October 24, 2005

Bird Flu • FDA Gains Insight to Bird Flu Virus • New Flu Bug Proves Resistant to Antiviral Drugs • Report: Nation Not Ready For Flu Pandemic • Antiviral Overuse Could Aid Deadly Flu • 1918 Flu Virus Offers Clues to Prevent Pandemics • 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 has announced formation of a "rapid response team" to ensure that antiviral drugs are available in the event there is a pandemic outbreak of avian flu.

The agency said that, while there is no current flu pandemic, the team will help ensure an adequate supply of treatments, such as Tamiflu, and other anti-influenza drugs, for stockpiling in the event there is an outbreak in the United States.

Currently the disease is rare among humans because it cannot be passed human-to-human, only from infected birds to humans. However, the mortality rate among infected humans is close to 50 percent, raising fears of a public health disaster if the virus mutates so that it can be spread among humans.

"Making sure Americans are protected against an outbreak of Avian flu is one of FDA's top priorities," said Andrew von Eschenbach, MD, Acting FDA Commissioner.

"Using the rapid response team approach, we believe we could review a complete drug application in six to eight weeks. 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," he said.

Van Eschenbach said the team will address roadblocks to increased manufacturing of products, such as Tamiflu, already proven effective against avian flu. It is anticipated that Tamiflu production can be in full gear within 12 months, with substantial product available, should it be needed.

Over the weekend many public health officials expressed concern that healthy patients would stockpile the drug, leading to shortages.

Partnering with industry, academia and other government agencies, the FDA said its team will support the design and conduct of clinical studies to test new potential treatments for avian influenza. In the event of a pandemic, such new medications could be made available under Emergency Use Authorization.

In addition, the team will facilitate the development and availability of safe and effective vaccines that could help protect Americans against a future pandemic, including from Avian flu.

These efforts include measures to help increase vaccine manufacturing capacity and production of currently licensed vaccines using Avian flu strains, and facilitating and evaluating studies that use new technologies.

As the threat of pandemic flu emerges as a public health threat, FDA said it anticipates an increase in the sale of counterfeit or fraudulent treatments. Presently, the agency said it is not aware of any counterfeit Tamiflu cases in the United States, however, there are initiatives in place to deter counterfeiters and parties who sell fraudulent or phony products to treat or prevent Avian flu.

FDA said it will continue to work with stakeholders in the U.S. drug distribution system to strengthen the safety and security of the domestic drug supply and will continue to:

• Actively monitor internet sites and will partner with internet service providers to identify and stop fraudulent activity.

• Aggressively seek out and prosecute those who seek to prey on innocent people in a time of crisis.

• Encourage pharmaceutical manufacturers to take advantage of new technologies that provide protective packaging and other features to ensure the product is both authentic and has not been tampered with.

The FDA Counterfeit Alert Network said it is ready and available to help disseminate information in the event of counterfeit incident. The Counterfeit Alert Network is a partnership between FDA and numerous organizations that have agreed to distribute FDA approved messages to their members about counterfeits on a timely basis to assure rapid action to minimize the risk of exposure to counterfeits.

In the event of a confirmed counterfeit case in the U.S., FDA will send an Alert to these partners. FDA will send out an FYI notice to partners if a counterfeit incident is confirmed elsewhere in the world that could affect U.S. patients.

To minimize the risk of counterfeit or fraudulent flu treatments, the FDA recommends the following:

• Consumers should buy medicines only from U.S. state-licensed pharmacies.

• When buying medicines over the Internet, consumers should look for the National Association of Boards of Pharmacy VIPPS seal. This seal tells consumers that the web site has been certified, and if people want to buy a medicine on line, this is a legitimate pharmacy to purchase it from.

• Only use medicine that has been prescribed for you by your doctor and do not rely on websites that will provide you with a prescription for the medicine without a true doctor-patient relationship.

Report Your Experience
If you've had a bad experience -- or a good one -- with a consumer product or service, we'd like to hear about it. All complaints are reviewed by class action attorneys and are considered for publication on our site. Knowledge is power! Help spread the word. File your consumer report now.