Preparing and Packaging for Flu Pandemic

by Daphne Allen, Editor

FDA asks manufacturers to protect products with packaging that deters counterfeiting and tampering.

FDA has asked the drug industry to prepare for pandemic flu, and packaging may play a significant role. Production of antiflu drugs and vaccine development will both need stepping up, and FDA is encouraging manufacturers to use protective packaging for authentication and tamper evidence.

In an announcement made October 24, 2005, the agency detailed its Rapid Response Team formed to combat pandemic flu, which could be caused by the avian flu. “Making sure Americans are protected against an outbreak of avian flu is one of FDA’s top priorities,” said FDA’s acting commissioner Andrew von Eschenbach, MD, in an agency press release. “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.”

In partnership with the U.S. Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention, the National Institutes of Health (NIH), and industry, FDA’s Rapid Response Team will work to increase manufacturing of Tamiflu (oseltamivir phosphate) and other products. (The antiviral Tamiflu has been reported as the first line of defense against avian flu.) FDA expects that Tamiflu production can be in full gear within 12 months.

FDA will also facilitate the review of new vaccines and new flu treatments. “In the event of a pandemic, such new medications could be made available under Emergency Use Authorization,” says the agency.

Protecting these flu treatments and vaccines from counterfeiting and tampering is a priority. To do so, the agency will do the following:

• Actively monitor Internet sites and 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.

These recommendations come just days after nearly 1000 ExxonMobil employees were given fake flu shots at a health fair in Texas. According to reports by CNN, a nurse hired by the company to give the shots noticed some irregularities regarding lot numbers and contacted the FBI. For information, visit www.fda.gov/bbs/topics/ NEWS/2005/NEW 01248.html.

In other news related to flu vaccines, Chiron Corp. announced in late October that it had won a contract from the Department of Health and Human Services to stockpile the U.S. government with vaccines in 2006 to protect against avian flu. The vaccine is based on an inactivated strain of the H5N1 avian influenza virus that has infected people in Southeast Asia. Chiron has studied H5N1 since 1997. Chiron is also providing its H5N1 vaccine candidate for study by the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH under HHS. NIAID/NIH had previously studied Chiron’s H9N2 avian influenza vaccine candidate (along with its MF59 adjuvant), based on the H9N2 influenza strain that caused three people to become ill in Hong Kong in 1999 and 2003.

Chiron says that this contract will not interfere with its annual production of Fluvirin flu vaccine.

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