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Bayer Commended for Ending 5-Year Opposition to FDA Ban

by 5m Editor
8 September 2005, at 12:00am

US - The Keep Antibiotics Working (KAW) coalition commended the Bayer Corp. for its decision today to end its five-year battle against efforts by the U.S. Food and Drug Administration (FDA) to ban the use in poultry of Baytril, an antibiotic that is nearly identical to the key human-use antibiotic Cipro.

Bayer Commended for Ending 5-Year Opposition to FDA Ban on Use of Cipro-like Antibiotics in Poultry - US - The Keep Antibiotics Working (KAW) coalition commended the Bayer Corp. for its decision today to end its five-year battle against efforts by the U.S. Food and Drug Administration (FDA) to ban the use in poultry of Baytril, an antibiotic that is nearly identical to the key human-use antibiotic Cipro.

The FDA originally proposed banning poultry-Baytril in October 2000. On July 28, 2005, FDA Commissioner Dr. Lester Crawford issued the FDA's final decision (see http://www.fda.gov/bbs/topics/news/2005/new01212.html ), marking the agency's first-ever decision to curtail use of an agricultural antibiotic because of concerns about antibiotic resistance affecting humans.

On August 26, Bayer, the Animal Health Institute (an agricultural drug trade group) and veterinary groups asked the FDA to issue an administrative stay of the ban's September 12 effective date for an indefinite period to allow Bayer to seek judicial review of the ban. On September 2, the FDA denied the request for a stay. Today, Bayer announced that it has decided not to seek judicial review of the ban and thus will not seek a stay pending such review. Accordingly, the ban will take effect as scheduled on September 12.

Both Baytril and Cipro are members of the fluoroquinolone class of antibiotics. Bayer was the only remaining manufacturer of fluoroquinolones for use in poultry. Abbott Labs previously manufactured fluoroquinolones for poultry use, but voluntarily withdrew its product from the market in 2000 when the FDA indicated it intended to propose a ban on this use. The ban affects only use of Baytril in poultry; other approved veterinary uses of Baytril are not affected.

"We applaud Commissioner Crawford for defending the public's health and Bayer for finally recognizing the need to comply with the FDA's ruling," said Karen Florini, senior attorney at Environmental Defense and chair of the Keep Antibiotics Working coalition. "Cipro is a critical antibiotic for treating human illness. It simply makes no sense to allow its effectiveness to be squandered by continued use of near-identical drugs in poultry flocks."

The FDA has shown that use of Baytril in poultry reduces the effectiveness of Cipro in treating Campylobacter, one of the most common causes of severe bacterial food poisoning. The most recent data from the Centers for Disease Control and Prevention show that resistance to Cipro in Campylobacter in humans rose to 21 percent as of 2002; when Cipro-like drugs were first approved for use in poultry in 1995, such resistance was negligible. Although Bayer claims Baytril is critical for poultry production, most top producers - including Tyson, Gold Kist, Perdue, Foster Farms, and Claxton - have announced they now raised broiler chickens without any use of Baytril. Among major chicken purchasers, McDonald's, Wendy's, Dairy Queen, Burger King, Domino's, Hardee's, Popeye's, Subway and Bon Appetit already have instructed their suppliers to stop using fluoroquinolones in chicken. Many major medical groups, including the American Medical Association and the Infectious Disease Society of America, have publicly supported banning fluoroquinolone use in poultry.

Source: PRNewswire - 7th September 2005

5m Editor