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Tell Bayer to Comply with FDA Ban
Urge the Bayer Corporation to comply with the recently upheld FDA proposed ban on use of Baytril—a Cipro-like antibiotic—in poultry production. This latest decision could be a huge victory for public health, but Bayer can continue to undercut FDA’s efforts to reduce the spread of resistant bacteria by appealing the ban further. Urge Bayer to stop fighting the proposed ban, and immediately withdraw Baytril from the market with no further delaying tactics.
| Sample Letter for Campaign |
Subject: Don't appeal the Baytril Decision (Docket # 00N -1571)
Dear [ Decision Maker ] ,
I urge you to stop fighting the proposed ban by the Food and Drug Administration (FDA) on the use of Baytril in treating chickens and turkeys, and immediately withdraw it from the market with no further delaying tactics.
As you know, Baytril is a fluoroquinolone antibiotic, a class of drugs that also includes Cipro. Fluoroquinolones are considered one of the most valuable classes of antibiotic drugs available to physicians because of their effectiveness against a broad range of disease-causing bacteria and relative lack of side effects. Cipro is the antibiotic most often used to treat severe cases of food poisoning caused by bacteria.
FDA showed that use of Baytril in poultry reduces the effectiveness of Cipro in treating Campylobacter, the most common cause of severe bacterial food poisoning. Data from the Centers for Disease Control and Prevention show that resistance to Cipro in Campylobacter in humans has recently risen to 19 percent; when Cipro-like drugs were first approved for use in poultry in 1995, such resistance was negligible. Although you claim that Baytril is critical for poultry production, that argument is undercut by the fact that six top poultry producers have announced that they no longer use these drugs in chickens produced for human consumption. Moreover, major chicken purchasers, including McDonald's, have instructed their suppliers to stop using fluoroquinolones.
Today, nearly four years after the FDA first proposed to ban use of Cipro-like drugs in poultry, rates of Cipro resistance in bacteria that cause severe food poisoning are disturbingly high, and the science linking use of Baytril in poultry to such disease is stronger than ever.
Please show your concern for public health by immediately withdrawing Baytril from the market for use in poultry.
Sincerely,
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Campaign Launched:
March 22, 2004
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On March 16, the U.S. Food and Drug Administration (FDA) Administrative Law Judge upheld the agency’s proposal to ban use of Cipro-like drugs in poultry. The drug in question, trade name “Baytril,” is made by Bayer Corp. and is almost identical to Cipro. Both are members of the fluoroquinolone class of antibiotics. Fluoroquinolones are important antibiotics for humans. They are the first-choice drug for serious cases of food poisoning.
Baytril is given to entire flocks of chickens and turkeys, even if most of the birds aren't sick. FDA showed that use of Baytril in poultry reduces the effectiveness of Cipro in treating Campylobacter, the most common cause of severe bacterial food poisoning. Data from the Centers for Disease Control and Prevention show that resistance to Cipro in Campylobacter in humans has recently risen to 19 percent, starting from negligible levels when Baytril was approved in 1996.
Chicago-based Abbott Laboratories, the only other producer of Cipro-like drugs for poultry, complied with the ban when it was first proposed in October 2000. In contrast, Bayer fought the proposed ban, delaying action for more than three years so far. FDA regulations allow Bayer to appeal the Administrative Law Judge’s decision to the FDA Commissioner, who would then have to review it before affirming or reversing the Administrative Law Judge’s decision. That process could take months or years, during which time Baytril would remain on the market.
Bayer should stop fighting the proposed ban, and immediately withdraw Baytril from the market with no further delaying tactics.
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