Bayer files notice supporting baytril stance

Agriculture Division
John B. Payne
Senior Vice President
To: Colleagues in the Veterinary Sciences and Food Animal Industries As many of you already know, our animal fluoroquinolone product, Baytril®(enrofloxacin) is a vital antimicrobial that eliminates serious bacterial infections in manyanimals – both companion and food-producing. Baytril received FDA approval for poultry in 1996.
We believed the scientific data supporting Baytril would be enough to demonstrate thatthis valuable product should remain on the market. Unfortunately, political sciencethreatens to overshadow investigative science. To set the record straight, we arereaching out to you to help us accomplish two important goals: 1. Dispel myths and raise awareness of the contributions Baytril makes in ensuring a 2. Rally support from you and other colleagues who have medical and scientific needs in keeping Baytril on the market. One particularly disturbing misperception is that the effectiveness of our human fluoro-quinolone, Cipro®, in treating anthrax might be reduced by the use of Baytril in poultry.
This assertion is false, and if perpetuated, has the potential to cause undue public alarm.
The FDA has responded to media inquiries, stating that “it is not aware of any risk ofreduced effectiveness from the use of Cipro to treat human anthrax infections resultingfrom the use of Baytril in poultry.” It is our hope that by clearing the air, we will enable the scientific discussion to moveforward unencumbered by misperception. As you may recall, the FDA asked us inOctober 2000 to voluntarily withdraw Baytril, based in part upon a review of data collected in 1999 under the federal National Antimicrobial Resistance MonitoringSystem (NARMS). The 1999 report suggested a national rise in fluoroquinolone-resistant Campylobacter in humans. We believe that the data do not support CVM’s conclusion that a national trend of rising resistance occurred. Furthermore, our analysisof government NARMS data for 2000 confirms that stance. Bayer CorporationP.O. Box 390Shawnee Mission, KS 66201-0390Phone: 913 268-2750Fax: 913 268-2855 On February 20, the Agency granted Bayer a hearing to present new findings in support of Baytrilfor poultry. This hearing will provide for a thorough, thoughtful review of the science regardingwhether the therapeutic use of Baytril in poultry is a threat to human health. We will also demonstrate that removing Baytril will not reduce fluoroquinolone-resistantCampylobacter in humans and that instead the leading causes of fluoroquinolone-resistantCampylobacter are related to other factors. Finally, we look forward to the opportunity during this process to present the scientific evidencethat substantiates our position that Baytril is not a threat to public health, but in fact, contributesto a safer food supply. Here are highlights of our presentation during the hearing process: - Baytril helps ensure that only healthy chickens enter the food supply. - The 1999 NARMS resistance data are not a valid basis for demonstrating a national increase in fluoroquinolone-resistant Campylobacter nor for removing Baytril from the market. - Removing Baytril from the poultry market will not reduce the level of fluoroquinolone-resistant Campylobacter found in people.
- Safe handling methods, thorough cooking and avoiding biologically unsound water significantly reduces food-borne bacterial infections.
- Baytril is only available by prescription from veterinarians.
- Baytril labeling requires veterinarians only prescribe Baytril for chicken flocks when the health of the entire flock is threatened. This can be up to 30,000 birds.
- Baytril is used to treat a very small percentage of chicken flocks.
- Baytril is not a growth promoter.
- Baytril is not used as a disease preventer.
Help us keep Baytril on the market so it can help you keep America’s food supply the safest inthe world. How? By writing to CVM and adding your support to the docket; by writing letters to the editorsof the newspapers and other periodicals in your areas separating fact from fiction; and by enlist-ing your colleagues to do the same. The science proves the benefits of Baytril. Let’s make sureAmerica continues to reap those benefits.
Dockets Management Branch (HFA-305)Food and Drug Administration5630 Fishers Lane (Room 1061)Rockville, Maryland 20852 John B. PayneSenior Vice PresidentBayer Animal Health BAYER FILES NOTICE SUPPORTING BAYTRIL STANCE;
ASKS U.S. VETERINARIANS TO HELP DISPEL MYTHS
SHAWNEE, Kan., March 21, 2002 -- Bayer Corporation today filed with the U.S. Food and Drug Administration (FDA) a Notice of Participation, the next step toward a hearing where the company will present an analysis of new government data supporting the continued use of Baytril® (enrofloxacin), a vital antibiotic that helps ensure a safe food supply by eliminating serious bacterial infections in poultry. The company today also reached out to the nation’s veterinarian community and food animal industries, asking for help to correct public misperceptions about Baytril. In October 2000, the FDA’s Center for Veterinary Medicine (CVM) proposed the withdrawal of Baytril in part to address concerns about a reported national increase in fluoroquinolone-resistant Campylobacter infections in people during 1999. Based upon a scientific review, Bayer disagreed with CVM’s conclusion about Baytril and requested a hearing to review the science on the issue. On February 20, 2002, the Agency granted Bayer’s request for the hearing. The hearing date has not yet been announced. Bayer Files Notice Supporting Baytril Stance -- 2 “We will demonstrate that the therapeutic use of Baytril in poultry is a benefit to public health, rather than a threat, and we look forward to presenting the evidence," said John B. Payne, Senior Vice President, Bayer Animal Health. “Bayer will also demonstrate that removing Baytril will not reduce antibiotic resistance in humans and that instead the leading causes of fluoroquinolone-resistant Campylobacter are related to other factors. The FDA hearing should provide for a thorough, thoughtful review of the science.” Bayer Dispels Baytril Myths
In a separate effort to dispel publicly held misperceptions about Baytril, Bayer called on America’s veterinarians and food animal industry leadership to help separate fact from fiction. In a letter sent today, Bayer said, “Various false assertions have been put forward in the public that if perpetuated could cause undue alarm.” One recent misperception emerged following the terrorist attacks on America. Despite evidence to the contrary, it was reported that the use of Baytril in poultry might reduce the effectiveness of Cipro® (ciprofloxacin) in treating anthrax exposure in people. “This assertion is false. In fact, the FDA has responded to media inquiries, stating ‘it is not aware of any risk of reduced effectiveness from the use of Cipro to treat human anthrax infections resulting from the use of Baytril in poultry,’” Payne said. “There is also persistent confusion that Baytril is used for growth promotion and preventative treatment of disease in food animals,” he said. “These assertions are not only false, but using Baytril in such a manner is both impractical and inconsistent with the FDA- Bayer Files Notice Supporting Baytril Stance -- 3 Approved by the FDA in 1996, Baytril is a fluoroquinolone antibiotic used by veterinarians to treat chickens with serious bacterial infections, helping ensure only healthy chickens enter the nation’s food supply. Baytril is labeled only for use under the supervision of a veterinarian and is currently used in less than 1 percent of chickens, and only when serious disease is threatening the health of the flock, which can number up to 30,000 Both Cipro and Baytril are antibiotics in the fluoroquinolone class, highly regarded for their effectiveness against bacterial infections in people and animals, respectively. Headquartered in Pittsburgh, Bayer Corporation had sales of $10.1 billion in 2000 and is one of Fortune magazine’s Most Admired Companies. The company employs 23,200 people. It is a member of the worldwide Bayer Group, a $29 billion international health care and chemicals group based in Leverkusen, Germany. The Bayer Group stock is a component of the DAX and is listed on the New York Stock Exchange (ticker symbol: BAY). This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Bayer Files Notice Supporting Baytril Stance -- 4 NOTE TO EDITORS: For a copy of the letter, by John B. Payne, Senior Vice President of Bayer’s Animal Health Division, please visit www.BayerUS.com.

Source: http://www.uspoultry.org/positionpapers/docs/ppbayer.pdf