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Bayer files notice supporting baytril stance
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
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
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 Baytril
for 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:
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.
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.
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®
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
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.
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