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Ecology and Antibiotics in the News
FDA Bans Use of Enrofloxacin in Poultry
July 28,
2005
The US Food and Drug Administration today announced its final
decision to ban the distribution and use of the antibiotic enrofloxacin
for the treatment of bacterial infections in poultry. Enrofloxacin,
a fluoroquinolone antimicrobial drug in the same class as Ciprofloxacin
('Cipro'), is marketed by Bayer Corporation under the name Baytril.
This significant decision marks the first time that the FDA has
withdrawn approval of an agricultural drug due to concerns about
the human health impact of antibiotic resistance.
The FDA is concerned that use of Baytril in poultry is causing
the emergence of resistant strains of Campylobacter bacteria.
Campylobacter live in the gastrointestinal tract of poultry.
These bacteria, when transmitted to humans, cause food-borne gastrointestinal
infections (i.e. food poisoning), which can lead to complications
such as arthritis and blood infections. Baytril is used extensively
to treat respiratory infections in poultry.
Research, including APUA's
2002 FAAIR Report, which was entered into evidence in the
FDA deliberations, has shown that the use of Baytril in poultry
reduces the effectiveness of Cipro in treating human Campylobacter
infections. According to Centers for Disease Control and Prevention
statistics, resistance to Cipro in Campylobacter causing
human infections increased from negligible amounts in 1995, when
Cipro-like drugs were approved for use in poultry, to 21 percent
in 2002. This increasing proportion of resistant infections represents
a corresponding increase in treatment failure, cost, extended
illness, and mortality.
According to FDA regulations, food from animals that have taken
a certain drug must carry a "reasonable certainty of no harm."
The FDA's determination that poultry treated with Baytril does
not meet this standard led to the decision to withdraw approval
of Baytril for use in poultry.
While the final decision takes effect September 12, 2005, Bayer
Corporation has 60 days to appeal the decision, possibly resulting
in delayed implementation.
For more information please see the following links:
FDA
Final Decision
FDA
Press Release
Keep
Antibiotics Working (KAW) Press Release
HEALTH: FDA Bans
Use of Antibiotic In Poultry, The Wall Street Journal, July 29,
2005
For more information about antimicrobial use and resistance in
agriculture, please see APUA's 2002 FAAIR
Report.
GAO Report Recommends Data Collection on Animal Antimicrobial Use
May 24, 2004
The US General Accounting Office (GAO) today released a new report recommending that USDA, FDA and CDC develop and implement a plan to collect data on antibiotic use in animals. The study, ”Antibiotic Resistance: Federal Agencies Need to Better Focus Efforts to Address Risk to Humans from Antibiotic Use in Animals” (GAO-04-490), also recommends expedited risk assessment for animal antimicrobial drugs deemed critical in human medicine. GAO found that researchers disagree about the extent of the harm to human health from transfer of antimicrobial-resistant bacteria from animals to humans.
The findings of this important study serve to underscore the importance of APUA’s FAAIR II Project, the purpose of which is to foster discussion among a diverse group of expert stakeholders regarding the most effective means for gathering data on animal antimicrobial use in the United States. A comprehensive report of the FAAIR II Project will be released this summer.
Read the GAO report and highlights.
Read press releases about the report from Keep Antibiotics Working and Animal Health Institute.
Judge Rules in Baytril Hearings
March 19, 2004
An administrative law judge today ruled in favor of FDA s proposal to withdraw approval for use of the fluoroquinolone antimicrobial Baytril in poultry due to concerns about increasing resistance in human Campylobacter infections. Closely related to Cipro, Baytril was approved by FDA in 1995 and is currently marketed by Bayer Corporation. Abbot Labs, which formerly manufactured a similar drug, voluntarily withdrew its product in compliance with FDA s initial request in 2000. Bayer is likely to appeal the decision to the FDA Commissioner s office, during which time the drug will remain on the market. Fluoroquinolone drug products are still approved for therapeutic use in cattle, horses, cats and dogs. APUA is pleased to report that the APUA "FAAIR Report" was entered as evidence in the proceedings by CVM.
Read CVM update (with link to the Judge s decision).
For more on the history of the poultry-fluoroquinolone debate, see CVM s excellent and informative website on the issue.
Ecology Program Staff Invited to Attend FAO/OIE/WHO Expert Workshop
December 1-3, 2003
The first Joint FAO/OIE/WHO Expert Workshop on Non-human Antimicrobial Usage and Antimicrobial Resistance was held at WHO Headquarters in Geneva, Switzerland. Dr. Stephen DeVincent, APUA Ecology Program Director, was among the invited participants. The Workshop s purpose was to discuss scientific evidence in order to develop consensus on health aspects of antimicrobial use in veterinary medicine and food animal production. A second joint workshop has been planned for March 2004.
Read final report and background documents.
FDA Releases Final Guidance on Microbial Risk Assessment for Antimicrobial Animal Drugs
October 23, 2003
FDA today released the Final Guidance for Industry (GFI) #152 ("Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern"). The document outlines a qualitative approach to risk assessment with respect to antimicrobial resistance intended to guide decision-making on New Animal Drug Application approvals.
Read Final Guidance #152.
Read APUA Ecology Program Summary and Evaluation of Guidance #152.
McDonald s and Danish Veterinary Institute Honored at 2003 APUA Annual Leadership Award Reception
September 15, 2003
APUA honored McDonald s Corporation and scientists at the Danish Veterinary Institute with its Annual Leadership Award in recognition of their efforts to improve antimicrobial use in food animal production.
Read press release.
WHO Releases Expert Report Evaluating Antimicrobial Growth Promoter Ban in Denmark
August 13, 2003
In November 2002, the World Health Organization convened an independent, multidisciplinary, international expert panel to review the potential consequences to human health, animal health and welfare, environmental impact, animal production, and national economy resulting from Denmark's 1998 ban on antimicrobial growth promoters in food animal production. The Report released today concludes that the Danish experience suggests that antimicrobial growth promoters can be withdrawn without significant expense or health consequences to farm animals.
Read WHO Report.
Preservation of Antibiotics for Medical Treatment Act of 2003 (S. 1460) Introduced in Senate
July 25, 2003
Senator Edward Kennedy (D-MA) today introduced the bipartisan Preservation of Antibiotics for Medical Treatment Act of 2003 (S. 1460). The proposed legislation would withdraw approval for the nontherapeutic use in animals of any drug in the same class as a critical antimicrobial animal drug (defined to include all penicillins, tetracyclines, bacitracins, macrolides, lincomycins, streptogramins, aminoglycosides, sulfonamides, and any other drug or derivative of a drug used or intended for therapeutic or prophylactic use in humans) unless specifically exempted by FDA. Co-sponsors include Senators Jeff Bingaman (D-NM), Daniel K. Inouye (D-HI), Mary Landrieu (D-LA), John F. Reed (D-RI), and Olympia J. Snowe (R-ME). A companion bill (H.R. 2932) was also introduced in the house by Rep. Sherrod Brown (D-OH).
Read S. 1460.
Health Canada Releases Expert Report on Use of Antimicrobials in Food Animals
June 27, 2002
An expert committee released the Final Report of the Advisory Committee on Animal Uses of Antimicrobials and Impact on Resistance and Human Health. Recommendations in the report include increased restrictions on antimicrobial use by Canadian farmers, import restrictions, and increased surveillance of use and resistance.
Read the Health Canada Expert Report.
McDonald s Corporation Announces Global Policy on Antibiotic Use in Food Animals
June 19, 2003
McDonald s Corporation today announced a new Global Policy that requires direct meat suppliers to phase out use for animal growth promotion of antibiotics also used in human medicine. Suppliers are also required to comply with a set of Guiding Principles for Sustainable Use.
Read the McDonald s Global Policy.
New England Journal of Medicine Publishes Editorial on Antimicrobial Use in Animals
October 18, 2001
The latest issue of the New England Journal of Medicine contains three articles related to antimicrobial use and resistance in food animals. The articles are accompanied by an editorial by Dr. Sherwood Gorbach, FAAIR Project Co-chair, entitled Antimicrobial Use in Animal Feed-Time to Stop.
Click here for abstracts and more information.
AMA Recommends Restricting Antibiotic Use in Animals
June 2001
At its 2001 Annual Meeting, the policy-making branch of the American Medical Association (AMA) adopted Resolution 508, which opposes the sub therapeutic uses of antimicrobials in animal agriculture and calls for regulations to support this stance.
Read the AMA Resolution 508.
Read a response from the Animal Health Institute.
APUA FAAIR Report
May 9, 2001
The comprehensive report of an expert committee coordinated by APUA was published today as a Supplement to Clinical Infectious Diseases. The report considers ecological and human health consequences of antimicrobial use in food animal production and plant agriculture.
See the FAAIR Project page for more information.
Representative Brown (D-OH) Introduces The Antibiotic Resistance Act of 2001
May 9, 2001
On May 9, Rep. Sherrod Brown, (D-OH) introduced H.R. 1771, also known as the Antibiotic Resistance Act of 2001. This bill seeks funding for the Department of Health and Human Services (DHHS) to implement the priority items in the Federal Government's Interagency Action Plan, adopted in January 2001.
Read proposed legislation.
US Interagency Task Force Releases Public Health Action Plan to Combat Antimicrobial Resistance
Jan. 18, 2001
The US Department of Health and Human Services released its Interagency Action Plan for fighting antimicrobial resistance. The Action Plan sets priorities and deadlines for ten US agencies and departments in the following areas: 1) surveillance, 2) prevention and control, 3) research, and 4) product development. These four areas contain 84 action items, including 13 priority action steps considered essential to addressing antimicrobial resistance. Of these 13 priorities, seven are already underway, and six are planned to begin within the next one to two years.
Read Interagency Task Force Plan.
World Health Organization Consultation
June 5-9, 2000
Held in Geneva, this groundbreaking Consultation focused on the public and human health aspects of antimicrobial use in animals intended for food while recognizing the ongoing need for antimicrobial treatment of diseased animals. APUA was one of 16 participating organizations. The primary product was the WHO Global Principles for the Containment of Antimicrobial Resistance in Animals Intended for Food.
Read the WHO Global Principles.
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