October 26, 2000
FDA/CVM PROPOSES TO WITHDRAW POULTRY FLUOROQUINOLONES APPROVAL
The Food and Drug Administration’s Center for Veterinary Medicine is proposing to withdraw approval of the new animal drug application (NADA) for use of the fluoroquinolone antimicrobial enrofloxacin in poultry. Therefore, as required by FDA regulations, the Center has issued a notice of opportunity for a hearing on its proposal.
The Office of the Federal Register put the notice on public display October 26, 2000, and plans to publish the notice in the October 31, 2000, Federal Register.
This action is based on the Center’s determinations that:
The use of fluoroquinolones in poultry causes the development of fluoroquinolone-resistant Campylobacter, a pathogen to humans, in poultry;
This fluoroquinolone-resistant Campylobacter is transferred to humans and is a significant cause of the development of fluoroquinolone-resistant Campylobacter infections in humans; and
Fluoroquinolone-resistant Campylobacter infections are a hazard to human health.
The Center is proposing to withdraw the approval for use of enrofloxacin in poultry on the grounds that new evidence shows the product has not been shown to be safe.
The following approval is affected by this notice:
Enrofloxacin. NADA 140-828, Baytril® 3.23% Concentrate Antimicrobial Solution, approved October 4, 1996, for the control of mortality in chickens associated with E. coli organisms and control of mortality in turkeys associated with E. coli and Pasteurella multocida organisms, Bayer Corp., Agriculture Division, Animal Health, Shawnee Mission, KS.
The notice also refers to the approvals of NADAs 141-017 and 141-018 for use of sarafloxacin hydrochloride in poultry. Abbott Laboratories, North Chicago, IL, is the sponsor of these NADAs. NADA 141-017, Sara Flox WSP, was approved August 18, 1995, for the control of mortality in growing turkeys and broiler chickens associated with E. coli organisms. NADA 141-018, Sara Flox Injection, was approved October 12, 1995, for the control of early chick mortality associated with E. coli organisms in chickens and turkeys. The notice states that Abbott Laboratories has requested withdrawal of these NADAs, that by doing so, the company has waived its right to a hearing and therefore, these NADAs are not covered by the notice.
Enrofloxacin belongs to the class of antimicrobial drugs called fluoroquinolones. Fluoroquinolones also are approved for use in humans, and they are considered to be one of the most valuable antimicrobial drug classes available to treat human infections because of their spectrum of activity, safety, and ease of administration. This class of drugs is effective against a wide range of human diseases and is used both in treatment and prophylaxis of bacterial infections in the community and in hospitals. Fluoroquinolones are used routinely by physicians for the treatment of foodborne disease. These diseases have a major public health consequence in the United States.
FDA approved the NADAs for fluoroquinolones for use in poultry in 1995 and 1996. At the time of approval, the Center instituted several strategies intended to prevent or mitigate the development of resistance. However, resistance developed to the fluoroquinolones in Campylobacter, a major foodborne pathogen in humans.
After thoroughly analyzing all the data and evidence, the Center has determined that:
The primary cause of the emergence of domestically acquired fluoroquinolone-resistant Campylobacter infections in humans is the consumption of or contact with contaminated food;
Poultry are a predominant source of campylobacteriosis in humans;
Poultry carrying fluoroquinolone-resistant Campylobacter are the predominant source of fluoroquinolone-resistant campylobacteriosis in humans; and
The administration of fluoroquinolones to chickens leads to development of fluoroquinolone-resistant Campylobacter in chickens.
The Center's conclusions are based on data from the National Antimicrobial Resistance Monitoring System (a national surveillance program operated by the Center in cooperation with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture), published literature, and other sources. The data indicate that the use of fluoroquinolones in poultry is a significant cause of fluoroquinolone-resistant Campylobacter on poultry carcasses, and therefore a significant cause of fluoroquinolone-resistant Campylobacter infections in humans. The Center’s conclusions are supported by data establishing a temporal association between the approvals of these drugs for use in poultry in the United States and the increase in resistant Campylobacter infections in humans.
Fluoroquinolones have been available for human use since 1986 and are commonly prescribed for persons with gastrointestinal illness. Yet resistance to fluoroquinolones did not increase among Campylobacter organisms until 1996 and 1997, soon after the approval and use of these drugs in poultry. Fluoroquinolone-resistant Campylobacter (including C. jejuni) infections in humans had reached 13.6% by 1998 and rose to 17.6% (for C. jejuni alone) in 1999.
Individuals or companies covered by the notice must submit a request for a hearing within 30 days following the publication of the notice of opportunity for a hearing in the Federal Register. Also, they must submit within 60 days following the publication of the notice all data and analysis they are using to base their request for a hearing. Other interested parties may also submit comments on the notice. Requests for a hearing or to appear at a hearing, data, and analysis, and other comments are to be identified with Docket No. 00N-1571 and must be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Refer to the October 31, 2000, Federal Register for the exact dates and other details.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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