March 8, 2001
CVM RESPONDS TO CITIZEN PETITION ON ANTIBIOTICS IN ANIMAL FEEDS
On February 28, 2001, FDA's Center for Veterinary Medicine (CVM) issued a second tentative response to a Citizen Petition that requested that FDA withdraw the approvals for "subtherapeutic" uses of medically important antibiotics in livestock feeds. The petition alleges that the drugs are unsafe when used subtherapeutically because they endanger human health due to selection and transfer of antibiotic resistance that may compromise human therapy. This Citizen Petition (99P-0485/CP) was submitted to FDA on March 9, 1999, on behalf of the Center for Science in the Public Interest (CSPI), the Environmental Defense Fund, the Food Animal Concerns Trust, the Public Citizen’s Health Research Group, and the Union of Concerned Scientists.
In CVM's first tentative response, a letter to CSPI dated August 19, 1999, the Agency explained that because of the complex nature of the action requested, FDA would require additional time to issue a final response to the Citizen Petition. This second tentative response explains further why the Agency cannot yet issue a final response to the petition.
In order for the Agency to withdraw a new animal drug approval, two processes need to be completed. First, CVM needs to determine whether to initiate formal withdrawal proceedings. Second, if CVM decides to initiate formal withdrawal proceedings, it must then undertake the formal withdrawal process required by statute. For legal, scientific, and resource reasons, withdrawal actions for the petitioned drugs need to be considered on a drug by drug basis. Data and information will need to be reviewed and analyzed for each drug. Thus the petitions can only be granted or denied on a drug by drug basis as reviews are completed and resources permit.
An approved new animal drug application can be withdrawn if, among other things, experience or scientific data show that the drug is unsafe, or if the drug is not shown to be safe. If the Center concludes that a drug’s approval should be withdrawn, it is required to provide the drug’s sponsor with notice and an opportunity for a formal administrative hearing (NOOH). A separate NOOH is ordinarily issued for each individual drug, because most of the relevant scientific evidence is likely to be unique to the individual drug, although actions involving chemically related drugs may be consolidated.
Issuance of NOOHs and requests for a hearing are governed by the Federal regulations dealing with formal evidentiary public hearings. A sponsor who requests a formal hearing is required to submit detailed data to justify the request. The request will be reviewed and, if the Commissioner determines that a hearing is justified, the Commissioner will issue a notice of hearing. A presiding officer will conduct a formal evidentiary hearing and render an initial decision, which can be appealed to the Commissioner. A sponsor may appeal the Commissioner’s decision to withdraw an approval of a new animal drug to the U.S. Court of Appeals. The Agency's experience with contested, formal withdrawal proceedings is that the process can consume extensive periods of time and FDA resources.
The Agency recognizes that there are issues related to the role that antimicrobial drug use in food-producing animals plays in the emergence of antimicrobial drug resistant bacteria. To address these issues, the FDA is undertaking an extensive process to evaluate issues related to the use of antimicrobial drugs in both humans and animals, and to develop policies that protect the public health. FDA continues to solicit comments on these issues from interested parties.
The Agency has prepared two documents addressing issues concerning antimicrobial use in food-producing animals. One is Guidance for Industry 78, which addresses how FDA intends to consider the potential human health impact of the microbial effects associated with all uses of antimicrobial new animal drugs in food-producing animals when approving such drugs. The other is a discussion paper, referred to as the "Framework Document," which sets out a conceptual risk-based framework for evaluating the microbial safety of antimicrobial drugs intended for use in food-producing animals. The Framework Document, if implemented, could apply to both drugs being considered for approval and previously approved drugs. Further, as stated in the two documents, the Agency is considering all uses of antimicrobial drugs in food-producing animals.
FDA received comments from more than 38,000 people concerning this Citizen Petition. These comments, as well as other relevant data and information, will have to be evaluated by the Agency before any action will be taken. Therefore, at this time, it would be premature to grant or deny the petition, in whole or in part.
As explained above, the petition can only be granted or denied when the Agency makes a final decision on whether to withdraw any of the drug approvals listed in the petition. FDA will issue a final response to the Citizen Petition upon completion of the Agency's analysis of the comments received on the petition, the Framework Document, numerous consultations, and the resolution of the scientific, legal, and policy issues.
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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