Regulatory Brief

 Veterinary Feed Directive - DRAFT TEXT


Formal Title: [Docket Number FDA-2010-N-0155] Veterinary Feed Directive: Draft Text for Proposed Regulation

Brief Description:

The Food and Drug Administration (FDA) is announcing the availability of draft text for a proposed regulation intended to improve the efficiency of FDA's Veterinary Feed Directive (VFD) program. The Agency is making this draft text for a proposal available because of the complex scientific and regulatory issues involved, and because of the potential impact that changes to the VFD regulations may have on stakeholders. The Agency invites the public to submit comments with questions and concerns about the draft text for a proposed regulation.

AVMA Response:

The AVMA applauds the recognition by the US Food and Drug Administration (FDA) of the complex scientific and regulatory issues involved in the changes to the veterinary feed directive (VFD) regulations and the potential impacts they may have on stakeholders.

The VFD is intended to serve as the primary vehicle by which veterinary oversight of antimicrobials in feed will be implemented, a concept supported by the AVMA for the promotion of both animal health and public health.

Our membership has a strong, vested interest in ensuring that the VFD regulations be an efficient and appropriate mechanism for veterinary use of antimicrobials in livestock and poultry. The FDA’s acknowledgement of the necessity to update and streamline the existing requirements related to the distribution and use of VFD drugs in order to facilitate the transition of certain new animal drug products from over-the-counter status to a status that requires veterinary oversight is commendable.

The AVMA is supportive of drug approvals with a flexible dose range for VFD drugs used for treatment, control, or prevention of specific diseases. We believe that veterinarians should be afforded professional discretion in selecting VFD drug dosage within a given range, to allow for more judicious therapeutic use of antimicrobials in certain situations.

Furthermore, the AVMA also encourages prioritization of education of veterinarians, producers, and feed suppliers to ensure compliance at all levels. Due to a long history of antimicrobial feed additives being available over the counter, it is imperative that an action plan be established to ensure that all stakeholders are educated on the regulations regarding appropriate use of a VFD drug.

Background Documents:

April 13, 2012 Federal Register Notice

July 9, 2012 AVMA Comments

Relevant AVMA Policy

Link to Previous Comments