The Food and Drug Administration (FDA) on Dec. 11 published proposed regulations that would change the agency’s current so-called veterinary feed directive (VFD) process to provide for enhanced veterinary oversight over a wider range of certain antibiotics used in food-producing animals.
The proposal reflects many of the changes to the VFD process recommended previously to FDA by the NGFA. The proposed regulation is a key part of FDA’s overall plan to provide for increased veterinary oversight of the use of antimicrobial drugs used in food-producing animals that also are medically important for treating human illness. The agency long has expressed concern that overuse of antimicrobial drugs in human medicine, as well as alleged injudicious use in food-producing animals, have contributed to the emergence of resistance to such products when used to treat human illness.
The proposed VFD regulation, which is open for public comment until March 12, would revise the requirements that veterinarians are to follow when authorizing the use of certain animal drugs in feed, including: 1) reducing the record-retention period for VFDs and associated documents from the current two years to one year; 2) deleting the requirement that the quantity of feed be specified on the VFD order; 3) eliminating the requirement that the feed distributor receive the original signed VFD within five working days of receipt of the facsimile or other electronic order; 4) removing the reference to the defined valid veterinarian-client-patient relationship that currently is required for a veterinarian to issue a VFD, and replacing it with a more general requirement that the veterinarian provide supervision or oversight of the animals in a manner that is in conformance with the applicable veterinary licensing and practice requirements; and 5) removing the requirement that all VFD drugs automatically be classified by FDA as category II drugs.
In conjunction with the proposed VFD regulation, FDA also announced the availability of a final guidance document for industry that advises animal drug companies on how to: 1) voluntarily remove growth-promotion use claims for antibiotics from their FDA-approved product labels; 2) add, where appropriate, scientifically-supported disease- prevention, control and treatment uses; and 3) change the marketing status of such drug products to include veterinary oversight.
Within the guidance document, FDA states that it is “currently pursuing a strategy for the voluntary adoption of these changes in an effort to minimize the impacts and provide for an orderly transition.” However, FDA adds that it anticipates animal drug companies should be able to complete the changes within the next three years. Further, FDA states that if adequate progress has not been made during the three-year period, the agency will consider whether further action under the existing provisions of the Food Drug and Cosmetic Act may be appropriate.
The NGFA’s Feed Legislative and Regulatory Affairs Committee will be taking the lead in developing NGFA’s response to the proposed VFD regulation. Members with questions about the proposed regulation or FDA’s guidance document may contact Vice President of Feed Services David Fairfield at (712) 243-4035 or at email@example.com.