Formal title: Docket Number [FDA-2010-N-0155] Veterinary Feed Directive; Extension of Comment Period
The AVMA submitted comments regarding the Veterinary Feed Directive (VFD).
The Food and Drug Administration (FDA) extended to August 27, 2010, the comment period for the advance notice of proposed rulemaking (ANPRM) that appeared in the Federal Register of March 29, 2010. In the ANPRM, FDA requested comments on the need for improvements to the VFD regulation. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
As a proponent of the VFD in concept, the AVMA worked with the FDA and other stakeholders to help develop a process that would allow for therapeutic antimicrobial usage. However, while we acknowledge the FDA's intent to protect public health by implementing the VFD process, unintended consequences on animal health and the practice of veterinary medicine could result as VFD drug approvals rise over time. There are critical human capital needs with the veterinary profession, and we underscore the need for a feasible VFD process in order to ensure adequate access to needed therapeutic antimicrobials in order to protect animal and public health. We therefore offer the following enhancements that we assert will relieve burdens currently experienced by practicing veterinarians who must utilize the VFD process to relieve animal pain and suffering.
- Conditions that must be met by veterinarians issuing a VFD
- Veterinarian-Client-Patient Relationship (VCPR) – Any further definition the FDA considers regarding the VCPR's relation to the VFD process should be considered carefully under consultation with the AVMA, as Veterinarian-Client-Patient Relationships (VCPR) can vary across species simply due to the clinical paradigm within which each discipline/species practice exists.
- Flexible Dosing – The AVMA asserts that veterinarians should be afforded the professional opportunity to have flexibility in selecting an applicable VFD drug dosage for prevention, treatment, and control of disease.
- Patient Specification – The AVMA believes that the VFD form should contain several blanks for filling a VFD order for animals housed in multiple barns/geographic locations, to be ordered at the veterinarian's discretion.
- Minor Species Needs – The AVMA recommends revising CFR 558.6(a)(4)(xii) to read "The statement: Extra-label use, (i.e., use of this VFD feed in a manner other than as provided for in the VFD drug approval) is permitted only for minor species in circumstances where medicated feed is the optimal or only reasonable route for drug delivery in the professional judgment of a veterinarian."
- Tonnage Estimate – The AVMA recommends that FDA modify VFD requirements to allow for veterinarians to specify the specific dates during which time the medicated feed will be administered, in lieu of the requirement for total tonnage ordered.
- Submission of VFD Orders – We agree that VFD orders require the same due diligence and oversight by veterinarians as required for prescriptions, but VFD orders should not demand additional paperwork requirements from veterinarians above what is required for prescription drugs. As the FDA considers ways to improve the VFD process, the AVMA encourages the FDA to actively encourage and promote economically viable, user-friendly systems for submission of VFD orders (including electronic means).
- What veterinarians must do with a VFD (e.g., disposition of original VFD and copies)
- Disposition of VFD orders should be modeled after currently existing DEA prescription requirements.
- Records that must be kept related to VFDs
- AVMA asserts that current DEA regulations offer an existing model that FDA could utilize in regards to VFD recordkeeping requirements.
- Cautionary statements required for VFD drugs and animal feeds containing VFD drugs
- The AVMA recommends that VFD refills generally be allowed to be filled over a set amount of time (for example, a set species-specific refill time based on time to market and industry standards) similar to the professional ability veterinarians have in some states to allow for refills for other prescription drugs.
In times of medical need, it is necessary that animals be treated promptly with VFD medications as needed. As the number of Category II feed mills remains low across the United States, and as the numbers of VFD drugs rise, more demand will be placed on those existing Category II mills. VFD drugs could be assigned to Category II or I on a case-by-case basis, in order to help ensure timely access to medications that are needed to relieve animal pain and suffering.
Finally, to enhance the efficiency of the VFD approval process, when considering approval of combination products, the FDA could consider approving only the antimicrobial components of combination drugs as VFD drugs.
Federal Register Notice [Dockets No. FDA-2010-N-0155] (PDF)
The AVMA responded on August 26, 2010. (PDF)
AVMA request to HHS, FDA for expedition of the publication of the draft codified language for the Veterinary Feed Directive (VFD) regulations (PDF)