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AgVetLink: Number 58, October 2006

Managing Off-label Uses

Virtually every country that has a regulatory control programme for agricultural compounds and veterinary medicines has to address the challenge posed by off-label use of approved products.

Off-label use

‘Off-label use’ refers to the use of a product in a manner and/or on a species of animal or plant that was not assessed and approved when the product was issued its official marketing approval. In New Zealand the official marketing approval is a product registration from the Approvals and ACVM Group of NZFSA or a prescribed exemption from registration. The uses recommended by the registrant of the product and approved by the Group are always provided on the label. Consequently, any use not listed on the label is called an off-label use.

MUMS

Off-label use is sometimes referred to as ‘minor use/minor species’ (MUMS), and many countries address the off-label use challenge by defining what constitutes a minor use and what animals and plants constitute a minor species. They assess the risks posed by each MUMS, giving them individual approvals.

This MUMS approach has not been followed in New Zealand because 95 per cent of the circumstances in which products are used here would fit the criteria used to define a MUMS situation (e.g. by world standards, sheep are a minor species).

New Zealand approach

The ACVM Group addressed the problem by providing a general registration condition that allows off-label uses, provided the user takes proper precautions to avoid breaches in residue standards. In the case of veterinary medicines, the use must confirm, via veterinary advice, that the use is likely to be safe, appropriate, and not cause breaches in residue standards.

Using this general off-label condition has simplified regulatory requirements where so many uses are effective but do not relate to the ones proposed by the registrant and listed on the label.*

However, a recent case involving the use of a plant compound to treat animals has prompted the ACVM Group to consider limiting the scope of the off-label condition. In this case one livestock producer used a plant pesticide to treat ticks in cattle and deer. The product was not assessed for this purpose, so there was no direction in regard to an appropriate withholding period. Non-compliant residues were found in meat from the treated animals and trade in New Zealand animal products was seriously compromised.

Limited scope proposal

The ACVM Group has decided that, even though the person should have known better in this case, it will be necessary to limit the scope of the off-label condition by making a specific statement that the product must not be used in animals. This statement would be imposed on any product that:

• has not been assessed for use in animals; and

• may have negative consequences if it were used in animals.

The ACVM Group’s initial proposal, which it presented to AVMAC, was to impose the following compulsory statement: “This product must not be applied on or administered to an animal”.

Label change

If a compulsory requirement that affects the user of a product is imposed, it must be put on the label. Therefore, implementing the proposal would require a label change for all affected products.

Industry response

The ACVM Group has received initial feedback from the agrichemical industry, via Agcarm, that it does not support the proposal for the following reasons:

1 It should be obvious to any user that if a use is not on the label it must not be approved and, consequently, the product must not be used for that purpose.

2 This change may be followed by others as people fail to take their obligations in regard to off-label uses seriously, resulting in further label changes at significant cost to industry.

The industry has proposed that, if a statement is required, it should be along the lines of “for plant use only”. This would be a parallel to the existing statement for veterinary medicines, which is “for animal use only”. It was also suggested that with all the changes that are occurring in labels, the ACVM Group and ERMA NZ should mount a campaign on reading and understanding labels.

The industry also objected to the fact that there was no consultation on the change. However, this was a misunderstanding because the ACVM Group took the proposal to AVMAC as the first step in its consultation process. The Group always intended to develop the proposal in consultation and to allow an appropriate phase-in period.

The ACVM Group recognises industry’s concerns, appreciates its suggestions, and accepts that there may be alternative means of achieving the desired outcome. However, the Group is adamant that users must be given clear directions about uses that are not permitted. At the same time it is certain that the horticultural, arable and livestock industries in New Zealand would not be able to operate effectively if all off-label uses were prohibited, as suggested by the agrichemical industry.

Suggestions?

MUMS is a serious national and international issue, and NZFSA is determined to develop an effective and practical response to the global challenge for this particular plant compound issue and for off-label use in general. Inquiries, comments and suggestions concerning the ACVM Group’s proposal and its general approach to off-label use would be appreciated and should be sent to:

Warren Hughes, Programme Manager (Approvals and ACVM Standards)

New Zealand Food Safety Authority
PO Box 2835, WELLINGTON

Email: warren.hughes@nzfsa.govt.nz

* It is noted that the agrichemical and veterinary pharmaceutical industries have never supported the existing policy that legitimises most off-label uses, primarily because of the possible impact on their liability for adverse effects that might be caused by off-label use.