Company marketed off-label use of NexGard Spectra
Merial Animal Health breached rules in its promotion of NexGard Spectra to the veterinary profession, the National Office of Animal Health (NOAH) has found.
The ruling follows a complaint made by Zoetis UK, which related to the promotion of NexGard Spectra to the veterinary profession via telephone conversations and webinars.
NexGard Spectra claimed in its promotion that it provided protection to dogs against lungworm, which is not indicated in it Summary of Product Characteristics (SPC).
This promotion was on a veterinary practice website, where it was suggested that such a licence was expected to be granted in the future. The information is believed to have come from a Merial company employee.
During a NOAH Code of Practice Committee, members came to the unanimous decision that Merial had been promoting an off-label use of NexGard Spectra, contrary to Code of Practice clauses.
In particular, the Committee took into account that the claim came via an employee of Merial during a webinar, during which the representative wrote: ‘You can use a product that is indicated for lungworm alongside NexGard’.
The Committee said this was indicative of a culture within Merial to suggest that NexGard Spectra could be used against lungworm.
During the committee, chaired by Guy Tritton, Merial’s representatives were asked to say what their response would be if a vet telephoned them about NexGard Spectra’s ability to be used against lungworm.
They explained their response would be and had been that there were studies showing its efficacy for lungworm, but that such use would be off-licence.
After reviewing the collective information, the Committee concluded that Merial was, in substance, promoting off-label use. As such, Merial was also found to have failed short of the high ethical conduct expected of NOAH members, which is required under Clause 11.2.
Full details of the Code of Practice and rulings of the Committee are available at www.noah.co.uk.
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