FDA Approves Alternative to Animal Testing for Botox
The healthcare company Allergan has received approval from the Food and Drug Administration (FDA) for its in-vitro, cell-based assay for testing its own brand BOTOX® (onabotulinumtoxinA) and BOTOX Cosmetic, which the company estimates will lead to a 95% reduction in animal tests over the next three years.
Organizations including the British Union of Abolition of Vivisection (BUAV) and the European Coalition to End Animal Experiments (ECEAE) are applauding Allergan’s announcement after working hard campaigning to end the use of animals in botox tests.
“We welcome this latest development. It is totally unacceptable that animals should continue to pay for our vanity by suffering and dying in these horrendous tests,” said BUAV Chief Executive, Michelle Thew.
The new assay will be put into effect immediately to test the stability and potency of its product. According to Allergen, “the new assay is the first to be developed and approved for any botulinum neurotoxin currently available worldwide, and is specifically applicable to Allergan’s botulinum toxin type A product.”
“We are proud to have achieved this major scientific milestone in the development of a safe and effective alternative test capable of eliminating the need for an animal-based assay for BOTOX®,” said Scott Whitcup, M.D., Allergan’s Executive Vice President, Research and Development and Chief Scientific Officer.
The production of botox currently requires the use of the LD50 test, where thousands of mice are subjected to the drug every year. A recent investigation by BUAV of Wickham Laboratories in the UK uncovered their use of approximately 74,000 mice to test their product Dysport annually, despite having a valid alternative available.
The mice are injected into the abdomen with the botox and then watched. They then typically become paralysed, eventually gasping for breath and if they’re not killed, they will suffocate to death. The ones who don’t die, are gassed or have their necks broken with a pen, which often resulted in breaking backs, instead of killing them (see video).
BUAV will continue to work to get more companies to adopt non-animal alternatives, including Ipsen and Merz-Pharma, in addition to calling on the European Medicines Agency to accept the new alternative for all botox products.
Photo Credit: Steven Beger Photography