Home Department written question – answered at on 4 July 2005.
To ask the Secretary of State for the Home Department what the evidential basis is for the permitted use of the mouse LD50 procedure by themanufacturers of (a) Dysport and (b) Botox; and if he will make a statement.
International and UK regulations relating to the safety and efficacy of medicines require the testing of botulinum toxin products at various stages of their processing, from harvesting through to marketing for use as a prescription-only medicine. The European Pharmacopoeia states that the potency of the toxin as a reconstituted product is determined by an LD50 assay in mice, the reference method, or by a method validated with respect to the LD50 assay. Unfortunately there is at present no accepted and validated alternative to the LD50 test for determining the potency of botulinum toxin at the production stage. The Home Office and all others, including the laboratories and the Medicines and Healthcare products Regulatory Agency, concerned with conducting and regulating such testing are committed to moving to less severe testing procedures as soon as it becomes practicable to do so. The laboratories involved in ensuring that botulinum toxin products are safe for therapeutic use, the only use for which animal tests are licensed, are already gaining expertise in non-animal methods.
Yes0 people think so
No0 people think not
Would you like to ask a question like this yourself? Use our Freedom of Information site.