FDA finalises transgenic animals guide
pharmafile | January 23, 2009 | News story | Research and Development, Sales and Marketing | FDA, US, reg
The route map for companies wishing to sell medicines made in genetically-engineered animals has been drawn up by the FDA.
The guidance has been 10 years in the making, and comes a few days after an FDA committee recommended a drug that could become the first US-licensed medicine to be produced in a transgenic animal.
GTC Biotherapeutics won the backing of FDA advisors for ATryn, a recombinant antithrombin III made in the milk of genetically-engineered goats. Developed in collaboration with Ovation Pharmaceuticals, the drug is for the prevention of peri-operative and peri-partum thromboembolic events in patients with hereditary antithrombin deficiency.
The FDA's guide covers animals used to manufacture therapeutics, as well as those engineered for other purposes such as disease resistance or increased nutritional value in livestock, or animal models of human disease used in drug discovery.
The document is not a binding set of regulations, but does provide a clear statement of FDA thinking on the development of genetically-modified animals. This should give companies developing transgenic animals for therapeutics production more confidence in the regulatory requirements for bringing products to market.
Dr Randall Lutter, the FDA's deputy commissioner for policy, said the guidance would help the agency "efficiently review applications for products from genetically-engineered animals to ensure their safety and efficacy".
The agency released a draft of the guidance in September last year, and received around 28,000 comments. Concerns about the transparency of the process raised by groups such as the Centre for Science in the Public Interest mean that advisory committee meetings will be held as a matter of course before any generically-engineered animals are approved.
In the guidance, the FDA gives recommendations on the production, processing, containment and transport of genetically-engineered animals, as well as illustrating the information required for a successful new animal drug application (NADA), which is needed to secure the right to produce and keep transgenic animals.
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The FDA's guidance covers the regulation of transgenic animals – specifically those with engineered genes that can be passed onto their offspring.
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