Center for Food Safety Calls FDA Action “An Outrage” and Demands Transparency in Regulation of Products from Genetically Engineered Animals
Despite claims of cooperation and transparency, the FDA today approved GTC Biotherapeutics’ drug from genetically engineered (GE) goats without holding advisory committee meetings or submitting to a public comment period, a move condemned by the Center for Food Safety. The Center demands action against the FDA’s broad dismissal of public involvement in its approval of GE animals for use in drug development.
“This is truly an outrage,” said Jaydee Hanson, Policy Analyst on cloning and genetics for the Center for Food Safety. “By pushing through approvals of untested GE animals with no thought to health or environmental impact, the FDA is setting us up for widespread disaster.”
The FDA has decided to forgo the advisory meeting on the grounds that GE goats are not intended for human consumption and GTC Biotherapeutics has not requested approval for them as such. However, the Center maintains that this FDA action ignores questions regarding disposal of goat carcasses and whether they will be rendered for use in animal feed, dietary supplements, cosmetics, or fertilizer.
The Center contends that adequate study has not been performed to determine potential environmental impact. Regulations have not been properly outlined to make sure that genetic material from the animal will not find its way out into the wild or human food sources.
“The creation of GE animals is a very slippery slope,” continued Hanson. “All it takes is one mating between an escaped specimen and a natural animal to set off a chain of events that could lead to contamination or extinction. Before we work with any GE animal, we need to first ensure that this cannot and will not happen.”
On January 15, the FDA also announced its final guidance on the regulation of Genetically Engineered Animals, following the original draft guidance released in September 2008. Despite a 60-day public comment period that drew 28,000 responses, the final regulations were relatively unchanged. The Center maintains that the guidance is severely deficient in many areas, most notably, its lack of transparency.
This FDA action comes at a time when the agency is already under fire from lawmakers for pushing through approvals of high-end drugs without adequate safety testing. Concurrently, government officials claim that the agency has delayed approvals on lower-cost medical devices for the handicapped. Opponents to current FDA policy claim that this is further evidence of a corrupt agency that holds corporate interests high above those of the public.
“Normal regulatory process has been ignored and subverted by this FDA and it’s not hard to imagine why,” added Hanson. “We’re hearing the death rattle of a corrupt agency and they’re trying to pass through as many corporate-friendly measures as possible before change can be instituted. We need to make sure these do not stand and that the new administration corrects this culture of corporate pandering.”
Important Safety Information
ATryn is contraindicated in patients with known hypersensitivity to goat and goat milk proteins. Allergic-type hypersensitivity reactions, including anaphylaxis are possible. If these reactions occur during administration, treatment must be discontinued immediately and emergency treatment should be administered.
The anticoagulant effect of drugs that use antithrombin to exert their anticoagulation may be altered when ATryn is added or withdrawn. To avoid excessive or insufficient anticoagulation, coagulation tests suitable for the anticoagulant used (e.g., aPTT and anti-Factor Xa activity) are to be performed regularly, at close intervals, and in particular in the first hours following the start or withdrawal of ATryn. Additionally, patients must be monitored for the occurrence of bleeding or thrombosis in such situations.
The serious adverse reaction that has been reported in clinical studies is hemorrhage (intra-abdominal, hemarthrosis and post procedural). The most common adverse events reported in clinical trials at a frequency of >= 5% are hemorrhage and infusion site reaction.
For more information including full prescribing information go to www.ovationpharma.com.
RECOMBINANT PLASMA PROTEINS