By Susan J. Matthees –
FDA has denied a Citizen Petition requesting that FDA require drug and device companies to submit data only from non-animal test methods ("NATMs") whenever NATMs are available. The Citizen Petition was submitted on behalf of the Mandatory Alternatives Petition Coalition (the Coalition) in 2007. In April we reported that the Coalition had sued FDA to force the Agency to substantively respond to the Citizen Petition.
In the denial letter, FDA explained that although the Agency shares the goal of reducing reliance on animal testing, there are currently no suitable non-animal alternatives to the testing necessary for FDA to conclude that a drug or device is safe for human use. However, FDA stated that it intends to publish a draft guidance on the use of NATMs to “aid refinement, reduction and replacement of animal tests whenever feasible by explicitly encouraging sponsors to approach the Agency early in the development process for consultation on the suitability and acceptability of non-animal tests.” FDA also reminded the Coalition that the Agency currently accepts a NATM where the NATM provides information that is equal to the equivalent animal testing method.
FDA responded to each of the Coalition’s five requests in detail, mentioning several times that it “carefully considered” the particular issues. FDA acknowledged that the Coalition is correct that animal testing models sometimes fail to predict safety risks in humans (e.g., Vioxx and HIV protease inhibitors), but explained that testing in animals is still the most reliable method for studying the safety of a drug. FDA also stated several times that the Agency is open to recommendations for reliable NATMs and will consider any new NATMs that could provide data equal to animal testing.