WASHINGTON and LONDON, April 6 A coalition of animal protection groups today filed a lawsuit in federal court against the Food and Drug Administration (FDA) accusing the agency of violating its duty under the Administrative Procedure Act. The lawsuit states that the FDA failed to act on a petition asking the agency to require the use of scientifically sound alternatives to the use of animals in testing to gain approval for drugs and medical devices.
The petition was submitted to the FDA on November 14, 2007 by the Mandatory Alternatives Petition Coalition, a group of U.S. and U.K. based animal protection organizations. The effort would bring the U.S. in line with the European Union, which for over two decades has required that animal tests may not be used when available non-animal alternatives exist. The petition asks the FDA to promulgate regulations that would result in pharmaceutical companies, medical device manufacturers, and other entities regulated by the FDA to utilize non-animal testing methods, whenever such scientifically satisfactory methods are available, to comply with their obligations to demonstrate product safety and efficacy.
The Coalition wants to see the replacement of inaccurate, unvalidated, unreliable and cruel animal tests with scientifically sound and humane methods. It is also concerned about the number of hazardous drugs approved for human use, the harm they cause to millions of people and the inability of animal testing to detect and prevent these serious consequences.
Coalition Spokesperson, Geneticist, Dr. Jarrod Bailey notes: "Many reliable testing methods are available, with more in development, which can produce safer and more effective drugs than current animal methods. It is urgent that the FDA demonstrates the leadership required to adopt modern, humane testing methods. The U.S. lags behind Europe in ending cruel animal tests when better alternatives are available. The time for action is overdue."
Members of the MAP Coalition include the American Fund for Alternatives to Animal Research (AFAAR); British Union for the Abolition of Vivisection (BUAV); In Defense of Animals (IDA); and the New England Anti-Vivisection Society (NEAVS). The petition was supported by other animal protection groups, as well as physicians, scientists, veterinarians, professors, and individuals interested in reducing unnecessary animal testing. The Coalition is represented by Katherine Meyer of the public interest law firm Meyer Glitzenstein & Crystal.
NOTE TO EDITORS: Dr. Jarrod Bailey is available for interview.
SOURCE MAP Coalition