A coalition of animal protection groups has filed a lawsuit in the federal court against the US FDA accusing the agency of violating its duty to find sound alternatives to testing new drugs and medical devices on animals.
The lawsuit, filed under the Administrative Procedure Act, states that the US 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.
The petition was submitted to the US FDA on 14 November 2007 by the Mandatory Alternatives Petition Coalition, a group of US and UK animal protection organisations.
The coalition wants to bring the USA in line with the EU, which, for over two decades has mandated that animal tests may not be used when available non-alternatives exist.
The petition wants the US FDA to instil regulations that would result in pharmaceutical companies, medical device manufacturers and other US FDA-regulated entities to use non-animal testing methods whenever possible.
Coalition Spokesperson Dr Jarrod Bailey said that reliable testing methods are available, with more in development, to produce safer and more effective drugs than current animal methods.
“The US lags behind Europe in ending cruel animal tests when better alternatives are available. The time for action is overdue,” Bailey said.