Tuesday, April 6, 2010

Challenge to FDA’s Delay On Non-animal testing petition

Today we filed a case in federal district court in D.C. against the Food and Drug Administration challenging its unreasonable delay in responding to a November 2007 rulemaking petition by a coalition of animal protection groups called “The Mandatory Alternatives (MAP) Coalition.”  The petition asks the FDA to promulgate regulations that would require manufacturers of drugs and medical devices to use alternative non-animal tests, when feasible, to demonstrate the safety and efficacy of their drugs and medical devices.  Animal tests, which costs millions of dollars, often do not produce valid or otherwise usable data, yet inflict excruciating pain and suffering on their animal subjects.   The requested regulation would bring the U.S. in line with the European Union which since 1986 has required the use of non-animal testing.  Read the Complaint.