The Mandatory Alternatives Petition seeks to change the way drug testing is done in laboratories before drugs are tested on people. The MAP asks the FDA to mandate the use of scientifically proven drug testing methods that replace the use of animals. These methods are more predictive and reliable than animal testing.
In 2010, the FDA stated that they intend to issue guidance on the use of non-animal testing methods. However, despite repeated meetings and MAP supplemental submissions from NEAVS and other organizations, the agency has not issued guidance or mandated the use of superior alternatives to animal testing.
Subject: Please Promote Alternatives to Animal Testing in FDA Regulations
Dear Ms. Abram and Ms. Fitzpatrick,
I am concerned about the use of animal drug-testing methods that are inaccurate, unvalidated, immensely cruel, and often dangerous for human health. I am also concerned about the number of hazardous drugs approved for human use, the harm they're causing millions of people around the world, and the inability of animal testing methods to detect and prevent these serious consequences.
More reliable testing methods are available, and many more are in development, which can produce safer and more effective drugs than current animal testing methods. Europe is ahead of the U.S. in replacing animal tests with better methods. It is the law in the EU that animal tests may not be used when validated non-animal alternatives are available. We have no such law in the U.S., but the FDA has the authority to accomplish much the same thing in the areas of drug and device testing.
As a concerned citizen, I urge you to do all that you can within your current authority to replace animal tests with superior non-animal methods. I hope that you will assert leadership in advancing drug testing from archaic and unreliable animal methods to scientifically sound and humane methods by mandating the use of alternatives by companies regulated by the FDA. Thank you.
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