Adverse drug reactions are a very serious problem, causing more than 100,000 deaths in the U.S. each year.

Introduction

The MAP coalition is a network of organizations that advocate for replacement of animal drug testing methods that are inaccurate, unvalidated, immensely cruel, and often dangerous for human health. The coalition members are concerned at 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. Due to the failure of the FDA to adopt and implement such alternative methods in a timely and effective manner, the member organizations of the MAP coalition have come together to petition the FDA to mandate the use of scientifically sound alternatives to the use of animals.

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.

The FDA could be doing much more within its current authority to replace animal tests with superior non-animal methods. We are asking the FDA to assert leadership in advancing drug testing from archaic and unreliable animal methods to scientifically sound and humane methods.

We have recommended several approaches that would be beneficial, including: (a) stronger industry guidances to discourage submission of unnecessary animal test results; (b) standardization of FDA reviewer practices so animal tests are not requested when not required; (c) harmonization of implementation practices with the EU and Japan; (d) development of a FDA policy for the designation and adoption of "scientifically satisfactory" replacement methods; (e) making maximum use of the extensive FDA human drug database to eliminate the perceived need for much animal testing; (f) adoption of more of the available non-animal methods, and; (g) mandatory implementation by companies regulated by the FDA.

For further information on the Mandatory Alternatives Petition, animal testing for drugs and the alternatives read our FAQs.

PDF   Background Q&A for the Mandatory Alternatives Petition


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