Corporate Statement on Animal Testing
Currently, all pharmaceutical manufacturers are required by the Food and Drug Administration (FDA) in the United States and by other worldwide health regulatory agencies to protect patients and consumers by establishing product safety and efficacy through animal testing and other methods. While we are mandated to conform to these requirements, we take every possible step to minimize animal testing and the animals in our charge receive humane and ethical care, in full compliance with such stringent regulations as the Animal Welfare Act in the United States and similar regulations worldwide.
Allergan shares the pharmaceutical industry's goal of reducing or eliminating animal testing wherever possible, and we are committed to the "3R" principles of refinement, reduction and eventual replacement of laboratory animals in product testing. For instance, for several years we have focused on reducing and refining our assay process used in the final manufacturing stages of BOTOX® (Botulinum Toxin Type A), leading to FDA approval in September 2006 of a revised assay and tightened acceptance criteria for product release that is enabling us to further substantially reduce the number of animals involved in the assay by approximately 50 percent. In the first quarter of 2007, Allergan has submitted two Prior Approval Supplements to the FDA that would further reduce the routine use of animals without decreasing quality assurance.
Industry-wide, great progress has been made — the number of animals used in research has actually decreased over the last two decades. We sincerely look forward to the day when safe and effective alternatives are available and approved by worldwide health care authorities, notwithstanding the fact that it remains mandated by law that at least some animal testing protocols be used to protect the health and safety of patients who depend on vital — and often life-saving — medicines and other products.
At Allergan, we are dedicated to providing safe and effective specialty pharmaceutical products that satisfy unmet medical needs and improve the lives of patients throughout the world.