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Drug Development Pipeline at Risk

Dear [Lawmaker],

The recent U.S. Fish and Wildlife Service decision to deny permits for non-human primate (NHP) importations is having a critical negative impact on biomedical research. As the American Pandemic Preparedness Plan ramps up to address COVID and other emerging pathogens, this is absolutely the wrong time to be limiting researcher access to NHPs, which are critically important to addressing viral diseases and other indications affecting Americans.

Non-human primates (NHP’s) have been in high demand in recent years, due in part to the focus on biologic drug pipelines as well as the need to use these models in regulatory-required drug safety and efficacy testing.  Because of their close genetic, physiological, and behavioral similarity to humans, NHPs are often the only relevant animal models for critical translational research.

We are currently experiencing a crisis in which 60% of the preclinical non-human primate models critical to this work are being denied permits by the U.S. Fish and Wildlife Service. This disruption will significantly slow the U.S. biopharmaceutical pipeline, stifle scientific advancement, impair research, halt industry-wide economic growth, and deprive patients of potentially life-saving treatments. The gravity of this situation cannot be understated. A sustainable solution to this critical issue is urgently needed for all stakeholders.

I ask that our government work with the industry to find both short-term and long-term solutions to this crisis and ensure the pipeline for lifesaving medical advancements will continue without interruption.

Sincerely,
______

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I am a strong supporter of the essential biomedical research that is being done in our country which yields invaluable data to treat, cure, and prevent virtually all diseases affecting Americans. The work being done by biopharmaceutical companies and research institutions on drug development in the United States is critical not only to preventing the spread of infectious diseases like COVID-19, but also for the development of new innovative treatments for cancer, diabetes, and a number of other diseases currently without effective treatment options.

The recent U.S. Fish and Wildlife Service decision to deny permits for non-human primate (NHP) importations is having a critical negative impact on biomedical research. As the American Pandemic Preparedness Plan ramps up to address COVID and other emerging pathogens, this is absolutely the wrong time to be limiting researcher access to NHPs, which are critically important to addressing viral diseases and other indications affecting Americans.

Non-human primates (NHP’s) have been in high demand in recent years, due in part to the focus on biologic drug pipelines as well as the need to use these models in regulatory-required drug safety and efficacy testing. Because of their close genetic, physiological, and behavioral similarity to humans, NHPs are often the only relevant animal models for critical translational research.

We are currently experiencing a crisis in which 60% of the preclinical non-human primate models critical to this work are being denied permits by the U.S. Fish and Wildlife Service. This disruption will significantly slow the U.S. biopharmaceutical pipeline, stifle scientific advancement, impair research, halt industry-wide economic growth, and deprive patients of potentially life-saving treatments. The gravity of this situation cannot be understated. A sustainable solution to this critical issue is urgently needed for all stakeholders.

I ask that our government work with the industry to find both short-term and long-term solutions to this crisis and ensure the pipeline for lifesaving medical advancements will continue without interruption.