BICO Endorses FDA Modernization Act of 2021

BICO, a leading bio convergence company, announced today it is endorsing the bipartisan FDA Modernization Act of 2021. The bill, H.R. 2565 / S.2952, would allow drug and cosmetic makers to develop new products using non-animal models including cell-based assays, organ chips and micro physiological systems, sophisticated computer modeling, and other human biology-based test methods. Since its founding, BICO has been a leader in the effort to end animal testing in the life sciences community, and plan to actively build support for the legislation.

Each year more than 100 million animals are estimated to be experimented on and euthanized for use in biomedical research in the United States alone, according to the Humane Society. This is in large part due to the 1938 Federal Food, Drug, and Cosmetic Act which requires that all new products be tested on animals to ensure safety and efficacy, regardless of if it provides scientific value. More than 80 years later, technological breakthroughs including tissue engineering, single-cell isolation, live-cell imaging and others can be converged to accelerate drug development without the use of animal experimentation.

Human tissue replacement models are undoubtedly a better indicator of toxicity and efficacy than dogs or mice, which share very little physiology to humans,” commented Alex Armento, President of MatTek, a BICO group company. “By giving researchers the choice of testing on animals or human models, we’ll ultimately enable them to make the best decision based on the science.”

There is an ongoing global debate concerning the relevance of animal testing. In September 2021, the European Parliament adopted a resolution calling on the European Commission to establish an action plan to actively phase out animal experiments. This year, Mexico also banned the use of animal testing for cosmetic development while also banning imports of products tested on animals worldwide meaning U.S. developed products forced to test on animals will lose market access.

“There is no bigger ethical issue plaguing the life sciences industry in the United States today than this mandate on animal experimentation,” says Erik Gatenholm, CEO and co-founder of BICO. “Passing this law is not only the right thing to do, but also will advance Health 4.0 and ensure the U.S. continues to be a global life science leader in the coming decades.”

Nearly all BICO’s 13 group companies contribute to advancing drug development including several that provide direct alternatives to animal testing, including:

• CELLINK – 3D bioprinting to fabricate human tissue samples that provide much more physiologically relevant drug testing than animals.
• MatTek – In vitro human tissue models including skin, ocular, oral, respiratory, and intestinal tissue models to replicate toxicity and efficacy of human cells.
• Visikol – In Vitro assays for drug screening and toxicity assessment using high content screening, confocal microscopy, ELISA, and other assays.
• SCIENION – automated precision dispensing that can be used to accurately and reproducible distribute physiologically relevant biological material.
• Cellenion – single large-particle sorting and dispensing technology that enables the handling of complex 3D cellular models such as spheroids and organoids, and that can replace animal testing in pre-clinical research.“

Reference documents:
United States House Bill, H.R 2565 – FDA Modernization Act of 2021
United States Senate Bill, S.2952 – FDA Modernization Act of 2021
Article in the Cambridge Quarterly of Healthcare Ethics “The Flaws and Human Harms of Animal Experimentation”