Since 1938, the government’s obligation for animal testing in drug research has been a U.S. law. The FDA Modernization Act 2.0, S.5002, was enacted by the United States Senate in September 2022, changing the scene. This legislation was later ratified by the United States Congress in December 2022, ushering in an age in which animal testing in drug development is no longer essential. The measure does not totally prohibit animal experimentation, but it does allow medication makers to explore alternatives when possible. One of these techniques involves simulating human physiology outside of the live system, such as on a chip, in a laboratory, or by using computer simulations to assess how a drug would behave when ingested.
Almost 200 groups support the FDA Modernization Act 2.0. (Notably, generics giant Teva was the only pharma backer). People for the Ethical Treatment of Animals (PETA), one of the law’s most vocal advocates, claimed in a statement that the new regulation heralds a fundamental change in the way medicines are created. The National Institutes of Health (NIH) is urged to discontinue using animals in research projects if it is clear that doing so won’t produce humane cures, according to the group’s own Research Modernization Agreement. Non-animal alternatives testing is the process of evaluating products and offerings in order to ascertain the efficacy and safety of products and ingredients utilised in any industry sector. In-vitro human cell and tissue cultures, organs-on-chips (OOCs), silico models, 3D bio-printing of tissues, synthetic skin replacements, and human volunteer studies are a few examples of non-animal alternative testing methods.
Numerous technologies, including human cell-based assays, organ chips, and micro-physiological systems, as well as advanced computer modeling, have been proposed to enhance or replace animal usage in preclinical investigations. Yet, in the limelight, are these technologies robust enough to convince regulators and the public that a medicine has been thoroughly reviewed and de-risked? The non-animal testing sector is expanding thanks to the assistance of the government and non-governmental organisations. Government agencies uphold rules and regulations, collect donations to support non-animal testing practices such as tests on human volunteers and sophisticated computer modeling approaches, and finance studies involving human volunteers.