U.S - FDA Requisites No Animal Testing – 2023

United States
March 15, 2024

For the first time in more than 80 hears, a change in the United States law allows new drugs to be tested using modern, animal free, human based methods.

The U.S. Food and Drug Administration (FDA) no longer requires new drugs to be tested on animals before being approved. The agency now has the option to approve drugs that are tested in only non-animal studies, including those that use lab-grown tissues or computer models, before being tested in clinical trials with humans. Previously, the FDA typically required drugs be tested in one rodent and one non rodent species, before they were moved into human trials. But more than 90% of drugs that pass initial animal being unsafe or ineffective in humans. A large amount of data clearly demonstrates the failure of the outdated system based on animal testing. On average, 92% of drug candidates that successfully pass all animal tests are later abandoned during human clinical trials, mainly because they do not work or cause significant side effects."

The new law, signed by U.S. President Joe Biden at the end of December 2022, allows the U.S. Food and Drug Administration (FDA) to approve new drugs without requiring animal data. Previously, pharmaceutical companies were required by law to test the safety and efficacy of their drug candidates in multiple animal studies, including toxicity tests on one rodent species such as a mouse or rat, and one nonrodent species such as a monkey or dog, before testing the drug candidates in human clinical trials.

S. 5002 – FDA Modernization Act 2.0 ( 117th Congress 2021-2022): This bill authorizes the use of certain alternatives to animal testing, including cell-based assays and computer models, to obtain an exemption from the Food and Drug Administration to investigate the safety and effectiveness of a drug. The bill also removes a requirement to use animal studies as part of the process to obtain a license for a biological product that is biosimilar or interchangeable with another biological product.

However, animal testing is not banned under the new law and is still allowed as a possible testing approach. Nevertheless, it is a huge step forward that pharmaceutical companies will no longer be legally obliged to conduct animal tests, and will befree to use accurate, human-relevant, non-animal methods.

While the U.S. is introducing this modern, forward-looking legislation, some animal testing is still required by law for drug approval in the EU.

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