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US Senate Supports Human-Relevant Research with FDA Modernisation Act

The US Senate has unanimously passed the FDA Modernisation Act, amending outdated regulatory requirements to include modern, human-relevant testing methods like organ-on-a-chip. This significant legislative change aims to reduce reliance on ineffective animal experiments and improve the accuracy of drug development processes. The Act’s potential global impact is expected to encourage similar reforms in other countries, including Australia. This milestone marks a crucial step towards more ethical and scientifically valid research practices, reflecting a growing shift towards animal-free methods in medical research.

One of the greatest hurdles to advancing non-animal research methods is regulatory requirements for animal testing. In the US, the Federal Food, Drug, and Cosmetics Act (FFDCA), requires animal tests to be conducted in all new drug applications submitted for regulatory approvals. This legislation has been in urgent need of reform, given the developments in non-animal research methods and inability of animal models to accurately predict human response.

It is therefore a great cause for celebration that the U.S. Senate has unanimously passed the FDA Modernisation Act! The Bill was reintroduced yesterday after exclusion from a broader Act passed the day prior.

The FDA Modernisation Act amends the outmoded regulatory guidance at the FDA by broadening the options for drug developers seeking regulatory approvals to include modern and human-relevant testing method (such as organ-on-a-chip) in lieu of less effective animal experimentation.

There is still some way to go with further negotiations expected between the House and Senate before the Bill receives final approval.

Whilst there is no Act mandating animal testing in Australia, the Therapeutic Goods Administration issues various Australian regulatory guidelines. While animal data is referred to often and appears to be the traditionally accepted method of proof, there does appear to be potential for alternative data to be used in place of animal testing.  In an international drug market, the removal of animal testing requirements by the FDA would have global impact and incentivise the realisation of such potential in Australia. HRA thanks the many individuals, politicians, non-profit organisation and research institutes that have lobbied for this crucial Bill.



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