Monday, 12 September 2022 09:37

NAM developers call for acceptance of new methods in drug development Featured

A group of international companies developing human-on-a-chip technologies has reached out to key members of the U.S. Congress, urging them to support the so-called FDA Modernization Act as part of a legislative package.

The FDA Modernization Act is a bill that would allow researchers to use the best tools available to determine whether drug candidates are safe for humans. And that would certainly not be animal testing, but animal-free methods. However, to date, such animal-free models would be underutilized in drug development, as regulatory agencies focus only on findings obtained with animal models when reviewing new drug candidates.

The signatories point to the unreliability of animal test results, which has led to the deaths of patients despite safe animal test results and the withdrawal of numerous drugs. Of 43 drugs found to have serious toxic effects after regulatory approval, only 19% showed a direct relationship to toxicity in animal studies. The authors, on the other hand, advocate the use of microphysiological systems, organ chips, spheroids, and organoids, which are known for their accuracy and better prediction of toxicity in humans. The bill is only an amendment to a current legislative bill and there is a risk that it will be deleted. This would cement animal testing.

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