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In 1937, a US pharmaceutical company launched a new sore throat remedy and unwittingly caused a public health disaster. The product, which had not been tested on humans or animals, contained a solvent that proved toxic. More than a hundred people died.
The following year, Congress passed the Federal Food, Drug and Cosmetic Safety Act, requiring drug companies to submit safety data to the Food and Drug Administration (FDA) before selling new drugs. This helped usher in an era of animal toxicity testing.
Now, a new chapter in medicinal drug development may be beginning. The FDA’s Modernization Act 2.0, signed into law late last year, allows drug makers to gather initial safety and efficacy data using new high-tech tools, such as bioengineered organs, organs on chips and even computer models, rather than live animals. Congress also allocated $5 million to the FDA to accelerate the development of alternatives to animal testing.
Read more in Folha de S. Paulo
