Drug Trial Rules Shift Away From Animal Testing — But What’s Next?

Drug Trial Rules Shift Away From Animal Testing --- But What's Next?

(RightWing.org) – Over the last 100 years, medical breakthroughs have saved the lives of countless people who once faced death over something as simple as an infected cut. Now, modern medical testing is exploring all kinds of potential cures. Still, to ensure the safety of medicines, pharmaceutical companies were required by law to test experimental drugs on animals before administering them to humans.

The practice of animal testing may be dwindling as technological alternatives evolve. In December, President Joe Biden signed the FDA Modernization Act 2.0 into law. It states the Food and Drug Administration (FDA) no longer has to require animal testing before it gives approval to drugs for human clinical trials.

Drug Trials Could Shift From Animal Testing

For a drug to gain approval in the US, the FDA normally requires a toxicity test on one rodent species and one non-rodent species, such as a dog or monkey. In September 2022, Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) introduced the proposal, and both called the practice inhumane and inefficient. The proposed law passed the upper chamber with unanimous consent. Three months later, the president signed it into law as part of the Consolidated Appropriations Act. The move updated the US Federal Food, Drug, and Cosmetic Act, initially enacted in 1938. The new measure eliminating medication testing requirements on animals comes as public sentiment against the practice has grown.

On Friday, January 6, Paul released a statement praising the new law as a means to help end the “needless suffering and death of animal test subjects.” He added it would bring “…safer, more effective drugs to market more quickly by cutting red tape that is not supported by current science.”

While the measure allows the FDA to approve drugs not used in animal testing, what it ultimately does is lift a requirement for pharmaceutical companies to use drugs on animals before humans.

Animal rights groups hailed the legislation, but not everyone agreed. CEO of Understanding Animal Research, Wendy Jarrett, said the use of non-animal testing can’t always detect how a medicine could harm a human being. She noted scientists could test a drug on liver cells and see if it doesn’t damage them. Yet, Jarrett stated it couldn’t detect other issues such as intestinal or brain damage or allergies to the medication.

What’s Next?

It’s not clear if the law will change much because it still allows pharmaceutical companies to test drugs on animals to ensure safety before humans receive them. Some say non-animal testing technologies are in their infancy and may not replace animal testing for years.

Still, drugmakers use many other means to assess the safety of drugs or treatments. Among them are computer models and microchip implants that mimic organ functions. Many hope the law will serve as the next step in ending the suffering and death of animals used as subjects in clinical drug tests.

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