FDA no longer requires all drugs to be tested on animals before human trials: NPR
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A new US law removed the requirement that drugs under development be tested on animals before being given to human trial participants.
Animal rights activists have long called for such a move, while some pharmaceutical industry players argue that animal testing can be ineffective and expensive.
Sen. Rand Paul, R-KY, sponsor of the FDA Modernization Act 2.0, said in a statement that the new law would help end “the unnecessary suffering and death of animal test subjects” and “help bring safer and more efficient products to market.” drugs”. Faster by reducing red tape that current science doesn’t support.”
PETA hailed the new law as a “step change” in the development of new drugs and treatments.
The law, which President Biden signed into law in December as part of a major spending package, does not directly ban animal testing of new drugs.
Instead, it waives the requirement that drug companies use animals to test new drugs before human trials. Companies can still test drugs on animals if they want to.
There are many other methods drugmakers use to evaluate new drugs and treatments, such as computer modeling and “organs-on-chips,” thumb-sized microchips that can simulate how pharmaceuticals affect organ function.
But Aliasger Salem, a professor at the University of Iowa College of Pharmacy, told NPR that companies choosing to use these alternative testing methods as a substitute for animal testing should be aware of the limitations of the methods to ensure the safety of their drugs.
“Companies need to be aware of the limitations of these technologies and their ability to detect or identify potential toxicities,” Salem said.
“You don’t want to move to systems that can’t handle all the types of toxicity that have been seen before without making sure that the methods you have in place allow it.”
An FDA spokesperson told NPR that it will “comply with all applicable omnibus regulations and continue to work with stakeholders to encourage the development of alternative test methods.”
This year’s federal budget includes $5 million for a new FDA program to reduce animal testing by helping to develop and encourage industry, the government says. representative.
The National Association for Biomedical Research, which supports animal drug testing, says animal testing, along with human testing, “remains the best way to determine the physiological, neuroanatomical, reproductive, developmental, and cognitive complexity of drugs to determine whether they are safe and effective for the market.” approval”.
The new law amends the US Federal Food, Drug, and Cosmetic Act of 1938.
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