July 12, 2024
For the FDA, non-animal testing methods are the path forward

For the FDA, non-animal testing methods are the path forward

For the FDA, non-animal testing methods are the path forward


When we think about the technique of creating new medicine, we frequently image scientists working with cutting-edge know-how in gleaming laboratories. But there’s a aspect of pharmaceutical research that’s darker, hasn’t modified in many years, and escapes most individuals’s discover: the widespread and infrequently painful testing carried out on animals.

We not too long ago bought a glimpse of that business when Inotiv, one among the largest animal testing corporations in the United States, obtained the largest high quality in historical past for violating the Animal Welfare Act, $11 million, for its merciless and neglectful remedy of 1000’s of beagles being bred to be used in laboratories.   

Despite rising proof that animal research are unreliable predictors of the security and efficacy of prescription drugs in people, the drug business continues to rely closely on animal assessments — partially as a result of corporations imagine it’s legally required by the federal authorities when it’s not. Human well being wants and animal welfare go away no room for complacency on this matter, and we are urging the Food and Drug Administration to chart a brand new course.

In a petition filed final month, our organizations referred to as on the FDA to take concrete steps towards ending pointless animal testing by selling the use of non-animal methods for evaluating the security and effectiveness of recent medicine. These methods are usually sooner, extra predictive of human biology, and far inexpensive than animal assessments, and so they’re getting higher all the time.  

Our petition makes three key requests. First, it asks the company to revise its rules to take away language suggesting that animal assessments are the solely option to show the security and efficacy of recent medicine. This change would make it clear that non-animal methods, corresponding to laptop modeling, cell-based assessments, and “organ chips” that mimic human physiology, can as an alternative be used to judge new medicine. This revision wouldn’t ban animal testing outright however would finish the incorrect notion that such testing is at all times mandatory or superior to different approaches. 

Second, the petition calls on the FDA to subject new steerage highlighting the non-animal testing methods the company at the moment accepts. By clearly spelling out the methods the FDA helps, the company can present a street map for corporations to transition from animal research to extra humane and scientifically sound approaches. 

Finally, the petition asks the FDA to include language into all its present and future steerage paperwork highlighting the availability and acceptability of non-animal methods. By integrating its endorsement of non-animal methods into all its communications with business, the FDA can ship a robust sign that corporations ought to use such approaches each time attainable. 

These three steps could appear modest, however taken collectively, they might characterize a vital shift in the FDA’s posture away from animal research — one that would have far-reaching results on the way forward for pharmaceutical analysis. By making it clear that non-animal methods are not simply allowed however actively inspired, the FDA can speed up the transition to a extra humane and scientifically rigorous system of drug improvement. 

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The excellent news is that the FDA has mannequin to comply with in pursuing these reforms. In the final three many years, the Environmental Protection Agency has made exceptional progress in lowering animal testing by each the regulated business and the company itself via embracing different methods corresponding to laptop modeling and automatic, high-efficiency screening to judge the security of chemical substances and pesticides. Moreover, the company’s embrace of different methods has spurred innovation in toxicology, and we’re proud to have lobbied in support of federal regulation and appropriations accelerating this science. EPA units a excessive bar for different regulators to comply with.

And comply with it they need to. The FDA now has the probability to develop into a frontrunner in ending animal testing, and our petition offers the company with a path forward. By adopting the smart reforms the petition proposes, the company can sign its conviction that the finish of routine animal testing is on the horizon and spur the improvement of extra humane and efficient drug analysis methods. This is one thing we urgently want, and we’ll all be higher off for it. 

Kitty Block is the president and CEO of the Humane Society of the United States, and Sara Amundson is the chief authorities relations officer for the Humane Society of the United States and the president of the Humane Society Legislative Fund. 



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