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

When we imagine the process of developing new drugs, we often picture scientists working with cutting-edge technology in gleaming laboratories. But there's a side of pharmaceutical research that is darker, hasn’t changed in decades, and escapes most people's notice: the widespread and often painful testing conducted on animals .

We recently got a glimpse of that industry when Inotiv, one of the biggest animal testing companies in the United States, received the largest fine in history for violating the Animal Welfare Act, $11 million, for its cruel and neglectful treatment of thousands of beagles being bred for use in laboratories.

Despite growing evidence that animal studies are unreliable predictors of the safety and efficacy of pharmaceuticals in humans, the drug industry continues to rely heavily on animal tests — in part because companies believe it’s legally required by the federal government when it is not. Human health needs and animal welfare leave no room for complacency in this matter, and we are urging the Food and Drug Administration to chart a new course.

In a petition filed last month, our organizations called on the FDA to take concrete steps toward ending unnecessary animal testing by promoting the use of non-animal methods for evaluating the safety and effectiveness of new drugs. These methods are typically faster, more predictive of human biology, and much less expensive than animal tests, and they’re getting better all the time.

Our petition makes three key requests. First, it asks the agency to revise its regulations to remove language suggesting that animal tests are the only way to prove the safety and efficacy of new drugs. This change would make it clear that non-animal methods, such as computer modeling, cell-based tests, and "organ chips" that mimic human physiology, can instead be used to evaluate new drugs. This revision would not ban animal testing outright but would end the incorrect notion that such testing is always necessary or superior to other approaches.

Second, the petition calls on the FDA to issue new guidance highlighting the non-animal testing methods the agency currently accepts. By clearly spelling out the methods the FDA supports, the agency can provide a road map for companies to transition from animal studies to more humane and scientifically sound approaches.

Finally, the petition asks the FDA to incorporate language into all its existing and future guidance documents highlighting the availability and acceptability of non-animal methods. By integrating its endorsement of non-animal methods into all its communications with industry, the FDA can send a powerful signal that companies should use such approaches whenever possible.

These three steps may seem modest, but taken together, they would represent a crucial shift in the FDA's posture away from animal studies — one that could have far-reaching effects on the future of pharmaceutical research. By making it clear that non-animal methods are not just allowed but actively encouraged, the FDA can accelerate the transition to a more humane and scientifically rigorous system of drug development.

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The good news is that the FDA has a good model to follow in pursuing these reforms. In the last three decades, the Environmental Protection Agency has made remarkable progress in reducing animal testing by both the regulated industry and the agency itself through embracing alternative methods such as computer modeling and automated, high-efficiency screening to evaluate the safety of chemicals and pesticides. Moreover, the agency's embrace of alternative methods has spurred innovation in toxicology, and we’re proud to have lobbied in support of federal law and appropriations accelerating this science. EPA sets a high bar for other regulators to follow.

And follow it they should. The FDA now has the chance to become a leader in ending animal testing, and our petition provides the agency with a path forward. By adopting the sensible reforms the petition proposes, the agency can signal its conviction that the end of routine animal testing is on the horizon and spur the development of more humane and effective drug evaluation methods. This is something we urgently need, and we’ll all be better off for it.

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