White Coat Waste Project has exposed how outdated FDA red tape forces drug makers to torture and kill tens of thousands of dogs—and millions of other animals—each year to fulfill burdensome and useless animal testing regulations.  We’re working with Congress to pass the bipartisan Alternatives to Animals for Regulatory Fairness (AARF) Act to cut this red tape.

Now, a former senior FDA official is calling for reforms, too.  In a new piece at Forbes.com, Dr. David Gortler explains how the FDA’s outdated animal testing rules are harming animals, hurting patients, and stalling medical innovation.

Dr. Gortler is a pharmacologist, pharmacist, and health care policy scholar at the Ethics and Public Policy Center Think Tank in Washington, D.C.  He was a professor of pharmacology and biotechnology at the Yale University School of Medicine, where he also served at Yale’s Bioethicist Center, and was an FDA Medical Officer who was later appointed by the White House to serve on the FDA’s Senior Executive Leadership Team as senior advisor to the FDA Commissioner for drug safety, drug epidemiology, FDA science policy, and FDA regulatory affairs.   

Excerpts of the article below. Read the full article at Forbes.com.

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Most Americans would be appalled to know how many animals are stunned, electro-shocked, sleep-deprived, poisoned, vivisected and killed in the name of science at taxpayer expense. Believe it or not this sort of cruel animal testing is actually required by FDA law.

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Existing FDA regulations allow absolutely no flexibility to explore or implement newer methods that are more predictive for humans because they utilize human biology rather than that of other species.  FDA alone holds the power to initiate change.  In the meantime, companies must follow these regulatory rules in order to move an investigational medication through the review process to obtain FDA approval.  

Beyond regulations, animal tests are enumerated and prioritized in FDA guidance documents.  Guidance documents are meant to be non-binding recommendations that reflect the agency’s thinking on a topic, but do not hold the weight of regulations or force of law …or do they?  Recently, Vanda Pharmaceuticals sought to avoid conducting a 9-month study on dogs, stating the study — which would kill dozens of dogs— had no scientific justification, but FDA reviewers would not budge, referencing its own guidance documents.   

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After 60 years scientists have learned that the results of animal tests aren’t particularly useful or predictive in humans.  Despite this, FDA requires animal tests to be performed for almost every investigational new drug it reviews, regardless of its utility.  It’s noteworthy that approximately 90% of early-phase clinical trials fail after “passing” extensive animal testing.  

The KHA and FDA’s ongoing failure to move away from animal studies has contributed to over tens of million mice and rats killed per year in the name of science in the US.  Separate from that are the other animals killed including, monkeys, rabbits, pigs, guinea pigs, cats.  That includes an estimated 20,000 dogs killed per year.  

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Many of the animal studies required by the FDA are rather nonsensical, including eye- and skin-irritation tests of drugs that are approved only for oral administration.  The National Institutes of Health acknowledges “Approximately 30 percent of promising medications have failed in human clinical trials because they are found to be toxic despite promising preclinical studies in animal models.”  Using animals to test human drugs not only hurts animals, it hurts people.

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America’s FDA deserves a forward-thinking, open-minded, and scientifically nonpartisan generation of leaders who listen to scientific progress, congress, OOC technology and set a positive example against animal cruelty.  In the meantime, animals everywhere will continue to suffer.