Home Systems biology FDA’s 83-year-old animal testing rule needs an update

FDA’s 83-year-old animal testing rule needs an update

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FIn all sectors, the cry is rising: “We cannot return to the way we were before the pandemic. CEOs and politicians, educators and entrepreneurs, medical professionals and scientists all stress the importance of taking stock, adapting and learning. One area where this needs to happen now is drug development, where an 83-year-old rule requiring drugs to be tested on animals is hampering the development of life-saving drugs.

The Federal Food, Drug, and Cosmetic Act of 1938 requires that every drug be tested on animals — even if more than 90% drugs that have been shown to be safe and effective in animals are failing in human clinical trials, and even safer and more effective drug screening methods have since been developed.

If Robert Califf, the new director of the Food and Drug Administration, and a bipartisan group in Congress keep their promises, requiring animal testing could be a thing of the past.

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In response to a written “question for the record” submitted by Sen. Rand Paul (R-Ky.) during Califf’s confirmation hearing, the then-candidate wrote, “We are entering a new era of systems biology with computational methods that enable a more efficient preclinical and clinical development and evaluation approach to drug and device development. I support the shift to the use of non-animal methods where scientifically backed and, if confirmed, would help ensure that the Agency continues its strong commitment to supporting the 3Rs: replace, reduce and refine the use animals in studies. »

The FDA Modernization Act of 2021, originally introduced in the House of Representatives and later in the Senate, is backed by a bipartisan group of lawmakers that includes Rep. Vern Buchanan (R-Fla.) and Elaine Luria (D-Va.) and Sens. Paul and Cory Booker (DN.J.). This law would allow companies to use more advanced methods than animal testing to examine the safety and effectiveness of a drug.

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The issue of requiring animal testing is not limited to the Atlantic west coast. The European Parliament adopted a resolution in 2021 – by a vote of 667 to 4 – to phase out animal testing.

Many alternatives to animal testing – cell testing, organ chip systems, computer modeling, etc. – are already an integral part of the research establishment and prove to be more effective than animal testing to predict whether drugs will work and be safe for humans.

The delay in the development and marketing of new drugs caused by animal testing is not just theoretical. Cyclosporine, a drug now widely used with success to treat autoimmune diseases and prevent organ transplant rejection, has been delayed because it failed in animal testing. No one really knows how many drugs have been rejected for failing animal tests that may have been shown to be safe and life-saving for humans.

Vaccine development for Covid-19 provides a powerful example of how using alternative methods can speed up development. It took only 63 days from the moment the sequence of the virus was revealed to a human volunteer receiving the first dose of vaccine.

The rules have been relaxed to speed up a process that normally takes 10 to 15 years, part of which is devoted to animal testing. Even so, vaccine developers were necessary for doing animal testing at the same time to comply with the law, but perhaps unnecessarily.

To be clear, the FDA Modernization Act does not limit or prohibit animal testing. Instead, it simply waives the animal testing requirement, allowing the FDA to authorize the best testing methods — animal or non-animal — to determine the safety and efficacy of new drugs and vaccines. . This allows research to move forward with tests that are more relevant to human health than animal tests.

Bio-printed organ models, organ on chip models, “virtual humans” advances in stem cells, and artificial intelligence applications have been developed to predict human responses to new drugs more accurately and more quickly. The advantage of these methods is that they are based on human biologyno mice or pigs or other animal biology.

Using testing methods based on human biology could halve the time to market for new drugs and reduce costs up to five times.

During the Covid-19 crisis, government officials and scientists made the response to the pandemic urgent, cut red tape and developed effective vaccines in less than a year. The FDA and academic and biopharmaceutical researchers cannot and should not return to a pre-pandemic mindset in medicine and research.

Gary K. Michelson is an orthopedic surgeon and founder and co-chair of the Michelson Medical Research Foundation and the Michelson Center for Public Policy. Aysha Akhtar is a neurologist, preventive medicine/public health specialist, and co-founder and CEO of the Center for Contemporary Sciences. Both organizations advocate for a reduction in animal testing.