Opinion: Finding cures faster: Bring the FDA into the 21st century with advanced testing

From every sector, the cry is being raised: “We can’t go back to the way things were before the pandemic.” CEOs and politicians, educators and entrepreneurs, health professionals and scientists, all urge the importance of taking stock, adjusting, and learning. One sector in which this must happen now is drug development, where an 83-year-old rule requiring that drugs be tested in animals impedes the development of life-saving medicines.

The 1938 Federal Food, Drug, and Cosmetic Act requires that every drug be tested on animals — even though more than 90% of drugs found to be safe and effective in animals fail during human clinical trials, and even though safer and more effective methods of drug testing have been developed since then.

If Robert Califf, the new director of the Food and Drug Administration, and a bipartisan group in Congress follow through on their promises, the animal testing requirement could be history.


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

The FDA Modernization Act of 2021, initially introduced in the House of Representatives and later in the Senate, is supported by a bipartisan group of lawmakers that include Reps. Vern Buchanan (R-Fla.) and Elaine Luria (D-Va.) and Sens. Paul and Cory Booker (D-N.J.). This act would allow companies to use methods more advanced than animal testing to examine a drug’s safety and effectiveness.


The issue of requiring animal testing isn’t limited to the west side of the Atlantic. 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-based assays, organ chip systems, computer modeling, and the like — are already a trusted part of the research establishment and are proving to be more effective than animal testing in predicting whether drugs will work and be safe in humans.

The delay in development and bringing new drugs to market caused by animal testing aren’t just theoretical. Cyclosporine, a drug now widely and successfully used to treat autoimmune disorders and prevent organ transplant rejection, was delayed because it failed in animal testing. No one really knows how many drugs have been rejected for failing animal tests that may have proven to be safe and life-saving for humans.

The development of vaccines for Covid-19 provides a powerful example of how using alternative methods can speed development. It took just 63 days from the time the sequence of the virus was made known to a human volunteer getting the first vaccine dose.

The rules were relaxed to speed along a process that normally takes 10 to 15 years, part of which is taken up with animal testing. Even so, vaccine developers were required to do animal testing concurrently to follow the law, though perhaps unnecessarily.

To be clear, the FDA Modernization Act neither limits nor forbids animal testing. Instead, it merely lifts the requirement for animal testing, which lets the FDA authorize the best testing methods — animal or non-animal — to determine the safety and effectiveness of new drugs and vaccines. It allows research to move forward with testing that is more relevant to human health than animal testing.

Bioprinted organ models, organ-on-a-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 benefit these methods offer is that they are based on human biology, not mouse or pig or other animal biology.

The use of test methods based on human biology could cut in half the time to market for new drugs and reduce costs as much as five-fold.

During the Covid-19 crisis, government officials and scientists brought urgency to the pandemic response, cut through organizational red tape, and developed successful vaccines in less than a year. The FDA and academic and biopharma researchers cannot, and should not, go back to a pre-pandemic mindset when it comes to 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 cofounder and CEO of the Center for Contemporary Sciences. Both organizations advocate for reduced animal testing.

Source: STAT