The FDA Modernization Act Will Provide an Essential Re-Set of Our Broken Drug Development Programs in the United States

Please tell your legislators to support the FDA Modernization Act here.

Congress has three fundamental responsibilities: pass new legislation, fund the implementation and enforcement of the enacted laws, and establish taxes to pay for them. And that’s the sequence: authorize programs and then implement them. 

For instance, Animal Wellness Action (AWA) worked to ban animal fighting on every inch of U.S. soil. Since that happened, we’ve stepped up our efforts to fund law enforcement agencies to crack down on fighting.  That’s how the process works.

We are mindful of this sequencing of Congressional action when it comes to animal testing.

Last week, the Biden Administration released a massive $5 trillion budget for the operations of the federal government for Fiscal Year 2023, triggering the start of the annual appropriations cycle that Congress turns to in earnest for at least the next six months.

Within that massive, every-agency funding framework, the U.S. Food and Drug Administration (FDA) has requested a 34-percent budget increase for 2023, seeking bigger investments in public health modernization, core food safety and medical product safety programs, and other vital public health infrastructure. We pay special attention to FDA because a Congressional priority for us is the passage of the FDA Modernization Act, which seeks to eliminate an 83-year-old mandate in federal law for extensive animal testing for all new drug development programs.

A tweak in the statutory and regulatory structure could spur dramatic improvements in safety and efficacy testing, better address human ailments and disease, and reduce the toll taken on animals in pre-clinical testing. Every year, there are millions of animals used in drug development tests, including tens of thousands of beagles and non-human primates.

A small item within that multi-billion-dollar FDA budget is the request for $5 million in funding for a strategy for new alternative methods for product testing. FDA plans to create an FDA-wide New Alternatives Program to “reduce animal testing through the development of qualified alternative methods and spur the adoption of methods for regulatory use that can replace, reduce and refine animal testing.” According to the FDA, “new alternative methods have the potential to provide both more timely and more predictive information to accelerate product development and enhance emergency preparedness.”

It’s a sign of the progress we are making on the FDA Modernization Act that FDA is requesting this funding.  We want to pass the FDA Modernization Act this year, so that the funds for alternatives development are in place when the law is enacted. 

The truth is, private industry and other federal agencies have been hard at work on alternatives, such as microphysiological systems (e.g., liver-on-a-chip or kidney-on-a-chip), artificial intelligence, advanced computing, and cell-based assays. Many are ready for prime time in our U.S. drug-testing protocols. 

But to unleash the full potential of our non-animal methods, the Federal Food Drug and Cosmetics Act (FFDCA) of 1938 must be amended. That’s precisely the purpose of the FDA Modernization Act. Once that law is enacted, we’ll see even more R&D from the federal government, biotech, and the pharmaceutical industry to ramp up alternatives.

What we do know now is that there are viable alternatives and that the current animal-testing paradigm is broken. A re-set is badly needed.

  • Between 90 and 95 percent of drugs found safe in nonclinical tests fail during human clinical trials. Use of modern test methods would improve results and lower attrition rates.
  • It takes an average of 10 to 15 years to bring a new drug to market at the cost of  $1 billion to $6 billion. This delays treatments to patients in desperate need. And given the enormous capital costs built into the process, medical problems that do not affect millions of people may not get the attention of drug makers. Under this very expensive experimental drug system, the drug makers simply cannot recoup the money.
  • Estimates suggest that animal testing is 1.5- to 30-times more expensive than in vitro non-animal models.

We can apply human biology-based test methods to better predict how humans will respond to drugs in clinical trials. “The use of animal models for therapeutic development and target validation is time consuming, costly, and may not accurately predict efficacy in humans,” said Dr. Francis Collins, the long-time director of the National Institutes of Health, the largest research organization in the world. “With earlier and more rigorous target validation in human tissues, it may be justifiable to skip the animal model assessment of efficacy altogether.”

We are already on the verge of the next phase of modern drug development, and allowing for the use of only-animal models doesn’t reflect 21st Century scientific advancement. H.R. 2565 and S. 2952 will be catalysts for this transition to modern science.

The range of organizations – more than a dozen biotech and pharma companies, dozens of patient advocacy and medical organizations, and a long list of animal welfare groups – collectively attest to the resonance of the prescribed reforms.

It’s time for FDA to update its Depression-era regulations and requirements for animal tests and to allow for nonclinical test models that are predictive of what will happen in humans in clinical trials. It’s time for Congress and the FDA to unleash the power of science in overseeing U.S. drug development and to shed archaic, inaccurate strategies in one of the most important pathways for progress in our American health systems.