FDA Modernization Act 2.0

The FDA Modernization Act 2.0 will amend the Federal Food, Drug and Cosmetics Act to eliminate the Depression era requirement that all new drugs go through extensive rounds of animal testing.  In fact, animal testing in at least two species of animals is required by the Food and Drug Administration (FDA).  The FFDCA and FDA regulations specifically require the use of animals, to the exclusion of human biology-based nonclinical methods. These breakthrough discoveries can’t help if they don’t leave the lab.  The vicious cycle of reflexively using antiquated animal models for safety and efficacy must be broken.

S. 5002 is actually two measures – the FDA Modernization Act and the Reducing Animal Testing Act, eliminating archaic mandates for animal testing for all new drugs and biosimilars. This bill will eliminate a Depression-era requirement for animal testing for every new drug being considered for the market. That requirement means every year, tens of thousands of dogs and primates and hundreds of thousands of other animals are tormented in labs, even though animals do not typically forecast the human reaction to drugs. 

Human-relevant cell-based assays, organs-on-a-chip, human-on-a-chip (microphysiological systems), and sophisticated computer modeling have been developed to predict human response more accurately to new drugs, yet the FFDCA does not officially acknowledge these superior test methods.  The FDA Modernization Act 2.0 would change that.

Not only do countless animals endure the torment in laboratories, there’s also a human toll that comes because of an outdated U.S. policy.

A recent study showed that 22 drugs that were approved by FDA for use in patients caused serious liver injury — killing 208 people and requiring liver transplants for 10 more. The point is, our animal-centered screening system fails far more than it works, with sometimes tragic consequences for people.

Contrast that with 21st-century strategies that don’t rely on animal testing. Those same liver-toxic drugs were tested using a liver-on-a-chip model (a non-animal testing method), which showed to be seven to eight times more accurate in detecting the toxicity that killed people. Use of this liver-on-a chip model will not only keep toxic drugs away from people, but it could also generate $3 billion annually for the pharmaceutical industry due to increased R&D productivity.

S. 5002 must now pass the U.S. House, which already has signaled its broad support for modernizing drug testing strategies overseen by the FDA. The House antecedent to this bill, H.R. 2565, introduced by Reps. Buchanan and Luria, with nearly 100 cosponsors, was passed as part of a larger FDA reform measure in June a vote of 392–28. Energy and Commerce Committee Chairman Pallone and Ranking Member McMorris Rodgers backed the measure. 

To improve the drug development paradigm, nonanimal methods must be acknowledged and allowed by regulators to begin the process of progressive reduction in reliance on ineffective animal models and to encourage the use of models based on human biology.

This reform would allow use of nonclinical test methods based on human biology. It will ultimately streamline drug development, spur innovation, and move drug development forward, benefiting both patients and industry.