FDA Modernization Act of 2021

The federal government drug development model is broken. Relying solely on animal tests to determine the safety and efficacy of new drugs hasn’t brought the desired results. The reality is, 95 percent of drugs fail in human clinical trials after animal tests purportedly show safety and efficacy.

The FDA Modernization Act is an answer to these problems.  It seeks to amend the Federal Food, Drug and Cosmetics Act to eliminate the 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).

Human-relevant cell-based assays, organs-on-a-chip, human-on-a-chip (microphysiological systems), and sophisticated computer modeling have been developed to more accurately predict human response to new drugs, yet the Federal Food Drug & Cosmetics Act (FFDCA) does not officially acknowledge these superior test methods.  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.

Fortunately, instead of turning to decades-old technology that has shown limited value, the pandemic has forced people to think differently and use modern, human-relevant technology which has greatly contributed to the search for vaccines and treatments. The global organs-on-chips market is expected to grow from $20.53 million in 2020 to $84.09 million in 2025.

Recently, Israeli scientists at Hebrew University created a cancer drug using a “human simulator chip”, completely circumventing animal tests. This demonstrates that the use of modern, human-relevant technology can lead to faster, safer and more effective drug development. Getting a drug to the point of clinical trials normally takes at least four to six years, thousands of animals and costs millions of dollars.

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.

The bipartisan FDA Modernization Act of 2021, S. 2952, was introduced by Senators Rand Paul, R-KY, Cory Booker, D-NJ, Mike Braun, R-IN, Ben Ray Lujan, D-NM, and John Kennedy, R-LA, will allow use of nonclinical test methods based on human biology, instead of only animal tests.  This bill is a companion to H.R. 2565, a bipartisan bill introduced earlier this year by Representatives Vern Buchanan, R-Fla., Elaine Luria, D-Virg., Brendan Boyle, D-PA, and Mikie Sherrill, D-NJ, to lift requirements for only animal testing for new drug development and enables FDA to accept the most effective testing methods, regardless of whether animals are used.

With a bi-partisan vote of 392 to 28, the House passed the FDA Modernization Act as a rider to a larger package of FDA-related reforms, strengthening the chance of enactment this summer for a measure that would eliminate a statutory animal testing mandate for new drug development. The Senate Health, Education, Labor and Pensions Committee will soon hold a “markup” hearing on parallel legislation, which also includes the FDA Modernization Act as a rider.

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.