Friday, 13 January 2023 15:35

Success: US amendment allows drug approval without animal testing Featured

At the end of December 2022, U.S. President Joe Biden signed the "FDA Modernization Act 2.0." Under this law, it is no longer necessary to test the safety of drugs on animals in order to obtain approval from the U.S. Food and Drug Administration (FDA), the government agency that oversees food, drugs, and medical devices. This could initiate a significant reduction in animal testing after more than 80 years of safety testing of drugs on animals.

The signing of the law is a consequence of events that have already been going on in the background in the United States for some time. For example, work has already been underway for several years as part of the CiPA initiative to recognize animal-free methods in cardiac toxicity testing in terms of a testing strategy.1 Countless validation studies in recent years between developers of animal-free methods and the drug industry have already proven their effectiveness and better suitability than animal testing. For example, as early as April 2022, the FDA had shown itself open to such an approach: The results of an efficacy study with an in vitro disease model to treat a rare autoimmune disease were accepted by the government agency in April last year when applying for a clinical trial.2

In an open letter, a group of international companies developing human-on-a-chip technologies addressed key members of the U.S. Congress in early September last year urging them to support the so-called FDA Modernization Act as part of a legislative package.3 They pointed out the unreliability of animal test results, which has led to the death of patients despite harmless animal test results, and to the withdrawal of numerous drugs. Serious toxic effects of 43 drugs were found after regulatory approval, of which only 19% showed a direct relationship of toxicity in animal studies. The authors recommended instead the use of microphysiological systems, organ chips, spheroids, and organoids, which are known for their accuracy and better prediction of toxicity in humans.

Then, as early as September 29, 2022, the U.S. Senate passed the FDA Modernization Act 2.0 without a dissenting vote4, which eventually resulted in the signing of the law by the U.S. President.5 This is also a logical step after U.S. Food and Drug Administration (FDA) officials earmarked a portion of their requested 2023 budget to develop a "comprehensive strategy" for alternative methods of testing (NAMs).6

The signing of the bill is a recognition, but also an appreciation, of years of hard work in developing meaningful animal-free methods. But: it should not be overstated, as animal testing is still possible. In fact, the amendment, which in one section replaces the term "animals" with "non-clinical tests," says that work can be done with cell-based assays, organ chips and microphysiological systems, computer modeling, other non-human or human biology-based testing methods, such as bioprinting, but also with animal testing.

Is Europe switching to the wind?

While some progress has been made in Europe on the decision to move toward animal-free chemical testing and the announcement by the European Partnership for Alternatives to Animal Testing that it will develop a roadmap to phase out animal testing in this area, it is not yet as far along in the area of pharmaceuticals: the European Medicines Agency has indicated in an accountability report for 2022-24 that due to a lack of financial and human capacity, new animal-free methods are not currently a priority.7

An EMA 3r working group addressing the non-clinical area of drug development intends to follow up on the actions taken in response to the European Parliament resolution of September 16, 2021 (2021/2784(RSP)).8 The Commission's response to the Parliament resolution on phasing out animal testing stated that the pharmaceutical strategy for Europe recognizes the need to promote the ethical use of animals in drug testing - this means continuing to follow the 3Rs principle.9

The aim must therefore be to convince the regulatory authorities to optimize any methods that may have been developed and to develop methods that may still be lacking. As far as methods have then proven to be comparably good or even better, animal testing should no longer be allowed.


Further information:
5 Meredith Wadman (2023). FDA no longer needs to require animal tests before human drug trials New law welcomed by animal welfare groups, but others say change won't happen fast. Science Jan. 10, 2023,
7 European Medicines Agency, EMA/32271/2022, Final programming Document 2022-2024.
8 European Medicines Agency, Consolidated 3-year non-clinical work plan, EMA/CHMP/633829/2022.
9 European Commission SP(2021)787-0. Follow-up to the European Parliament non-legislative resolution on plans and actions to accelerate a transition to innovation without the use of animals in research, regulatory testing and education.