The impact of the FDA Modernization Act 2.0 on Biomaterials and Medical Devices
Nearly a year has passed since the enactment of the FDA Modernization Act 2.0. This is the legislation that revised and modernised existing regulations that oversee the approval and utilisation of medical products in the United States. The FDA Modernization Act 2.0 is the act that came to address the need for alternatives to animal testing for purposes of drug and biological product applications.
The FDA Modernization Act 2.0. indicates the need for a substantial shift away from mandatory animal testing for investigational drugs. While not outright banning animal research, the law acknowledges its limitations and empowers researchers to embrace innovative non-animal methods. This shift recognizes the potential of advanced techniques to accurately model human physiology, potentially revolutionizing the speed and success of drug discovery.
Historically, the absence of toxicity testing mandates led to a tragic incident in 1937, causing numerous deaths. Consequently, the Federal Food, Drug, and Cosmetic Act of 1938 mandated animal testing for new drugs. However, ongoing concerns about the efficacy of animal testing led to the establishment of the “Three Rs” principle in 1959, emphasizing Replacement, Reduction, and Refinement in animal use.
The FDA Modernization Act 2.0 encourages researchers to explore alternatives to animal testing. A major aspect of the act encourages the adoption of advanced cell culture systems, particularly microphysiological systems (MPS), for testing and developing new medical products. MPS, which replicate human tissue and organ structure and function, are gaining popularity in the pharmaceutical and cosmetic sectors. Their capacity to offer more precise and reliable insights into the safety and efficacy of new products has led to increased utilisation. Moreover, the ability to mimic or recapitulate the in vivo conditions in cost-effective in vitro models results in faster development and reduced costs for new products. This ultimately leads to better patient care and quality of life, and has profound impact on policy making and global healthcare economics.
Several approaches are thus emerging form the new act, such as the use of:
· Organoids: Cultures of stem cells that self-organise into 3D structures resembling organs, offering insights and drug screening platforms.
· Organ-on-a-chip: Microfluidic devices mimicking organ architecture and physiology, enabling multi-organ systems without preclinical animal data.
· Human tissue studies: Evaluating therapeutic interventions on disease-specific tissue derived from volunteers or surgical procedures.
· Phase 0 clinical trials: Administering sub-therapeutic levels of a drug to study participants to identify changes in physiology and assess potential toxicity.
· Digital twins: Predictive models generated through machine learning from patient data, minimising the need for animal testing.
The FDA Modernization Act 2.0 emphasizes the use of the most rigorous scientific methods available, leaving the choice to researchers to adopt the approach with the greatest potential for bringing safe and effective treatments to market. Additionally, it has implications for biomaterials and medical devices, particularly in the context of regulatory approval and testing methods. The Act promotes advanced testing methods, including non-animal alternatives, thus it encourages the use of advanced and rigorous scientific methods for testing and it signals:
· Reduced Reliance on Animal Testing and emphasis on In Vitro Models. Organoids and organ-on-a-chip systems gain prominence for testing biomaterials and medical devices.
· Accelerated Development: In vitro models mimic in vivo environment, potentially leading to quicker development times of therapeutics and diagnostics.
This Act, thus, could have enormous impact on Clinical Trials, as it may influence their design and execution, supporting funding for digital twins and Phase 0 trials, and alternatives to animal testing for medical device development.
This Modernization Act should further extend, and its impact should be translated onto research funding. In the context of biomaterials, it should also encompass the use of medical devices by encouraging initiatives that prioritise the development and integration of advanced testing methodologies. Funding for traditional animal testing with innovative in vitro models that closely mimic human physiology should support projects aiming to utilize medical device research in technologies like organ-on-a-chip systems and advanced cell culture techniques.
Emphasis should be placed on projects that align with the Act’s commitment to rigorous scientific methods, ensuring that novel testing approaches for medical devices are both accurate and reliable. This comprehensive funding strategy would drive advancements in both drug development and medical device testing, furthering a shift toward more ethical, efficient, and scientifically robust practices. That would ultimately lead to profound impact on policy making and global healthcare economics but even more importantly to better patient care and quality of life.
Author: Athina Samara, Department of Biomaterials, FUTURE, Centre for Functional Tissue Reconstruction, University of Oslo
Links
[1] US Food and Drug Administration. Modernization in Action 2022. 03/30/2022. https://www.fda.gov/about-fda/reports/modernization-action-2022
[2] “A new path to new drugs: Finding alternatives to animal testing”. Michelson Philanthropies. 1 Sep 2023. Science.org. https://www.science.org/content/resource/new-path-new-drugs-finding-alternatives-to-animal-testing#:~:text=In%20December%202022%2C%20passage%20of,employ%20innovative%20non%2Danimal%20methods
Keywords
FDA, Modernization Act, medical devices, animal testing, biomaterials, microphysiological systems