The FDA now has the option to approve drugs that are tested in only non-animal studies

Simone Smith

simone@carib101.com

TC REPORTER

The U.S. Food and Drug Administration (FDA) no longer requires new drugs to be tested in animals before being approved. This is thanks to a law passed in December 2022. FDA Modernization Act 2.0 authorizes the use of certain alternatives to animal testing, including cell-based assays and computer models, to obtain an exemption from the Food and Drug Administration to investigate the safety and effectiveness of a drug.

The bill also removes a requirement to use animal studies as part of the process to obtain a license for a biological product that is biosimilar or interchangeable with another biological product.

The agency now has the option to approve drugs that are tested in only nonanimal studies, including those that use labgrown tissues or computer models, before being tested in clinical trials with humans.

The question is: is this safe, and will it happen any time soon?

Previously, the FDA typically required drugs be tested in one rodent and one nonrodent species, before they were moved into human trials These animal tests help to reveal how drugs break down in the body, whether they reach the tissues they’re intended to target and whether they exert the intended effects on those tissues, all without having harmful side effects. Unfortunately, these tests are not perfect: more than 90% of drugs that pass initial animal tests end up being unsafe or ineffective in humans, according to a 2019 review in the journal Translational Medicine Communications.

Jim Newman, Communications Director at Americans for Medical Progress shared his thoughts in a press release.

“The entire research community is fully and enthusiastically supportive of adopting non-animal alternatives that can reduce or replace animal research. We would all like to lessen the need for animal studies.

Just like most other Americans, the research community - which is made up of scientists, veterinarians and other dedicated animal care employees - loves and appreciates animals. However, it’s also vitally important for the public to understand that computer models, organs-on-a-chip and organoids are not able to replace animal studies in most cases because these technologies are still in their infancy. As a result, they only provide a limited amount of information required in the drug safety testing process and also in other health research areas.

The study of living systems (aka animal models) is crucial as it allows us to observe and monitor this process closely and learn what happens in a living, breathing body.

Finally, alternative models (such as computer models) can only mimic what we already understand about the human body. As a result, there are many areas where we have a tremendous amount to learn.”

There have been other promising alternatives to animal testing: organoids, or 3D clusters of lab-grown cells mimic key biological features of full-size organs. These organized clumps, often derived from stem cells, are especially useful for observing celland tissue-level drug responses, as well as assessing how well drugs latch onto their molecular targets There are also spheroids (simpler 3D clusters of cells) that are often used to model cancerous tumors spheroids grown from primary cell lines.

The challenge will be convincing drug developers to adopt new, non-animal testing methods. There will need to be evidence that the models show equivalent or superior performance to animal testing, and reassurance that the FDA views the tests as robust before they heavily invest in new technology. Once they do, that will provide the FDA with more evidence that these tests can replace animal testing.

At the end of the day, there has to be valid, scientifically proven methods for ensuring that the medications that pharmaceutical companies continue to push are safe and effective (sigh). While the scientific community is excited about the development of non-animal alternatives, the adoption of these technologies will take significant time.

BMHC aims to address the disparities in mental health care faced by Black individuals and communities and promote culturally responsive mental health services.

It was truly an empowering and enriching day when it was announced on Friday, February 24th, 2023, in a press release that Black Mental Health Inc. will be receiving close to $1.5 million to support the mental health of Black individuals and Black communities.

Black Mental Health Canada (BMHC) advocates for culturally safe, accessible and affordable Mental Health Care for the diverse Black communities in Canada. The mission of BMHC is to improve the mental health and well-being of Black individuals and communities in Canada by advocating for culturally competent mental health services and promoting community education and empowerment. Furthermore,

In order to accomplish this mission, BMHC is driven by the vision to create a society where Black individuals and communities have equitable access to culturally responsive and effective mental health services, and where mental wellness is valued and prioritized within Black communities. One of the core values that undergirds this vision is the belief that mental health is a fundamental aspect of overall health and well-being, and that all individuals, regardless of race or cultural background, deserve access to high-quality mental health care.

BMHC promotes its vision by:

• Advocating for change

• Raising awareness about the unique mental health needs of Black communities in Canada

BMHC will be receiving $400,000 for its project that will develop Black-centric, traumaresponsive community support services in

Toronto’s Regent Park community. Nazario Ahmed, Executive Director and Co-Founder of Wanasah states, “With a Black Centric and Cultural trauma program in Regent Park and neighbouring communities, we can help build trust, restore dignity, and promote a sense of purpose and belonging. This is not just about addressing past trauma, but also about building a better future for generations to come.”

Honourable Marci Ien, Minister for Women and Gender Equality and Youth states, “The road to recovery is complex for those who have experienced mental health challenges and trauma-especially for people who face social exclusion, marginalization, and stigma. This is why our government is proud to support organizations like Black Mental Health Canada and Wanasah to build Black-centric and trauma-response services to better serve the mental health needs of these communities.”

The Honourable Carolyn Bennett, Minister of Mental Health and Addictions and Associate Minister of Health states, “Black communities in Canada continue to face many systemic challenges and barriers to mental health care, and our govern - ment is committed to addressing them. The projects announced today will create environments for improved mental health outcomes and will ensure that Black individuals and communities across Canada experiencing mental health challenges have access to the most appropriate, culturally relevant supports and services they need by the most appropriate provider.”

Alice Wiafe, President of BMHC notes, “We are honoured and excited to receive funding from the Public Health Agency of Canada to further our mission of promoting mental health and wellness in Black communities. With this funding, we can expand our programs and services to better support the mental health needs of Black Canadians, who have historically faced systemic barriers to accessing appropriate care. Our team at Black Mental Health Canada is committed to working tirelessly to ensure that our communities receive the support they need to thrive, and we thank the Public Health Agency of Canada for their investment in our work.”

Anyone interested in learning about Black Mental Health Canada, can check: blackmentalhealth.ca