Regulatory Policy for Biomedical Technologies: Time to Reboot!

It is no secret that scientific and technological innovation is accelerating by leaps and bounds, and there is no clearer evidence than in the biomedical technology sector. How, when, and by whom do these innovations and their progeny be monitored, organized, and tested for safety and efficacy?

Traditionally, federal agencies such as the Food and Drug Administration, CMS, and the Federal Trade Commission have played a pivotal role in evaluating pharmaceuticals and medical technologies. By evaluating analytical credibility, clinical validity and clinical benefit, the number of new entries in the market was limited and the quality of the new products was assured.

The rapidly evolving nature of today’s biomedical technologies, along with the sheer volume of new products, has resulted in some serious gaps in regulatory oversight.

The burgeoning field of genetic testing is a classic example. Once restricted to scientific laboratories and academia, genetic testing is now being developed commercially and sold to the public for a wide variety of purposes – clinical diagnosis, law enforcement, and immigration to name a few. Most of these genetic tests are unregulated, and there is growing concern about their commercialization Without any independent analysis To verify sellers’ claims.

Current trends in the manufacture and marketing of biomedical devices also raise concerns. Keep in mind that ordinary people are now building biomedical technology devices and selling them directly to consumers for a variety of applications. For example, there are transcranial nerve stimulators (FDA-approved devices designed to affect brain activity using a magnetic field) that are manufactured and sold online in the form of DIY kits!

a last article Written by Matthews and colleagues describes how and why we got to this juncture and, most importantly, offers a thoughtful approach to reshaping biomedical technology governance in a way that takes into account the changing technology landscape.

The authors address two main basic problems:

Existing governance structures for research and development are designed with a laser focus on safety. The development and use of emerging biomedical technologies raise fundamental ethical and ethical questions (eg, human brain intervention or genome modification) as well as “concerns about dignity, civic responsibility, benevolence, and other human values”. Many of our current governance mechanisms fail to take these principles and values ​​into account.

Current governance models assume that technologies will remain within the purview of a single regulatory agency. We now recognize that the complexity of development and deployment of current biomedical technology precludes management by a single entity.

It is clear that the pace of technological development requires a more comprehensive approach to governance – one that includes multiple sectors, applications, and stakeholders. Trends in governance are beginning to shift toward coordinated approaches in which diverse experts from a range of disciplines and multiple sectors collectively assess emerging medical scientific developments and technologies in the context of their potential impacts on society.

The new biomedical technology governance framework described by Mathews and colleagues allows assessment along a range of hubs (eg, affordability, access, and distribution of benefits and harms) at a given point in time and over time as the technology and its uses evolve. The National Academy of Medicine’s Committee on Emerging Sciences, Technology and Innovation (CESTI) in Health and Medicine now provides a platform for diverse stakeholder perspectives on various aspects of emerging technology. Committee members from various academic disciplines, professional backgrounds and sectors are working to develop a comprehensive framework to help reshape the governance ecosystem. Lessons learned over the past two years will be instrumental in developing a cross-sectional governance framework that addresses existing inequalities and facilitates the rapid translation of health and medical innovation principles into meaningful policy choices.

Why the urgent need to restart regulatory policy? To paraphrase the authors’ reiteration of a methodological hypothesis known as “Collingridge’s dilemma“Policy making is hampered early in the development of new technology by uncertainty and a lack of sufficient evidence about its impact. Once a technology becomes ‘too widespread’ and its adverse effects are seen, it becomes more difficult – and in some cases, too late – to take Procedures.

My sense is that even though we slowed down at the starting gate, it wasn’t too late.

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