Regulatory policy

Regulatory policy for biomedical technologies: it’s time to restart!

It’s no secret that scientific and technological innovation has accelerated at breakneck speed, and nowhere is the evidence more pronounced than in the biomedical technology sector. How, when and by whom are these innovations and their offspring monitored, regulated and controlled for their safety and effectiveness?

Traditionally, federal agencies such as the FDA, CMS, and Federal Trade Commission have played central roles in the evaluation of pharmaceuticals and medical technologies. Through the assessment of analytical validity, clinical validity and clinical utility, the number of new market entries has been limited and the quality of new products has been assured.

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

The burgeoning field of genetic testing is a classic example. Once confined to science labs and universities, genetic testing is now being developed commercially and sold to the public for a wide variety of purposes – clinical diagnostics, law enforcement and immigration, to name a few. Most of these genetic tests are unregulated and there are growing concerns that they are being marketed without any independent analysis to verify the vendors’ claims.

Current trends in the manufacture and marketing of biomedical devices also raise concerns. Consider that laypeople 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 influence brain activity using a magnetic field) manufactured and sold online as a DIY kit!

A recent paper by Mathews and colleagues describes how and why we got to this point and, importantly, presents a thoughtful approach to reframing the governance of biomedical technologies in a way that takes into account the changing technology landscape.

The authors focus on two key underlying issues:

Existing governance structures were designed for research and development with a particular focus on security. The development and use of emerging biomedical technologies raise fundamental moral and ethical questions (for example, intervening in the human brain or modifying the genome) as well as “concerns related to dignity, civic responsibility, beneficence and to other human values”. Many of our current governance mechanisms do not reflect these principles and values.

Current governance models assume that technologies will remain under the purview of an individual regulator. We now recognize that the complexity of developing and disseminating current biomedical technologies precludes single-entity governance.

Clearly, the speed of technological change demands a more holistic approach to governance – one that spans multiple sectors, applications, and stakeholders. Governance trends are beginning to move towards coordinated approaches in which diverse experts from various disciplines and multiple sectors collectively assess emerging medical scientific advances and technologies in the context of their potential implications for society.

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

Why the urgency of restarting regulatory policy? To paraphrase the authors’ iteration of a methodological premise known as “Collingridge’s dilemma”, policy-making is hampered early in the development of new technologies due to uncertainty and lack of sufficient evidence. of its impact. Once the technology is “widespread” and its harmful effects become evident, it is much harder – and, in some cases, too late – to act.

I have the feeling that even if we are slow at the start, it is not yet too late.