It’s no secret that scientific and technological innovation has been accelerating 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 being monitored, regulated, and vetted for safety and effectiveness?
Traditionally, federal agencies such as the FDA, CMS, and the Federal Trade Commission have played a pivotal role in evaluating pharmaceuticals and medical technologies. By means of assessing analytical validity, clinical validity, and clinical utility, the number of new entries into the marketplace has been limited and the quality of new products has been ensured.
The rapidly evolving nature of today’s biomedical technologies, coupled with the sheer volume of new products, has led to some serious gaps in regulatory oversight.
The burgeoning field of genetic testing is a classic example. Once confined to scientific laboratories and academia, genetic tests are now being developed commercially and sold to the public for a broad array of purposes – clinical diagnostics, law enforcement, and immigration to name a few. Most of these genetic tests are not regulated, and there is growing concern around their marketing without any independent analysis to verify the claims of the sellers.
Current trends in biomedical device manufacturing and marketing raise concerns as well. Consider that laypersons are now building biomedical technology devices and selling them directly to consumers for a variety of applications. For instance, there are transcranial nerve stimulators (FDA-cleared devices designed to influence brain activity using a magnetic field) being manufactured and sold online in assemble-it-yourself kit form!
A recent article by Mathews and colleagues describes how and why we’ve arrived at this juncture and, importantly, presents a thoughtful approach to re-framing biomedical technology governance in a way that takes the changing technological landscape into account.
The authors home in on two key underlying problems:
Existing governance structures were designed for research and development with a laser focus on safety. Development and use of emerging biomedical technologies raises fundamental moral and ethical questions (eg, intervening in the human brain or modifying the genome) as well as “concerns related to dignity, civic responsibility, beneficence, 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 an individual regulatory agency’s purview. We now recognize that the complexity of current biomedical technology development and diffusion precludes governance by a single entity.
Clearly, the speed of technological evolution demands a more comprehensive approach to governance – one that spans multiple sectors, applications, and stakeholders. Trends in governance are beginning to shift towards coordinated approaches in which diverse experts from a range of 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 permits assessment along a range of axes (eg, affordability, access, and distribution of benefits and harms) at a particular point in time and over time as the 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 perspectives on various aspects of emerging technology. Committee members drawn from various academic disciplines, professional backgrounds, and sectors are developing a comprehensive framework to help reshape the governance ecosystem. Lessons learned over the past 2 years will be useful in developing a cross-sectional governance framework that addresses existing inequities and facilitates rapid translation of health and medical innovation principles into meaningful policy choices.
Why the urgency for a regulatory policy reboot? To paraphrase the authors’ iteration of a methodological premise known as the “Collingridge dilemma,” policymaking is impeded early in the development of new technology because of uncertainty and a lack of sufficient evidence about its impact. Once the technology is “highly diffused” and its harmful effects have become evident, it is far more difficult – and, in some cases, too late – to take action.
My sense is that, even though we’re slow at the starting gate, it’s not yet too late.