The molecular economy is coming and today’s regulatory environment isn’t ready for it. First suggested by Christopher Meyer and Stan Davis in their 2003 book “It’s Alive: The Coming Convergence of Information, Biology and Business,” the molecular economy–one based on our ability to see and manipulate matter on a molecular level–will transform manufacturing and commerce. At the heart of the convergence are technologies and techniques such as nanocapsules and genetic algorithms.
The regulatory environment we live with today began around the time penicillin was discovered (see www.laserfocusworld.com/articles/341243). What worked for aspirin and Band-aids won’t work for diagnostic assays and next-generation tissue scaffolds. As David Rejeski, director of the Foresight and Governance Project at the Woodrow Wilson International Center for Scholars notes, the rise of the molecular economy demands a fairly radical change in how we regulate new technologies.
“The easiest way to regulate a future technology is if it acts like something in the past,” he says. That won’t be the case with emerging technologies such as nanotechnologies and synthetic biology products (see bioopticsworld.com/articles/351632). Making a few changes to the current regulatory frameworks may offer a buffer to manufacturers in the short term, but in 10 to 15 years those fixes won’t keep up with the rapid pace of change presented by new technologies.
In the next couple of years Rejeski anticipates few changes in the federal regulatory process for medical devices and drugs, in part because device manufacturers and drug makers tend to interact with the U.S. Food and Drug Administration on a regular basis. “Because they have this type of interaction, FDA can say, ‘We need more data,’” Rejeski says. “When you’re doing work on the frontier, giving FDA a heads-up doesn’t work against you.”
A new regulatory framework that can embrace the speed and complexity of new technologies will rely on public input at all levels. From grad students anonymously notifying a regulatory agency of bad lab practices to consumers relating their experience with a particular drug on a social networking site, the public will be a critical surveillance tool. “There are millions of eyes on the ground and the technology to use them,” says Rejeski. Within the agencies themselves, early warning officers who report directly to regulatory agency head could stay ahead of new developments. These science-rich individuals would look not only at problems with new technologies but also at the opportunities the technologies may offer.
Recently, J. Clarence Davies, a senior advisor to the Project on Emerging Nanotechnologies at the Wilson Center devised a broad-reaching new regulatory agency, which he describes in the Wilson Center report “Oversight of Next-Generation Nanotechnology” (nanotechproject.org/process/assets/files/7316/pen-18.pdf). Davies and Rejeski hope the report sparks debate and begins a discussion about how to transform the current regulatory environment into a nimble, efficient science-driven enterprise. “We need to initiate thinking and dialogue about an oversight system and to do it now because the new technologies and new science are coming faster and faster and some are already here.”
