Can the FDA Keep Up with Healthcare’s Rapid Innovation?

A new paper from the Mercatus Center at George Mason University examines coming advances in medical technology and how they will likely disrupt the current regulatory structure of the Food and Drug Administration.

According to Adam Thierer, senior research fellow with the Technology Policy Program at the Mercatus Center and author of the paper, the practicality of the FDA’s “command and control” approach to approving new drugs and medical devices will increasingly decline as innovations such as personalized medicine and 3-D printing become more prevalent.

Furthermore, Thierer argues that for these innovations to come to fruition in a timely manner, the FDA should embrace the concept of permissionless innovation and shift into a role of “risk educator” rather than a risk regulator.

Thierer is not the only one to question the FDA’s command and control approach as technological disruptions become more frequent in healthcare. In The Wall Street Journal, Charles Koch recently wrote about how the FDA could inhibit well-being:

The state often claims to keep its citizens safe, when it is actually inhibiting increased individual well-being. See, for example, the FDA’s astronomically expensive and time-consuming drug-approval process, which University of Chicago professor Sam Peltzman argues has caused “more sickness and death than it prevented.” These kinds of harmful barriers to life-enhancing advances exist at every level of government.

Allowing patients the right to try new medicines, products, and treatments while educating them on the potential risks could usher in a new wave of life-saving innovations as entrepreneurs are freed from the overbearing regulations that currently discourage rapid advancements in medical technology.

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