Legislators: FDA regulatory process outdated, hurts innovation

A few days after initiating new legislation to decrease FDA’s regulatory authority over mobile health, Sens. Deb Fischer (R-Neb.) and Angus King (I-Maine) penned an editorial in USA Today asserting that the agency’s slow regulatory processes hinder innovation.

While the FDA’s work is crucial to patient safety, “its processes are often painstakingly slow and based on outdated assumptions. This halting regulatory pace, along with a lack of bureaucratic incentives to embrace disruptive technological change, has often held back progress,” the legislators wrote.

Given the agency’s practice of sub-regulatory proceedings and selective regulation, some companies remain uncertain as they seek to commercialize new technologies, the senators said.

The current statutory definition of a medical device, which was established more than 40 years ago, gives FDA jurisdiction over nearly "any instrumentality" used in the diagnosis or treatment of a patient. "This overly broad, dated definition is bad news for health innovation... Rather than constraining creativity with obsolete parameters, our laws should reflect our generation," the senators wrote.

Read the entire editorial here.