Two prominent federal lawmakers are going public in their fight to keep the FDA from fiddling too much in the mHealth space.
Senators Deb Fischer (R-Neb.) and Angus King (I-Maine) published an unapologetic op-ed in the pages of USA Today this week, urging the creation of a new, less intrusive framework for FDA oversight.
The FDA’s regulatory footprint is growing beyond its statutory shoe size. The overreach comes in various forms, including sub-regulatory proceedings and selective regulation. Companies — including those who have already invested and deployed their technology — are left on uncertain footing given the FDA’s regulatory discretion.
Such heavy-handed moves have caused legitimate concern that the FDA could slow down the development of low-risk health technology, including mobile-wellness applications and electronic health records.
According to the Senators, misguided regulation leads to fewer innovators and frustrated developers who turn away from exploring health technology to other, more hassle-free fields.
“Low-risk health IT deserves a modern regulatory regime — one that promotes innovation, supports jobs growth, and protects patient safety,” they say, adding that “Congress must act and codify the common sense that you can’t regulate new technology with old rules.”
“We’ve offered a bipartisan proposal,” the piece concludes, “that says if people can develop mobile apps to keep neighbors out of the hospital, improve lives, or lower costs, we should get government out of the way and spread the knowledge.”
To read the opinion editorial in full from USA Today, click here.