Skip to main content

News

Trump's Pledge to Slash FDA Regulations Could Put Public at Risk

By smace@healthleadersmedia.com  
   February 14, 2017

An accelerated review process and better tracking could do more to drive medical device and drug breakthroughs than a massive deregulation effort, healthcare leaders say.

This is part of a series covering the Shaping of Healthcare's Future in the Trump era.

A pledge by President Trump to slash regulations at the FDA may run into opposition from health leaders who believe innovation will proceed regardless of the level of FDA regulation, or that too much regulation-cutting could endanger patient safety.

President Trump has promised sweeping rollbacks in regulations across all agencies. But at the Food and Drug Administration, a focus on innovation would be a better way to safeguard patients and get new devices and medicines to market, says Eric Topol, MD.

"There is always a delicate balance between permissiveness and less regulation and oversight, as compared with promoting innovation and getting things out that could help people," he says. Topol is a cardiologist and chief academic officer at Scripps Health in San Diego.

"Setting the tone that we want to see more true innovation accelerated would be a good thing. Often it isn't just the commissioner per se that has the governance" but also those at staff level, he says.


Regulatory Wish List: Which Rules Would Healthcare Leaders Eliminate?


But Topol, author of The Creative Destruction of Medicine, cautions that accelerating innovation carries plenty of pitfalls, as when the FDA last September approved the drug Sarepta for muscular dystrophy.

"They approved the drug with 12 people, 12 kids, and no controls," he says. "This was not an example of acceptable, in my view."

If the Trump Administration opts for wholesale deregulation at the FDA without carefully considering the consequences, the approval process for devices and diagnostics will carry some of the same risks, Topol says.

Pages

Scott Mace is the former senior technology editor for HealthLeaders Media. He is now the senior editor, custom content at H3.Group.


Get the latest on healthcare leadership in your inbox.