Why We Need an FDA 2.0

Michael Mandel, from the Progressive Policy Institute, just released a great short paper, “How the FDA Impedes Innovation: A Case Study in Overregulation.”

He discusses the FDA’s decision to deny approval for a new diagnostic device called MelaFind, which is designed to help physicians identify cancerous lesions while they’re still small enough to be treated successfully. Melanoma is a type of cancer that can be treated very cheaply and successfully if its caught early, and is often rapidly fatal if it’s not. There aren’t many good treatments available for metastatic melanoma, although new treatments are coming online.

MelaFind is designed to help dermatologists or other physicians home in on suspicious lesions for followup — a kind of quick digital second opinion. The technology isn’t perfect yet, but then again, neither is dermatology. Identifying suspicious lesions is at least part art, and inexperienced dermatologists can easily misdiagnose potential melanomas (or biopsy ugly lesions that are harmless). 

Still, the FDA’s concern about the technology, Mandel writes, appears to be that MelaFind doesn’t work as well as experienced, board-certified dermatologists. Mandel writes,

This is a standard that no first-generation device can ever reach.  If the FDA fails to approve MelaFind, it would be the equivalent of rejecting the first cell phone on the grounds that callers might mishear important messages. 

This is a great metaphor. Let’s press it a little further. 

First-generation cell phones were horribly clunky, finicky devices. They were the size of bricks and weighed nearly as much. They cost thousands of dollars. They bear almost no resemblance to the sleek computer/encyclopedia/camera/camcorder/GPS/music library that you carry in your pocket today. Arguably, the least interesting thing you can do on your iPhone is make phone calls. 

Back to MelaFind. What would happen if the FDA approved MelaFind?

Some insurers would cover it. Some wouldn’t. Some doctors would use it, and complain to the company when it didn’t work as advertised. They’d improve it. Some competitors would develop a better algorithm for detecting melanoma, or a super-fast biopsy probe you could carry in your pocket, or a 99 cent app on the iTunes store that worked nearly as well. And maybe some daring charity would distribute MelaFind to dozens of tiny villages in rural countries where there are no dermatologists.  And so on.

Or maybe insurers and doctors would decide it didn’t work at all, and throw it on the dust heap of mediocre ideas. 

No government agency mandated any of the astonishing innovation surrounding cell phones — as Mandel points out — and if you had to wait for the iPhone before any cell phones could be sold, there wouldn’t be an iPhone today. Or we’d have to wait a few more decades for it.

We’re not talking about a chemotherapy drug. Or an invasive surgery. We’re talking about a platform for ideas. For innovation and competition.  

The FDA needs to recognize this and find a way to fast-track devices like MelaFind with the recognition that they are works in progress. Right now, the agency is saying, “Don’t bother us until you’re perfect.”

Innovative companies and their investors developing novel tech will just hear “don’t bother.”