A company called Cur is developing a promising new pain-relieving product, according to Mashable, Fast Company, and PC World. Problem is, the company is doing it by launching a $50,000 crowdfunding campaign on its own website prior to filing for the necessary FDA clearance. The move could doom the product before it ever hits the market — or it could point to a glaring loophole in FDA regulations. If funding a product in anticipation of receiving said product doesn’t count as a purchase, then the field of medical device regulation is about to get really messy.
“Sounds pretty illegal to me,” says Diana Zuckerman, president of the National Center for Health Research, a nonprofit that analyzes medical treatments in order to see how safe and effective they are. “Even if there is some sort of a loophole for crowdfunding of an advanced purchase of an unapproved product, it certainly sounds like it’s a sale — they’re saying it’s ’50 percent off for 30 days’ — and they can’t sell it if it’s not approved.”
Cur (pronounced “cure”) is a transcutaneous electrical nerve stimulation machine — or a TENS machine — that backers can obtain by funding the campaign to the tune of $149. These medical devices use electrical currents to stimulate nerves and muscles in order to relieve pain. They’re especially popular with physical therapists who use them for pain management, despite the fact that the data on the effectiveness of TENS machines is sorely lacking. (In fact, the American Academy of Neurology gave them a big thumbs down for treating chronic back pain in 2009.) […]
Looking at the Cur website without thinking that the company is selling a product is pretty hard; you can see the words “get Cur now” right at the top. “What I find fascinating is that nothing about this [campaign] says that you’re donating money until you get to this crowdfunding [page],” Zuckerman says. This is the ultimate of ‘don’t forget to read the fine print’ — everything else about this suggests that you’re buying a product.” […]
How the FDA will respond to this campaign is unclear; the agency declined to comment on this story. It’s still possible that a crowdfunding campaign that targets consumers will be interpreted as “investigational use” geared toward a large, and extremely diverse number of “investors.” But scrolling through Cur’s website suggests a far murkier outcome. “It’s a pre-order for something that they may never be able to sell,” Zuckerman says. “And to me, it’s hard to feel confident about the integrity of the product given the lack of integrity of the website. If they have a legitimate product, then the company shouldn’t be selling it this way.”
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