Glee, Christmas Miracles, and the FDA

Let's talk Glee. There are a number of things that are realistic on that show. People can sing. People can dance. BUT people cannot find Rewalks under their Christmas trees in the United States of America.

Sorry, Artie. Source*

Why? The easy answer is that the FDA hasn't approved it yet. That could be because of concerns that the V.A., Medicaid, and other payers may not be able to fund an expensive device like the Rewalk Personal. But the FDA's refusal to approve it clearly flies in the face of its mission statement to "protect and advance" public health. While the FDA has approved Rewalk Rehabilitation, a model only used in medical facilities, it has remained quiet about its plans regarding the Rewalk Personal, which individuals can take home to use where and when they please. 

The issue came up recently during President Obama's visit to Israel. As the President viewed a demonstration of the Rewalk by two disabled veterans (U.S. Sgt. Theresa Hannigan and Israeli soldier Radi Kaiuf), Rewalk's creator, quadriplegic Dr. Amit Goffer, had this to say:

“This device is already improving the quality of life for many people and we look forward to seeing its continued expansion around the world including in the US where we are awaiting FDA clearance for daily personal use.”

In other words, it is a shame that Americans who are disabled cannot join the over 100 individuals in Europe and Israel who are currently benefiting from the device. 

In my first post, I asked what the price of FDA interference and so-called protection is in terms of time, efficiency, and money. Here, it is clear that the effects of FDA inaction go beyond that. There are people sitting at home right now who could be walking, or at least raising money to be able to walk, as this man is trying to do in Leicestershire, England, or as Claire Lomas, a British athlete, succeeded in doing. Dr. Goffer, who was inspired to create Rewalk because of his own struggle with paralysis, said he hopes costs will go down soon as the company shifts to mass production. He also stated that Rewalk does much more than merely improve people's fitness. As one woman stated, the best part is being able to speak to other adults at eye level. Why is the FDA holding people back from improving their health and emotional well-being? 

Claire Lomas breaking old boundaries at the London Marathon thanks to Rewalk. Source*

I can think of only two possibilities. Either Rewalk Personal is sitting on a desk somewhere and FDA employees are too busy measuring caffeine in syrup to bother with it, or they are waiting for the device to gain enough traction and popularity in Israel and Europe to enable the company to shift to mass production so that the costs will be lower by the time it hits the American market. In the meantime, it is one less thing to worry about fitting into Obamacare.