FDA's Pharma-First Focus Driving Medical Device Tech Away From The US
from the total-failure dept
Reason has an article about how the FDA is driving medical device innovation to Europe and elsewhere because it's still not set up to even think about medical devices. The article focuses on the new X-Prize attempt to create a "tricorder." It's a great contest, but then the article points to the news that the FDA won't certify such things:
The regulatory environment could present problems for any such device. "The Food and Drug Administration has stated that it will not certify tech that makes a diagnosis directly," said Ross Mitchell, the author of a study published last week that shows that strokes can be diagnosed with the aid of a smart-phone application with the same degree of accuracy as with a hospital computer.Indeed, the report points to many other examples of useful new technologies showing up elsewhere, but not in the US due to the FDA. So why is the FDA so bad at actually helping people get healthy? Take a guess. It seems like regulatory capture has taken hold of the FDA in a big bad way. Just recently, we discussed how the FDA has set up a system to limit competition in the medical field to just a few giant pharma companies, and has been actively banning cheaper drug competitors, in order to help big pharma companies jack up the prices on old medicines.
Bartholomew says that because of FDA restrictions, the contest could lead to innovations that might only be used outside the United States.
While the FDA is supposed to be keeping us healthy, it looks like its general focus is on keeping the profits of a few pharma firms healthy instead.