This, from this morning’s Wall Street Journal:
The Food and Drug Administration proposed shoring up medical-device approval rules that have been criticized as lax and inconsistent by consumer advocates and the agency itself.
The FDA aims to better define what devices can use an approval pathway known as 510(k), under which companies can get an accelerated decision on whether they can market a new product if they can show it is similar to an already approved device. The proposals, which will be open for public comment, will be closely watched by the device industry because more-stringent rules would raise development costs.
Since in politics, anything you say can and will be used against you, let’s start by saying that medical devices that are supposed to help us shouldn’t kill us, and the FDA plays a useful – although an exclusive – role in making sure that doesn’t happen.
That said, this is bad news for health care and bad news for Colorado. Medical innovation is the single, surest way of bringing down costs. New technologies cost more, sure, but they bring down the relative desireability, and thus the relative price, of existing technologies.
Think about your cell phone. Everything about it, from the signal to the network to the phone itself, is in a relentless drive towards being commoditized. Which means that you can get an iPhone for about 1/2 the real cost of a cell phone ten years ago, and pay only slightly more for the network access. The same factors are at work in every market.
And bad news for Colorado? Well, we’re home to some of the best, most innovative biotech companies around, which up until last year, attracted a lot of venture capital money.
Let’s hope the FDA doesn’t make things worse, and that if they do, that our Congressional delegation has the sense to stand up for innovation, rather than demagogue about “rich” “companies” “profiting” “at our expense.”