An FDA inspector can cause millions of dollars of losses by shutting down operations or triggering recalls if he feels that any of these regulations are not being followed strictly, which by FDA definition compromises safety. He requires no actual evidence of product quality problems to do so, and there is significant precedence of recalls for quality system regulation violations with no demonstration of actual product quality problems.

Generally, the FDA regulations are reasonable design and development practices for high reliability, safety critical products. However, because the FDA requires proof in their terms for following them, this imposes a large cost overhead. This cost overhead serves as an impediment for new small companies to compete with inefficient, existing larger manufacturers. For this reason, medical device design and development cycles are generally slower and device evolution takes years longer than other comparable unregulated high-reliability industries. For evidence, compare the technology age of the CPU in an average medical device and compare it to the age of the CPU in any unregulated high reliability, hi-tech product (e.g. disk drive storage). The unregulated product product will generally be designed with newer, cheaper, more state-of-the-art options because their design and development cycles are far shorter. Yet, I have seen no evidence that regulated products have higher quality and reliability. This regulatory burden is also a significant contributor to the overall cost of health care.

Of course, as soon as I read the paragraph I connected it to health care. It’s not going to be instant obviously, but we will get to a point where we no longer develop new treatments or drugs simply because insurance companies won’t want to pay for them, whether due to lack of funds from providing mandatory coverage or from medical providers seeing no purpose in providing a service/product cheaper when the government is footing the bill.

In short, the free market is the only thing that could possibly save our form of the health industry. The GOP’s bill introduced a few days before the Democrat’s plan was a far better step towards a solution, but still not right. The barrier to entry into any medical business is too high; you have to get federal licenses, state licenses, and FDA approvals. If you really want to bring costs down, quit strangling the market with the vine of regulations.