Thank you for the article, Mr. Machan.  I have nearly thirty years experience with the development, manufacture and marketing of medical products. I have witnessed first-hand all of the problems you mention.  I can confirm that, like most government regulation, FDA-promulgated regulations tend to achieve the opposite of their alleged intent.

It is an inescapable fact that for virtually every life-saving drug approved by the FDA, someone died waiting on that approval.  In many cases, thousands of people, who have nothing to lose and everything to gain, would willingly take the drug before final testing and approval.  But in the name of "protecting society", these individuals are denied access to their only hope.

There is also the equally inescapable fact that government regulations concerning product quality tend to become maximums, not minimums. The government mandates a certain quality level, forbids the sale of products of lower quality, and labels all products at or above that threshold as "FDA Approved".  Consumers are thus discouraged from comparing products -- the almighty Federal Government has assured everyone of the safety and efficacy of all medical products.  The absence of comparison shopping reduces the incentive to do any better than the regulations require. Why produce a higher quality product than what the government demands, when consumers are encouraged to view all products equally? So, presto, a government-imposed minimum quality level becomes an industry-wide norm.

Examples of this effect abound, and are not limited to medical products.  How many houses, for instance, are built any better than what is required by the building code?  Contrast this with the ferocious quality-competition within the (relatively) unregulated automobile industry.  The existence of such contrasts certainly calls into question the honesty of the Goozner's of the world.