It's was never approved because of one person that was continually harrased if it wasn't for her it would have been approved . There were only 11 people responsible to review these new drugs . For crying out loud pcp was approved as an analgesic after using it on a few prisoners . FDA's stringent approval process is required
The downside of that is greatly reduced new drug development due to the expense, much more expensive drugs, and years of delay for the ones that are worked on. If you have a less popular disease, or can't wait years, you're out of luck.
Drug companies can charge whatever they want for less popular diseases. 45% of new approvals last year were for rare diseases. In the industry, rare diseases are sought out as ideal targets because of some regulatory advantages and market power. And there has been an obscene amount of money pouring into biotech and drug development over the past few years - probably one of the most active bull markets the industry has ever seen, with huge numbers of drugs in clinical trials and all sorts of fundamental new technologies under development. Industry's doing fine under the current regulatory regime, with this being one of the best times in history for development of rare disease drugs
