February Popular Science has a round up article on new treatments for various diseases. Two different researchers, on two different projects, are quoted saying they have no plans to commercialize the treatment because getting the treatment thru the FDA approval process is just too expensive.
FDA has been in a CYA mode ever since the thalidomide disaster in the 1960's. They always demand more tests, more clinical trials, more studies, more time, and more money. The small laboratory or independent researcher lacks the money, skill, endurance, and connections to even contemplate entering the obstacle course that is FDA drug approval trials. The classic technique for jacking up prices is to eliminate competitors. FDA is doing that for the pharmaceutical business.
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