4/27/17: Drugs are expensive for one main reason; cost of FDA regulations. New drug submissions require a Phase I to show they are safe. Then a Phase II of 500-1000 cases to show it works. If still positive then a Phase III of 2000 to 10000 cases are required with at least a 2 year follow-up.
Here are the facts. Only 15% of drugs are approved. 85% fail, but unfortunately they fail in Phase III when the millions are spent. So the drug companies must cover the cost of the 85% that fail in the charge for the 15% that pass.
Cases in point: I have a patented means to reduce surgical infections by coating a total joint implant at time of surgery so that any bacteria or biofilm colony would be destroyed upon contact. No total joint company is interested in that the cost of the FDA study would be 50 to 150 million dollars to attempt to gain approval. There would be a humanitarian and societal benefit, but the companies are in business to make money.
It was announced today that back in 2014, Roche spent $725 million upfront on Seragon Pharmaceuticals, but three years down the line, it has now canned work on its leading drug, ARN-810.
