Why You Won’t Be Able to Get the Drug You Need, Part III
This is from a book chapter by Scott Gottlieb on medical innovation. See previous posts here, here and here:
New regulatory requirements are also raising the cost of development, prompting companies to shut down even promising development projects as a way to place resources behind the surest bets. By some measures, the average cost of developing a drug has, over the past twenty years, risen at a rate that is 7.4 percent higher than inflation. The same study found that requirements for larger and longer clinical trials were responsible for most of the increase. Another analysis found that total time from synthesis of a new compound to approval averaged 7.9 years in the 1960s, but rose to 12.8 years by the 1990s. today it is estimated at well over fifteen years.
More depressing news.
The more I learn about the FDA the more apprehensive I become about getting the health care I may need at some point in the future.
The difficulty getting a drug through the approval process causes drug makers to only pursue drugs for the most common chronic conditions. The FDA has made it clear that so-called “Me-Too” drugs will be increasingly difficult to get approved.
Rationing by any other name is still rationing. It is in the government’s economic interest to not let new drugs on the market.