Those who call for FDA to adopt comparative effectiveness as a regulatory third leg are on a cost effectiveness jihad. And while a little honesty would be appreciated, what's more important is to understand the unintended consequences of such rhetoric on pharmaceutical innovation. So, a brief lesson on the environment in which innovation operates:
Innovation is slow. Unlike on TV, there are few disruptive “Eureka!” moments. Progress comes step-by-step, one incremental innovation at a time.
Innovation is hard. Today it takes about 10,000 new molecules to produce one FDA-approved medicine. And only three out of 10 approved medicines earn back their research and development costs.
Innovation is expensive. The costs to bring a new medicine to market are between $802 million and $1.7 billion. And those costs are rising.
Innovation is under attack. From accusations of the “me-too” variety, to crackpot schemes to replace pharma patents with a “prize” system, life for innovator pharmaceutical companies is rough and tumble.
But innovation is important—and not just for industry profits. From 1970 to1990, increases in life expectancy resulting from better treatment of cardiovascular disease have delivered economic benefits worth more than $500 billion a year. In 1974, cardiovascular disease was the cause of 39% of all deaths. Today it is about 25%. And that's just for the US.
According to Harvard health economist David Cutler: “Virtually every study of medical innovation suggests that changes in the nature of medical care over time are clearly worth the cost.”Peter J. Pitts is partner/director of global health at Porter Novelli and a former FDA associate commissioner