Alex Tabarrok, writing at Medical Progress Today
Initially, it was hoped that understanding the genetic code would lead to a slew of blockbusters as we found genes that we could simply switch on or off. Instead of finding master switches, however, genome-wide association studies have tended to find lots of small contributors to disease, with different people having different contributors. As more people are sequenced, it is likely that we will discover even greater heterogeneity of both diseases and persons.
Instead, we must move the FDA away from pre-market gatekeeping and towards post-market surveillance and information provision. By lowering the costs of FDA approval we can increase the profitability of researching and developing drugs for small patient populations. Less pre-market gatekeeping should be combined with universal electronic medical records and extensive post-market surveillance. In an optimal system that trades off risk and benefits, and the better post-market surveillance becomes, the more we should reduce pre-market gatekeeping.
This the type of smart near term based regulatory action I am talking about. We don’t have to be right about the future. Personalized medicine might turn out to be crap in the long run, and indeed I would bet the rejuvenation is going to be a generalized blockbuster treatment that makes most of this stuff unimportant.
Nonetheless, we can see the FDA pinching the market for drugs today. We can see the high costs of R&D today. And, we should do something about it today.