http://content.nejm.org/cgi/content/full/NEJMp1006304?query=OF
The key paragraph is:
"The challenge is to deliver the benefits of this work to patients. As the leaders of the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), we have a shared vision of personalized medicine and the scientific and regulatory structure needed to support its growth. Together, we have been focusing on the best ways to develop new therapies and optimize prescribing by steering patients to the right drug at the right dose at the right time."
Sadly not everyone shares their commitment. There are those in the agencies both of them lead who oppose their vision. I know since I have met and heard them speak. One of them -- from the NIH -- called the ALLHAT study the "gold standard" of evidence-based medicine. Must have received his MD from the Rosa Delauro School of Biomarker Science (Merrill Goozner, Dean of Academic Research).
At the same time, personalized medicine does not automatically translate into faster approvals. It would be easy to chalk this up to agency risk aversion across the board. Rather, I think it is more a matter of over time that the regulatory system has been able to become bloated and expensive because the way health care technologies have been paid for allowed both industry and government to pass the cost of oversight on to consumers, inefficiencies and all. Is the process of developing new medicines risky and expensive? You bet it is. But could it be less so and could industry made or demanded more efficiencies in product cycles and manufacturing? Absolutely. And will more of the fate and future of a produce be determined in the market rather than in the clinical period. That will be true as well. Especially when in comes to finding new uses based on the same pathways in different diseases or disease sites.
So faster approvals will still matter, but faster adoption or approvals for new uses will likely matter more. Which means getting to "no" faster in the early stages of development and finding multiple uses in the real world. And both will depend on personalized medicine as defined by Drs. Hamburg and Collins.
