Hastening FDA Approvals …

I am currently reading a book by Tom Friedman about the pace of change in our world today. I will soon be putting out a post on the book but the point for mentioning it here is that it has gotten me to think differently about many of our current regulatory process and how they need to be speeded up. One of those areas is the FDA approval of new drugs.  There are many in my generation who are very risk averse, they will do almost anything to reduce risk to as near zero as possible.  Unfortunately that concept is proving to be more  harmful than helpful in our fast moving world of today and especially tomorrow.

I can remember in my corporate worklife how the stodgy corporation I worked for when they told me “We encourage you to take risks, just never fail”. In other words don’t take risks. If we are to survive the coming years we need to shed that mentality.

If Tom Friedman is correct, and I think he is, medical technology will be speeding up more and more in the coming years. Now that  the gnome has been mapped we are starting to learn at a much more rapid pace than ever in the past. As is the case in the technology field what is invented today will be obsolete in three to five years to be replaced by the next generation of advances.  We are now advancing in these fields more in 5 years than in the previous one hundred and that pace will only become faster and faster in the coming years.

To me it goes something like this.  Yes, we can spend 6 years testing a drug to make sure that that one person in 10,000 is not harmed but by doing that we are denying the other 9,999 the benefits of its use.  We simply can’t go at a snails pace when the rest of the world will be running like jackrabbits. Even now the U.S. is falling behind in the drug race. Part of it is due to the extreme testing process and another by the exorbitant profits demand by U.S. drug manufactures. Too many regulations in one area and not enough in the other…

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