Wednesday, June 22, 2011

Change and the FDA

Finally, we might have some progress on the standoff in the blame game - insurance companies blame hospitals who blame big pharma on the reasons for high medical costs - or is it vice-versa? I have chemo brain I can't remember but you get the point.

Now biotech is trying to work with the FDA to change their mission to help speed up the approval of new drugs. On one hand we have biotech who wants to get things on market faster so they can start making some money - no problem in that. It helps reduce their overhead and makes drugs less expensive to develop. On the other hand, the FDA is cautious about approving drugs too quickly so we don't have more 'Vioxx incidents'.

I can understand both sides and I am glad to see that they are taking the stance of we need to change the overall mission of the FDA. Patients need safety. There is a huge overall burden of cost resulting from years of drug development, testing and trials to meet FDA requirements. However if there is a way to alter this that doesn't cause harm to patients or increase costs in the long run, I am all for it.

I am glad to see that this is recognized as a fundamental change needed. Government agencies, and other large organizations, can get buried in red tape and if every so often they take a step back and say 'let's simplify life for everyone', change can happen and reduce the red tape at the same time.

Next on the list is insurance companies. Hmmm..... finger tapping, tap, tap, tap.... what can we change about them? Profits? Denied coverage? Control over allowable procedures that are medically necessary? Don't get me started. Its too early in the day. But they are next.

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