Aug 25, 2008

FDA Drug Approval Rate Down

From FP:

...the number of new drug approvals has fallen dramatically. The FDA approved just 16 new drugs last year, and is on pace to approve only 18 this year. That's down from a high of 53 in 1996 and 39 in 1997.

I think FP nails it when they say: The US Food and Drug Administration (FDA) and similar agencies in other industrialized countries get politically punished more for approving drugs that turn out to have unexpected side effects. At the same time they few rewards for taking risks to approve drugs that might turn out to deliver large benefits.

It is unlikely that the FDA will change despite all of our wishing. It is much easier for medical devices than drugs to get approval, but the regulations are tightening, particularly in regards to software and devices which communicate with other devices, these are facing more scrutiny (still you know, now may be a good time to invest in medical device companies instead of drug companies- although I always think this). This scrutiny would be fine and good if it was deserved, but the EU has allowed these and other devices with less oversight and while the FDA has a few feathers in its cap about doing the right thing while the EU took excessive risks, I'm not sure it is warranted in most cases. On the bright side, things could be worse, it could be Japan.


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