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.

ISO 13485/9000 is the baseline

This medical device company I know has finally wrapped up their ISO 13485 certification and they are pretty jazzed about it, even though doing so is probably going to end up delaying their project by several months due to pulling people off project work and putting them on paperwork. However, my thinking now is that certification is unimpressive and if you're making a big deal out of this, you might have bigger problems down the road. Ten years ago, maybe this was cause for celebration, but as it stands now, ISO 13485 and 9000 are pretty much the baseline and while you will undoubtedly run into some quirks (obviously more depending on the size of your company), it shouldn't be a major effort to get certification and if it is, then maybe you should think about adding, changing, or training personnel. There are something like 400,000 companies ISO 9000 certified now, I'm just saying, if you have a hard time joining that elite group perhaps some changes are needed.

UPDATE: Tom in the comments makes a similar point: "The big deal with 13485 is that it has to be done day by day as a normal part of medical device product development. If one has to stop and "catch up" with paperwork, not only are you doing it wrong, but missing a lot of the benefits that a great quality system can give you." If you don't have the resources to keep up ISO 13485 as Tom notes, then a rethinking is in order.