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A proposal | 134 comments | Create New Account
Comments belong to whoever posts them. Please notify us of inappropriate comments.
A proposal
Authored by: kg on Sunday, December 09 2012 @ 01:20 AM EST

To start out with, the FDA has a very difficult role, as you've pointed out. However, the delays forced by the system pose a greater danger to public health than might be thought.

The problem is that the FDA is turning into the TSA of the medical industry. In her official bio, the Commissioner is quoted as saying, "A strong FDA is an agency that the American public can count on."

While I would be the first to admit there are certain safeguards necessary to prevent gross negligence, it seems the courts have that one pretty well tied up. Get sued for gross negligence, and you're in big trouble. No need for the FDA to be involved at all. Is the FDA involved in medical malpractice? Nope, that's handled by the courts.

We're seeing an increase of cases where the FDA is dealing with conflict of interest. Officials should recuse themselves if they have any connections to a company whose products they are evaluating. Including if they've ever gotten a research grant from them, if a relative works there, etc. And let's put it under the judicial branch. Create a special court system that evaluates violations of public safety rather than forcing innovators to prove that their products are safe before bringing them to market.

That would encourage legitimate innovators, while punishing those who do not follow industry guidelines. Sure, it would hand it over to the lawyers and their fees, but it would be much better than having an opaque and autocratic agency that flexes its muscle just because it can.

Disclosure: I've worked in the medical device industry, primarily in product marketing, and was also involved with new product development.

---
IANAL
Linguist and Open Source Developer

[ Reply to This | Parent | # ]

what's your alternative?
Authored by: Anonymous on Sunday, December 09 2012 @ 09:17 PM EST
The basis of your argument is that there is great harm
from off label uses. Where is the data to support this position?

[ Reply to This | Parent | # ]

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