Wednesday, October 27, 2010

How to Get Around FDA Regulations - Legally!

It can be done and now that the Supreme Court has given its stamp of approval. The Supreme Court has now stated that it is o.k. to import drugs from a non-approved source foreign source and use them for their intended application. I never thought I'd see the day, but it has happened.

Oh, before I go, I forgot to mention the one little restriction: this only applies if the drug are intended for a court-ordered execution!

Apparently being concerned about the purity of the chemicals, their storage, etc. is just not an issue if you are being sentenced to death. If you've worked in an FDA regulated environment, the reasoning in the Court's Order is going to get you like fingernails on a chalkboard:
"There is no evidence in the record to suggest that the drug obtained from a foreign source is unsafe."
Try telling that to the FDA inspector next time they audit your facility and watch them die laughing. Sorry, if you are making a regulated drug/device, the burden of proof is on you to show that it is safe - the presumption is that it is not safe, even as the Supreme Court here attempts to reverse that.

Obviously this won't change anything except for the suppliers in this ultrasmall niche market. And it certainly was a creative attempt by the lawyer to delay the execution, but I imagine that more than a few people at the FDA heard about this and were aghast as it really was a complete reversal of their regulations.

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