Re: Roxanol being pulled from the market by FDA Originally Posted by elkpark
It's been the law for a very long time, and certainly no secret, that you can't sell drugs that aren't FDA approved in the US. As I understand the brouhaha, no one is saying there's anything wrong with the drugs themselves, just that the manufacturers haven't gone through the required process to get FDA approval. Why should the standard for these drugs be different than the standard for any other drug? If it was some honest mistake that the manufacturers didn't realize they needed to go through the FDA process (very hard to imagine!!), they can fix that now -- better late than never.
If this was aimed at only one or two manufacturers, I would think that perhaps they were just negligent about filing. But when it's nine companies, then I think there's something else going on.
At least with the majority of actively dying Pts I see, capsules or 20mg/5ml concentrations are a long way from being good substitutes.
Interesting, too, that the FDA had a lawyer commenting on what are good substitutes for the pulled meds.
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