This right here. People move cross country or even internationally for a chance to be in the 1 hospital who is running a trial for some non-proven drug for their disease
Being able to get the drug wherever you are in the U.S is a good step, and every patient/doctor can decide if they want to try it
That's incorrect. Biogen can't legally sell you the drug unless it's been approved by the FDA or they use one of the specific exemptions like doing a drug trial.
Doctors can (and do) prescribe drugs for off label usages. There's nothing "illegal" about it.
The reason they don't do that more commonly is malpractice lawsuits and insurance companies don't like to cover off label prescriptions.
An excellent example of this: Medical Marijuana. Not FDA approved for almost anything and the only reason it's "illegal" is because of federal DEA classification.
So long as it's not listed as having any therapeutic effects, you can fairly freely buy any non-controlled substance.
Hang on, so I could totally sell off-patent insulin in America if I wanted to with a “not for therapeutic use” label? How do all those people keeping dying “because they couldn’t afford insulin” then? Feels like someone would capture the cheap end.
The issue is getting that off label insulin distributed. Insulin must be refrigerated which really makes distribution difficult. A pharmacy isn't going to store it in their refrigerators and stores aren't going to plop it down next to the milk.
Then, of course, you run into the risk that you get sued anyways by current insulin manufacturers for patent violations (good luck with that!).
Oh, and you also run the risk that someone takes your insulin and sues you for a bad reaction. With FDA approval, there's a much lower legal risk.
And finally, after you setup your insulin product, you simply run the risk that nobody uses it because it's off label and their doctors didn't prescribe it.
Oh, and for certain, your insurance will not cover it at all. So, bunch of risks with minimal rewards. Still completely legal. Can be done doesn't mean will be done.
Insulin is a FDA approved substance with therapeutic properties. How you label it is irrelevant.
You can't sell heroin with a "nutritional supplement"label either.
If a substance has no classification(neither controlled nor therapeutic) however, like water for example; you're free to sell it, to treat dehydration, or put a homeopathy label on it and sell it to cure cancer if you prefer.
Right, but that's not the point. The point is you are claiming that it'd be "illegal" for biogen to sell it. It's not because it's not a controlled substance.
Biogen won't sell it, but that has little to do with the legality of selling it and everything to do with the fact that they want insurance money and to market this.
That's not how that works. If Biogen tried to sell unlabelled bottles of aducanumab, the FDA would come after them in a heartbeat.
Picture the judge in the court case: "So, you developed this new molecule that never existed before, spent years testing it to treat alzheimer's, there's been hundreds of news stories about it, there is no other reason a consumer would buy it, and it costs $50k, but you expect the court to believe you didn't think it was being sold as a treatment?"
Why should Biogen be able to sell their drug? It hasn't been shown to work, it is for all intents and purposes at this point in time, snake oil.
Should Biogen be able to continue research and studies, sure, but they shouldn't be able to sell it until they have proof that it actually improves someone's life instead of having some effects on a possible bio-marker.
Being able to get the drug wherever you are in the U.S is a good step, and every patient/doctor can decide if they want to try it