The Trump administration passed a new law that people with a life threatening illness (wharever that means) can use a drug without FDA approval if the drug has completed at least phase 1 FDA testing.
I think this means there is no difference because the FDA approves most compassionate use requests and the drug/device still needs to agree to provide the thing. I assume doctors will still go through their IRB (Institutional Review Board, I think), but I am not clear on that.
Some claim that this reduces FDA authority to protect people.
What I find “amazing” is that healthy people with nothing wrong in their bodies pass laws and rules for people that are constantly being bombarded with health problems. They know best [joke but not funny] what is best for us.
I agree with you. That is totally inappropriate. It is, unfortunately,analogous to men making decisions about women’s bodies. It is also one more example of assuming that stupidity comes with mobility problems.
What the Trump admin did was cut the red tape and endless forms needed for the FDA “expanded access” program. It gets the medication into the hands of the patient much, much faster.
While the “expanded access” program was a good idea in spirit in the real world the paperwork was overwhelming and the delays were simply impossible.
Hopefully this newest version will actually provide the access needed for people with no other options. Remember, it doesn’t change the fact that for expanded access the patient has to, basically, be terminally ill.
Did they really make anything better? After all, the FDA approved 99 percent of the cases, and doctors could give the drug first and do the paperwork later. It does not seem to me that anything is better.
I think you meant to say we disabled people “can” try a drug that’s not fully approved. If a drug is available in Europe or Canada, but not approved here, we can try that medication. The Trump administration says we can try these drugs and our insurance carriers have to cover the costs. This a huge win for us.
He also pushed through the anti-discrimination law for genetic disorders. Meaning my son cannot be denied life insurance coverage even though I have a genetic disorder that could be passed to him. Another big win for the Ataxia community.
I read the text of the bill and I did not see anything about insurance being required to cover drugs approved in any other countries. I also did not see anything about anti-discrimination for genetic disorders, though I like that concept, too. You are correct that I meant to say that terminally ill people CAN access pre-FDA-approved drugs. I corrected my original post. Those terminally ill patients will probable have to pay for their own drugs, though, and the manufacturer will not have to make the drugs available. It still looks to me that the bill really does very little for us or anyone. Thanks for correcting the original error. I’d really like to be wrong, so if you can point me to the other stuff, I’d appreciate it,
You are right about what you said, physically they may be healthy, but that doesn’t mean mentally they are all there. In England we have a saying, a sandwich short of a picnic, for all NON BRITS, it means that I doubt what comes from Mr. T’s mouth and his admin… the sooner they rid, the better. before he makes more damage…The whole NON EXISTENT safety net in the American society and INSURANCE says it all…litigious obsessed, no common sense and if you are ill, you MUST still work(I don’t know how mentally disabled manage)…I personally don’t take any meds, for my condition as they are NONE…yet but a guinea pig I ain’t…
I’m sorry Ladybird, although your comments may not be far from the truth, and some of our American friends may well agree, some of your words are verging on being inciteful and political and not appropriate in the group. And to be fair, here in the UK, there are plenty of disabled people disgruntled by the system for one reason or another. xB
Point taken and noted. Personally, I feel lucky in all this bad luck, that I am a half Brit and I am grateful for small mercies, my daily living allowance, my motability car…AND MUSTN’T LOOK OUT FOR A JOB. as others NOT so lucky (and nobody cares if they CAN work, pot luck) are burdened with extra, as they have NO income, as NO job…You all have my admiration, how you can survive…In Britain, we have a safety net, although have to fight for it hard…no hard feeling to all who DON’T AGREE WITH ME, in future I’ll stick to the condition, but if you think about it deeper the initial comment is inviting POLITICS…
Thanx 4 clarifyng…Ar4 u also Hutchÿ10?I might have mentioned: I contacted the company and they said they will contact me in a few months. Will I ever hear from them??xoN
If it’s OK, I would like to add my personal two cents here. As for politics, I can’t see how much is going to change. So I keep my thoughts regarding that to myself and just try to cope as best as possible. And yes, I do have my thoughts! All I know is that I really enjoy coming here because I learn some things that I would never know about. And for that I say thank you.
I’m sorry Ladybird, although your comments may not be far from the truth, and some of our American friends may well agree, some of your words are verging on being inciteful and political and not appropriate in the group. And to be fair, here in the UK, there are plenty of disabled people disgruntled by the system for one reason or another. 
xB