new law for terminally ill
Trump just signed a law giving terminally ill patients access to experimental drugs ! Isn't that great ?
That's actually been available for some time... need to see how this will extend things, if at all...
We have a somewhat similar mechanism in Canada under the Special Access program. or SAP.
It was not a law before ! It's great for Americans.
Hi sounds like very good news to me. I don’t know if it applies to the UK? Maybe someone here does?
Thanks for posting this information.
No, unfortunately its only for Americans .
Hi ikahan thank you for letting me know. I hope we go this way in the future.
Who's paying for these drugs?
Probably the drug company and it's a good law
That is good news. Especially for people who have no other hope. I never could understand why someone couldn't get an experimental drug to help them if nothing else presently available could help. Sensible.
Is it like a “hold harmless” agreement? Do you have any specific verbiage to pass along?
Yeah.. thats's what I understand, it removes liability from doctors and drug companies, but does not obligate drug companies to provide drugs at no cost...
I think it will open new avenues and doctors may be more keen to use 'off labels' drugs, since they will have liability protection...
I hope its a positive, but we need to see...
It is only for terminal patients, considered experimental.
If people are truly terminal, I'm sure some will want to try these experimental drugs since it would be their last hope. At some point all drugs were "experimental", some made it to mainstream, some did not.
FDA on the topic
This ‘Right to Try Act’ appears to essentially give people with limited and dwindling options the right to use untried and untested medication within the reality that they have nothing to lose if the drugs don’t prove to have efficacy.
It’s not as far as I can see, the right to be given difficult to obtain meds rather those that are still in experimental stage.
Once the terminal stage is reached (definition in the U.K. is life expectation under 6 months), it sounds eminently sensible to me.
As Chris says, the compassionate route has been available for some time. Not sure how this is massively different except it puts it into legislature.
This is how it differs from the previous compassionate route, according to article link Chris posted:
"The new Right to Try act allows patients with life-threatening diseases to bypass the FDA's application process for "compassionate use" of experimental drugs. Patients seeking access to "investigational drugs" now need only the approval of their physician and the drug manufacturer. The new bill protects doctors and companies from the legal risks of allowing unapproved treatments unless they intentionally harm a patient."
And gives political fodder
cllady , it's still a good law that can only help people !
It's interesting that the American Cancer Society opposed this bill (according to article link chris posted). I wonder why?
I’m guessing money, but could be I’m just bitter at the moment from our ongoing insurance and cost battles 🙄
Letter of Concern.
This bill, weakens the FDA and covers drug companies for all liabilities... the impediment frankly, is money, not the compassionate care system...which has worked well is since 2009...
I’m hoping never to need the law, but am grateful we have it. Thanks. Sally
If it gives people hope then it can't be a bad thing as long as its not false hope.
Not thinking it will change much, if anything...
"the FDA has systems to expand access for very sick patients, which are known as expanded-access or compassionate use programmes.
“Emergency requests for individual patients are usually granted immediately over the phone and non-emergency requests are generally processed within a few days,” Dr Scott Gottlieb, the FDA commissioner, said last year.
A study by FDA researchers concluded that expanded access requests for 9,000 experimental drugs were approved 99 per cent of the time between 2005 and 2014.
What do supporters say?
Supporters say that the new bill gets rid of the application requirements of the FDA’s expanded access program, and that doing so will save patients time.
Actually it is not a "law" just an executive order which can be cancelled any time by the same person. Only the US Congress can pass a law.
Someone knows her Civics!! And this order can be changed by the next President as well......as is seen by the disappearing regulations on the environment.
On March 21, 2018, the House of Representatives passed a right to try bill, sending it to the Senate for consideration.
On May 22nd, the Senate passed the bill, and it was then sent to the President's desk for his signature.
On May 30th, President Trump signed the bill into law.
Looks like a law to me... 👁
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