4 ms·

Do you think it is feasible to allow some kind of voluntary FDA opt-out for individuals, in extremely limited cases? I find myself wondering what I would want

Do you think it is feasible to allow some kind of voluntary FDA opt-out for individuals, in extremely limited cases? I find myself wondering what I would want to do if I were in a similar situation: long-term, treatment-resistant illness, pain and inevitable death. At this point in my life, I think I would be okay saying "okay nothing is working. I volunteer to be an experimental subject - and if I die, please absolve anyone working to cure me from punishment."

maxerickson 10y ago
It exists: http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194958.htm http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194958.ht...
- mentalpiracy 10y ago
  Thank you for teaching me something new today.
  - ceejayoz 10y ago
    There's a bunch more info at http://www.fda.gov/ExpandedAccess http://www.fda.gov/ExpandedAccess.
- dogma1138 10y ago
  There is also an orphan drug classification which has a reduced approval process which is intended for very rare cases or cases where clinical trials are simply impossible to orchestrate due to the life expectancy at the clinical stage.
openasocket 10y ago
Interesting fact: a doctor can prescribe you any drug for any reason, regardless of what the drug was meant for, subject to a couple restrictions. So, if you are in such a terminal situation, and some studies have shown drug X, normally used to treat some other disease, could help people with your disease, the doctor can prescribe it to you even if the drug hasn't been FDA approved for that purpose. This is intentional: it allows doctors to use cutting-edge research and don't have to wait years for FDA approval. There are restrictions, of course. First, if a doctor start prescribing opiates to every patient s/he'll probably get a call from the DEA :). Second, insurance companies may refuse to pay for experimental treatments. And third is potential malpractice liability, but making sure the patient has informed consent can limit that. And this all only applies to drugs that are already FDA approved, just not for your specific use case. I should point out the only reason I know this is from an article about some drug companies that have been accused of encouraging doctors to use their drugs for non-FDA approved purposes to boost sales. So I may be missing some key details here.

maxerickson 10y ago

It exists: http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194958.htm http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194958.ht...

mentalpiracy 10y ago
Thank you for teaching me something new today.
- ceejayoz 10y ago
  There's a bunch more info at http://www.fda.gov/ExpandedAccess http://www.fda.gov/ExpandedAccess.
dogma1138 10y ago
There is also an orphan drug classification which has a reduced approval process which is intended for very rare cases or cases where clinical trials are simply impossible to orchestrate due to the life expectancy at the clinical stage.

openasocket 10y ago

Interesting fact: a doctor can prescribe you any drug for any reason, regardless of what the drug was meant for, subject to a couple restrictions. So, if you are in such a terminal situation, and some studies have shown drug X, normally used to treat some other disease, could help people with your disease, the doctor can prescribe it to you even if the drug hasn't been FDA approved for that purpose. This is intentional: it allows doctors to use cutting-edge research and don't have to wait years for FDA approval. There are restrictions, of course. First, if a doctor start prescribing opiates to every patient s/he'll probably get a call from the DEA :). Second, insurance companies may refuse to pay for experimental treatments. And third is potential malpractice liability, but making sure the patient has informed consent can limit that. And this all only applies to drugs that are already FDA approved, just not for your specific use case. I should point out the only reason I know this is from an article about some drug companies that have been accused of encouraging doctors to use their drugs for non-FDA approved purposes to boost sales. So I may be missing some key details here.