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Anyone have experience with Compassionate Use?

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Anyone have experience with Compassionate Use?

Postby Alone Again » Tue Nov 13, 2018 9:27 pm

I participated in a clinical trial 2 yrs ago. In decades, this was the only medication I used that had a highly positive effect on my Major Depressive Disorder. The drug in question was submitted to the FDA for final approval 2 months ago and was placed on the Compassionate Use list.

Saw my psychiatrist today and asked her to request early access to the drug. She knows nothing about 'Compassionate Use' or FDA procedures and is resistant to anything with which she is unfamiliar. She offered several lame excuses and then sent off an email to her boss, telling me that she might not be allowed to request the drug for me.

I am certain that the drug will be approved but I've already waited 2 years knowing it's out there and can help me. The approval process could take another 2 yrs so I am not willing to give up on requesting the drug now.

I'm wondering if anyone here has experience with requesting and/or gaining pre-approval access to medication. If so, I would love to hear your story. I'm trying to dig up as much information as possible so that if I receive the anticipated 'we can't help you' response, I will be in a position to intelligently debate them.
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