SI for airmen taking a REMS protocol medication

Craig

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Craig
Question for the AME's.... Does OKC have a process for evaluating for an SI, for someone that is on a REMS protocol medication, where things are stable and in maintenance mode, or would it simply be wasting time, money and most of all, an AME's time and effort with no possibility of getting the SI?
 
Craig, the drug has to be (1) approved for normal use by FDA, and (2) an FAA "expert" panel has to convene to evalute it's use in Aviation. I suspect that any REMS med is a REMS med for just that reason- no "normal approval", and even if it was, Unless there was a TON of demand, the FAA is unlikely to have held that panel...
 
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Thanks for the response and information. I kinda suspected that was going to be the way things are. Have already transitioned to the long term testing protocols at the earliest time allowed, so only have to have followups and testing every 6 months for the forseeable future. Guess that halts me from ever getting my medical back, unless the med gets taken off the REMS protocol.

Definitely bummed, but got to stay legal.
 
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