Getting a medication approved by the FAA
#1
Gets Weekends Off
Thread Starter
Joined APC: Feb 2010
Position: Cessna 150
Posts: 105
Getting a medication approved by the FAA
My doctor put me on a medication that has been approved by the FDA for 2.5 years, but has not yet been evaluated by the FAA. If approved, it would require a special issuance medical certificate.
I fly for a 121 airline, but have been on a leave of absence for a couple months and have not had any adverse reaction to the medication. How would I go about getting the FAA to approve this medication?
I fly for a 121 airline, but have been on a leave of absence for a couple months and have not had any adverse reaction to the medication. How would I go about getting the FAA to approve this medication?
#2
My doctor put me on a medication that has been approved by the FDA for 2.5 years, but has not yet been evaluated by the FAA. If approved, it would require a special issuance medical certificate.
I fly for a 121 airline, but have been on a leave of absence for a couple months and have not had any adverse reaction to the medication. How would I go about getting the FAA to approve this medication?
I fly for a 121 airline, but have been on a leave of absence for a couple months and have not had any adverse reaction to the medication. How would I go about getting the FAA to approve this medication?
If you’re not ALPA, find an AME that isn’t just a medical certificate factory. Do your research and find one that will advocate for you. I had a minor, but grounding (possibly permanently) medical issue about 15 years ago. My AME took the reins and took care of everything, continuously called me to follow up and keep me updated. He essentially held my hand through the whole process and did all the dirty work. My personal interaction with the FAA was minimal. A few months later I was back in the air without a single issue since. Not all AMEs are created equal. My guy isn’t cheap, but he is worth the money when poop hits the fan blades.
If all else fails, contact an aviation attorney specializing in medical issues. AOPA might not be a bad place to start.
Last edited by TOGALOCK; 12-06-2019 at 01:38 PM.
#3
My doctor put me on a medication that has been approved by the FDA for 2.5 years, but has not yet been evaluated by the FAA. If approved, it would require a special issuance medical certificate.
I fly for a 121 airline, but have been on a leave of absence for a couple months and have not had any adverse reaction to the medication. How would I go about getting the FAA to approve this medication?
I fly for a 121 airline, but have been on a leave of absence for a couple months and have not had any adverse reaction to the medication. How would I go about getting the FAA to approve this medication?
#4
Banned
Joined APC: May 2014
Position: Tom’s Whipping boy.
Posts: 1,182
There are many fairly benign drugs that would not adversely affect your performance at the controls, but are not approved because of the underlying condition they are typically prescribed for.
If that’s not the case for you, try contacting the manufacturer for help with FAA. It’s a long shot and might take a long time, IF, they would help.
AMAS will also serve non ALPA pilots, corporate pilots, etc. They are not cheap.
If that’s not the case for you, try contacting the manufacturer for help with FAA. It’s a long shot and might take a long time, IF, they would help.
AMAS will also serve non ALPA pilots, corporate pilots, etc. They are not cheap.
#5
Gets Weekends Off
Thread Starter
Joined APC: Feb 2010
Position: Cessna 150
Posts: 105
Thanks
Thanks for the reply. The medical condition is not something that would keep me from flying, and I don't think the medication is either, it's just fairly new to market (2 years) and hasn't yet been evaluated by the FAA. I haven't experienced any side effects from it at all. I just wasn't sure how to go about getting the FAA to evaluate it so it can be approved. I spoke to my AME's assistant and they didn't seem to be very helpful, but then again, he's one of those medical certificate factories mentioned above. Maybe I'll find a new AME.
#6
Gets Weekends Off
Joined APC: Dec 2017
Position: Retired NJA & AA
Posts: 1,907
I'm grounded by a medication that's been FDA approved since 2013. It's in the family of SGLT2 inhibitors that are used by diabetics. I've had no side effects. Trying to get the FAA to approve a medicine that's only been out for a few years is like trying to move a huge bureaucratic mountain. AMAS deals with the FAA many times per week, I would spend the $$$ and talk to one of their Docs about your options. The chances are probably very slim of getting approval.
Insulin Dependent Diabetic Pilots having been flying commercially in Canada since the 1990's, and also in England. Insulin Dependent Private Pilots have been able to hold a Class 3 in the USA since the mid-90's. Yet the FAA only in the past few weeks finally relented and will now give Class 1's to those pilots. They didn't want to but DOT was facing numerous lawsuits by Diabetic Pilots and I believe crammed it down the FAA's throat. The FAA medical bureaucrats are extremely risk averse. As recently as 2-3 years ago the late Sen. John McCain was pushing the FAA hard to approve a medical for an Arizona Diabetic Pilot, and they would not relent even under duress from a powerful Senator.
Good luck, no harm in trying thou.
Insulin Dependent Diabetic Pilots having been flying commercially in Canada since the 1990's, and also in England. Insulin Dependent Private Pilots have been able to hold a Class 3 in the USA since the mid-90's. Yet the FAA only in the past few weeks finally relented and will now give Class 1's to those pilots. They didn't want to but DOT was facing numerous lawsuits by Diabetic Pilots and I believe crammed it down the FAA's throat. The FAA medical bureaucrats are extremely risk averse. As recently as 2-3 years ago the late Sen. John McCain was pushing the FAA hard to approve a medical for an Arizona Diabetic Pilot, and they would not relent even under duress from a powerful Senator.
Good luck, no harm in trying thou.
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