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Getting a medication approved by the FAA

Old 12-06-2019, 12:49 PM
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Default 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?
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Old 12-06-2019, 01:14 PM
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Originally Posted by BigTime View Post
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?
If you’re at an ALPA carrier, my first phone call would be to AMAS for guidance.

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.
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Old 12-06-2019, 02:34 PM
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Originally Posted by BigTime View Post
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?
Depends on the medication AND the underlying condition. There are MANY FDA approved medications that will NEVER be approved for flying. But if the underlying condition is not an issue, then the issue becomes whether or not that medication itself causes you to be impaired flying. If it doesn’t it is simply a matter of convincing the FAA of that fact. Depending on the medicine that can either be quite simple or totally impossible.
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Old 12-06-2019, 09:22 PM
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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.
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Old 12-07-2019, 03:34 PM
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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.
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Old 12-07-2019, 07:21 PM
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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.
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Old 12-13-2019, 06:37 AM
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Well, fortunately it's not my only option. If need be, I can get switched to a different med. This one just seems to be more effective according to my Dr.
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