The FAA has to give better reasons for denying a former airline pilot a medical for taking an unapproved anti-depressant drug. In a decision released June 27 by three judges of the U.S. Court of Appeals for the District of Columbia Circuit’s, the agency was told to provide more solid rationale for its categorical ban on the drug mirtazapine. Michael Solondz was put on Lexapro for anxiety in 2018 after going through a rough patch with the death of his father. That drug is on the FAA’s list of conditionally approved anti-depressants, but it caused unwanted side effects for Solondz. His doctor switched him to mirtazapine and it effectively treated the anxiety without the side effects. But mirtazapine is not on the FAA’s list of conditionally approved antidepressants and it has blocked Solondz from restoring his medical. The judges stopped short of telling the FAA to approve the medical but they want a better explanation of why the drug that doesn’t work for Solondz is approved and the one that does work for him can’t be.
The judges noted that even if Lexapro worked for Solondz, there was no guarantee he would have gotten his flying privileges back. Pilots must go on the conditionally approved drugs for six months to find out if they, like Solondz, experience side effects. The judges appear to believe that the same consideration should be given the drug that ended up working for Solondz. “The Administration makes case-by-case medical decisions regarding the fitness to fly of anyone taking a conditionally approved medication, but it will not consider whether Solondz or any other individual pilot taking mirtazapine is free of side effects and can fly safely,” the judges said. “The agency has failed to explain why it categorically disallows medical certification to all pilots who take the medication that Solondz was prescribed and finds beneficial, rather than permitting conditional approvals if merited under the agency’s robust medical clearance process.” They remanded the FAA’s denial until it comes up with that explanation.
AOPA says the case may have implications for others battling the FAA to regain their certificates after being successfully treated for mental illness. The perception among pilots is that any admission of mental health issues will result in their tickets being pulled, so many continue to fly without treatment. The agency is working on expanding access to treatment for pilots without compromising safety that will include a way for pilots to disclose their mental health issues without necessarily jeopardizing their certification and livelihood. Congress is also working on a bill that would expand the list of potentially allowable drugs. It’s not clear if mirtazapine is on that list.
" Judges want to know why some effective antidepressants can’t be used by pilots"
It’s none of their business.
Period.
Incredibly thoughtful response, Arthur.
In many parts of Europe, Mirtazapine is a (commonly) primary health care doctor prescribed medication that does not require a psychiatric evaluation. It is given for anxiety or temporary posttraumatic stress and basically handed out like candy. With limited effectiveness, it causes rather surprising side effects, however in comparison with other meds, its fairly harmless.
Unfortunately, todays environment/ world is causing a bit more anxiety, which requires treatment and that trend is trajecting upwards.
We are starting psychoactive drug treatments in children these days, blissfully unaware about later consequences and mental- development related issues down the road.
Unless the FAA starts to find a more reasonable way of dealing with the issues of blanket denials, there won’t be a whole lot of starry eyed, white teeth smiling superpilots available, 20 years from now.
Last but not least, admitting the (even temporary) suffering from depression requires courage, as society remains ignorant and incompetent on the subject. Maybe taking someones livelihood away from them, for having depression treated is not really beneficial. From what it looks like, we’d rather not see the issue and willingly accept the status quo of leaving depression undiagnosed and untreated.
Of course, the first answer above is a bunch simpler and does nor require any rational thinking or knowledge.
This is what popped up on a google search of the drug: * Dosage: The recommended starting dose for adults is typically 15 mg once daily at bedtime due to its sedative effects. The dosage can be adjusted by a healthcare provider up to a maximum of 45 mg daily.
Defense attorneys can ask, but local Judges are supposed to rule based on the law and what’s presented before them. That’s why it’s literally “none of the business” of a local judge to do investigative work for the defense.
Courts are not fair and impartial if the judge is literally working for one side.
Pages 11 and 12 of the Court’s ruling explain exactly why this medical denial IS the Court’s business and the specific legal precedents that give it the authority to demand that the FAA justify why its decision - in this case - was not arbitrary and capricious.
We have a local pilot who was attempting to pursue a private certificate. He experienced a death in the family and was prescribed an anti-anxiety med (Paxil) for a short period of time, which by his admission, he did not take. It took 6 years and over $15,000 of medical testing to receive a special issuance. Fortunately he had enough patience, time, and money to persevere and he is now a certificated pilot.
I’m trying to wrap my head around the need for such medical oversight and have failed to do so. BasicMed was a start, but it doesn’t go nearly far enough. If my personal physician is willing to fly with me, then that should be enough for the FAA, period.
Let’s see the evidence that pilots are dying at the controls… yes, it has happened and will happen again, but the medical exam is unlikely reveal or prevent those sudden incapacitation conditions. The vast majority of us would never fly an airplane impaired or in a known unhealthy state. The those who fly regardless of their (un)health and in disregard of IMSAFE aren’t stopped by a regulation.
Just my 2 cents and my opinion is worth less than that amount…
Depends on the individual.
FAA’s position has been that depressed people may take actions when recovering (depression being characterized by lack of action, which isn’t good in the air either).
Like an STC, there is an approval process. If you fly your plane with a modification before it’s approved, then you’re in violation. If a drug is not yet on the approved list and you take it, you’re in violation as well. The underlying “is it safe this time” does not really enter into it if you knowingly are putting in MoGas in your plane or drugs into your system without full testing and approval.
It may be fine. But if FAA AeroMedical hasn’t reviewed it. it shouldn’t be allowed. So, it absolutely is their business.
I have to believe that there is more to this medico-legal story than has been reported. As paranoid as I was about maintaining my piddling non-commercial Third Class medical (pre-BasicMed), I can’t imagine that an airline pilot with a First Class would not have made dead-damn-sure the pills he was prescribed were “FAA approved”, for what that’s worth.
Then again, if you think getting an STC for Mogas is a byzantine process, try to imagine getting a drug on their approved list in your lifetime, much less for the brief time you might need it. The FAA forces us to prove a negative (that it is safe for a peculiar activity) when there is ample evidence that it causes no problems in long-haul truckers, oil-rig roustabouts, politicians, and judges.
Sour.dough, do you know who has a greater impact on your life than an airline pilot? Your Congress-critter. Why don’t they have to pass a first-class medical to pilot our Ship of State? The consequences of their actions are far more consequential to far more people than a plane-load of pax.. And that goes double for hard-partying ex-Fox employees in globally-consequential positions.
His post reflects nothing short of angry old man sticking it to everyone. Pure ignorance. I believe he only types to find himself doing something.
All arguments, no matter how eloquently formulated are lost effort.
A few points of clarification on Arthur’s post. First, it was not a single judge, but 3 judges. Second, the judges are not local. They sit on the second highest court in the country behind only the US Supreme Court. Third, they’re not saying that the FAA is wrong to deny medicals for those taking the drug only that they need to justify why one drug and not the other. Fourth, at least for now each of us has the right not to be subject to federal regulations that are “arbitrary and capricious.” It’s still very much the duty of our judicial system to ensure that’s the case.
Fun fact: Airlines would never know. But even if they did and miraculously opted to share this information as a form of liability disclaimer…
“We would like for you to acknowledge that, due to the antiquated nature of medical certification in the United States, your airplane may be operated by a person or persons under the influence of psychoactive drugs, to include OTC medication and/or undisclosed antidepressants not reported to us. XXY Airlines will not be held responsible/liable for incidents or accidents resulting from this commonly accepted status quo of secrecy.”(Signature/ Date)
At least that would be honest and transparent, because the boohoo attitude some of the commenters show, makes it obvious that we are fostering the kind of secrecy.
Remember that for every single case of “pilot grounded due to wrong medication” who makes it to the news, there are 10 cases where that is not happening or kept secret. How many are taking medication or have access to otherwise prescribed meds and nobody will ever know.
Unless you do bloodtests prior to every flight, you have 0.00 opportunity to actually find out which substance may or may not be in the pilots system.
All the FAA has to say is that they are working from an “abundance of caution” and be done with it.
There ARE side effects and from what it sounds like those side effects are not easy to predict.
If this was through a lawsuit then yes it is the judges business. ALL regu.lations are subject at any time to a lawsuit. This one is obviously based on a legal challenge to the FFA regulatory decision. To NOT have acess to review of any regulatory decision is to allow the regulatory agency to do as it pleases. there is an important bit of the Bill of right concerning due process. ie you have tax as a right. Regulations are devised from an interpretation of law as written by congress (or then state / city equivalent as the case may be). The agency puts that into action. it is applied to an individual. the individual in this case feels it is wrong…as stated the drug " allowed" did not have a positive affect. Another di. the pistol lost hie privilege. so far so good. He (or she) sues stating that the regulation is erroneous. the court DID NOT AGREE but asked for justification of the banning of an effective treatment…upholding the right of due process. ie what is the REASONING behind the banning of that effective treatment. this is all very much so needed to make sure regulations do thier job ..ie make I the case flying safe…vs just following the letter of a regulation.
Another bit of information for all you “drugs have side effects folks…”. The single best indicator of side effects is whether they occur or not. So, one approach is require a 30 day no-fly period after a pilot starts a new medication and then assess for adverse effects. If none that affect pilot skills occurred after 30 days, then they aren’t going to happen.
I read that the judge simply ordered FAA to explain its policy.
USAF allows use of a very short-acting sleep aid by a pilot who has to maintain readiness, IF tests of it by the individual show it is tolerated.
IIRC a waiting period after taking it is required before flight, perhaps four hours.
IIRC FAA allows it with a waiting period of 12 hours.
zaleplon, which is sold under various brand names, usually Sonata in the US.
Waiting period to evaluate side effects is wise.
The judicial branch is there to settle disputes plain and simple. If there is a dispute, if someone is subject to an action by the government, they have due process rights guaranteed by the Constitution. Administrative judges are part of the deep state, my friend.
They’re not doing investigative work for the defense. The law cannot be applied capriciously. The judges are asking the FAA to explain their rationale ostensibly using a scientific basis. I bet the FAA doesn’t have a scientific basis. What that means for the ultimate disposition of the case is unclear, though. The court could allow them time to come up with a scientific basis for that drug, which would probably trigger an effort to do that for all drugs or risk more court cases, or time to create a policy that allows for individualized monitoring of side effects that applies to all drugs.
The law or regulations cannot be applied capriciously, and there are Constitutional issues such as equal protection under the law. For right now, all the judges are asking is for the FAA to explain themselves. If they can do that with a straight face, then the law isn’t being applied capriciously. If they can’t - and I suspect that’s the case here - it doesn’t mean the medical is going to be approved. It could simple mean the FAA gets time to write a scientific basis for that drug and possible other drugs, too, or come up with a policy that starts with individualized monitoring for each drug.
I think the primary issue here is that all psychoactive drugs have unpredictable side effects and react very differently for different people that take them. This is not the case for Tylenol, which is about the strongest thing pilots are allowed to take. There is a REASON for this. Aggregate data seems to demonstrate that psychoactive drugs are making the mental health crisis much worse, they may even be largely responsible for it. Regardless, by your admission they have unpredictable effects that should not be permitted in the flight deck. Our goal is safety, we need people to be predictable. Someone in a mental health crisis, medicated or not, should not be flying.
Not that I want to poke it with a stick or anything, but surely what the FAA’s attitude is boils down to – We cannot have happy pilots, and
We know better than medical doctors.
I get that after German wings 9525 (some of the first responders on the scene are till traumatised 10 years on) there should be a focus on pilot mental health. Punishing pilots who are open about their health does not seem to be the best way of going about it.