Court rules FAA antidepressant denial 'arbitrary'

The June 27 decision from the U.S. Court of Appeals for the District of Columbia Circuit stops short of ordering the FAA to issue a medical certificate to petitioner Michael Solondz, but the court (which is the first stop for those challenging a special issuance denial) declared that the FAA's denial of Solondz's special issuance application was "arbitrary and capricious," the key phrase in a narrowly defined legal standard that guided the court's review. "The FAA's thin and variable explanations in the Final Denial Letter and in its brief on appeal do not satisfy that standard," the court wrote.

The case was decided 15 years after the FAA approved the first four commonly prescribed antidepressants for use by medical certificate holders, though the process of qualifying was and remains complex and time-consuming, not to mention expensive. Applicants must navigate the special issuance process, including at least six months on the ground taking the same dose of the same medication with "no symptoms or side effects," the FAA notes in its guidance for pilots who are prescribed selective serotonin reuptake inhibitors.

While the FAA has made progress, adding new medications of various classes to the list of antidepressants that can be approved through the special issuance process, the pace of progress has not come fast enough for advocates concerned about the safety implications of pilots being so strongly discouraged from risking their livelihood to seek the treatment they need. Federal Air Surgeon Dr. Susan Northrup has an ongoing dialogue with AOPA and other advocates on the issue.

At a 2022 roundtable hosted by AOPA at EAA AirVenture Oshkosh, the chief FAA medical officer acknowledged the challenge of a system that discourages pilots from seeking care, reported on progress including the addition of new staff with mental health and pharmaceutical expertise, and drove home the message that many mental health conditions are not necessarily disqualifying. In 2024, the Mental Health and Aviation Medical Clearances Aviation Rulemaking Committee made 24 recommendations for further work, including the creation of a non-punitive process for certificate holders to disclose mental health conditions. Congress is also applying pressure to reform, with a bill now under consideration that would require the FAA to expand the list of approved mental health medications.

Solondz was working as an airline pilot when his father died in 2018, followed by his father-in-law the following year. He took extended medical leave and, in August 2020, began taking Remeron (mirtazapine in generic form) to treat anxiety. While he had been initially prescribed another medication that the FAA does consider for approval, Solondz found it had unwelcome side effects, including dizziness and drowsiness, while Remeron, taken at night, was effective and without those side effects. He applied for a special issuance first class medical certificate in August 2021, which the FAA denied a month later, followed by additional denials in 2022 and 2023, and a final denial in 2024, the court noted in its 18-page decision.

''We conclude that the Final Denial Letter was arbitrary and capricious because the FAA has not adequately articulated a rationale for its policy categorically barring pilots under treatment with mirtazapine (Remeron) from Special Issuance medical certification."

The record before the court included administrative records and a brief from the FAA opposing the pilot's petition, as well as oral arguments before the court, none of which, the court wrote, "offer a reasoned explanation why the Administration categorically disqualifies pilots taking mirtazapine from obtaining conditional medical certification through the Special Issuance process. The six-month waiting period and individualized medical assessment are apparently designed to keep the skies safe by identifying pilots experiencing side effects of prescribed medications that could interfere with pilot performance. And there are, no doubt, medical treatments that the FAA may categorically conclude are inconsistent with safely piloting commercial aircraft. But the agency has yet to explain why a pilot taking mirtazapine at night at a dosage that apparently does not produce in him the drowsiness clinically observed in other patients is barred from using the demanding Special Issuance process to seek to establish to the Federal Air Surgeon's satisfaction that he suffers no aeromedically significant side effects."

Remeron is a tetracyclic antidepressant, part of a class of drugs that the FAA has not yet allowed for medical certificate holders. The class has a distinct pharmacological profile from the SSRIs and other classes of pharmaceuticals used to treat mental health conditions that the agency has approved, though the expected side effects are very similar to those associated with FAA-approved drugs.

The court took the agency to task for failing to explain a rationale for disallowing the prescription at issue:

"The key missing piece of information here is how the agency determined that those other medications, which apparently also carry some risk of drowsiness in some people, need not bar the pilots taking them from consideration for Special Issuance whereas mirtazapine does impose a categorical bar," the court wrote. "We do not—and cannot—substitute our judgment about the content of these studies for the FAA's own. But it is our duty to identify material gaps in the agency's articulated rationale."

The court found that the medical studies of mirtazapine (Remeron) justify triggering the special issuance process, in which the outcome of each application is determined by FAA aeromedical staff, not the aviation medical examiner. The mandatory six-month waiting period to confirm medication stability and individual scrutiny of the applicant's records "afford the FAA the opportunity to determine in each individual case whether, for example, nocturnally administered mirtazapine caused sedative effects after the acute treatment phase. But the agency's position implies that it believes the risk of somnolence from mirtazapine is so severe, persistent, or unpredictable that the guardrails within the Special Issuance process, as called for by the Antidepressant Protocol, are insufficient to protect aviation safety. If that is the case, the FAA must articulate and support its reasoning. We cannot fill in the blanks by supplying a reasoned basis for the FAA's policy that the agency itself has not given," the court wrote.

Solondz, who petitioned the court to review the FAA's denial in November, issued a written statement through his attorneys on June 30:

"This decision just confirms what I've known all along: that my choice to self-ground and address my health concerns, ensuring I wouldn't jeopardize the flying public, was the right decision at the time. I sincerely hope the FAA will take the court's guidance to heart, do their part, and issue my certificate without further delay."

The court directed the FAA to further explain its denial of Solondz's application, and while it did not direct a specific outcome, the judges told the agency "it must take care to avoid 'offer[ing] an explanation for its decision that runs counter to the evidence' before it," citing a legal precedent on that point.

Solondz, in his written response to the ruling, also reflected on how his case may affect fellow pilots:

"Over the past few years, mental health in aviation has, quite rightly, moved into the spotlight. I believe we're at a crossroads in this industry. Rather than focusing on what was, I'm choosing to envision what could be. I deeply hope that pilots are not only encouraged but also enabled by the FAA to get the help they need. The public deserves safe pilots, and pilots deserve a system that unequivocally supports their well-being and safety."