Special Issuance of Airman Medical Certificates to Applicants Being Treated With Certain Antidepressant Medications, 17047-17050 [2010-7527]

Agencies

• Federal Aviation Administration
• DEPARTMENT OF TRANSPORTATION

[Federal Register Volume 75, Number 64 (Monday, April 5, 2010)]
[Rules and Regulations]
[Pages 17047-17050]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7527]


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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 67

[Docket No. FAA-2009-0773


Special Issuance of Airman Medical Certificates to Applicants 
Being Treated With Certain Antidepressant Medications

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Policy statement; request for comment.

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SUMMARY: This policy statement is intended to serve as notice that the 
Federal Aviation Administration (FAA) will consider for a special-
issuance medical certificate applicants for first-, second-, and third-
class airman medical certification who are being treated for depression 
with one of four antidepressant medications. The FAA will evaluate 
affected applicants on a case-by-case basis and will issue certificates 
based on a medical finding that an individual's use of such medication 
will not endanger public safety.

DATES: This policy goes into effect April 5, 2010. Comments must be 
submitted on or before May 5, 2010.

ADDRESSES: You may send comments identified by Docket Number FAA-2009-
0773 using any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov and follow the online instructions for sending your 
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S. 
Department of Transportation, 1200 New Jersey Avenue, SE., Room W12-
140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket 
Operations in Room W12-140 of the West Building Ground Floor at 1200 
New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., 
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at 202-493-2251.
    Privacy: We will post all comments we receive, without change, to 
https://www.regulations.gov, including any personal information you 
provide. Using the search function of our docket Web site, anyone can 
find and read the electronic form of all comments received into any of 
our dockets, including the name of the individual sending the comment 
(or signing the comment for an association, business, labor union, 
etc.). You may review DOT's complete Privacy Act Statement in the 
Federal Register published on April 11, 2000 (65 FR 19477-78) or you 
may visit https://DocketsInfo.dot.gov.
    Docket: To read background documents or comments received, go to 
https://www.regulations.gov at any time and follow the online 
instructions for accessing the docket, or, the Docket Operations in 
Room W12-140 of the West Building Ground Floor at 1200 New Jersey 
Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through 
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Judi Citrenbaum, Federal Air Surgeon's 
Office, Office of Aerospace Medicine, Federal Aviation Administration, 
800 Independence Avenue, SW., Washington, DC 20591; telephone (202) 
267-9689; facsimile (202) 267-5200, e-mail Judi.M.Citrenbaum@faa.gov.

SUPPLEMENTARY INFORMATION: 
    Availability of the Policy Statement: You can get an electronic 
copy of this document using the Internet by--
    1. Searching the Federal eRulemaking Portal (https://www.regulations.gov);
    2. Visiting the FAA's Regulations and Policies Web page at https://www.faa.gov/regulations_policies or
    3. Accessing the Government Printing Office's Web page at https://www.gpoaccess.gov/fr/.
    You can also get a copy by sending a request to the Federal 
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence 
Avenue, SW., Washington, DC 20591, or by calling (202) 267-9680. Make 
sure to identify the docket number.

Background

    Under Title 14 of the Code of Federal Regulations (14 CFR) 
67.107(c), 67.207(c), and 67.307(c) and 67.113(c), 67.213(c) and 67.313 
(c), the FAA generally considers a diagnosis of depression and use of 
psychotropic medication medically disqualifying for applicants for FAA 
medical certification. Disqualifying medication generally includes all 
sedatives, tranquilizers, antipsychotics, antidepressants (including 
selective serotonin reuptake inhibitors (SSRIs)), analeptics, 
anxiolytics, and hallucinogens. Aviation Medical Examiners (AMEs) defer 
medical certificate issuance for any applicant with a disqualifying 
medical condition, including any applicant who reveals on a medical 
certificate application usage of psychotropic medication for treatment 
of depression.
    Under 14 CFR 67.401 the Federal Air Surgeon may, at his discretion, 
authorize special issuance of airman medical certificates to applicants 
who are disqualified under the certification standards set forth in 
subparts B, C, or D of part 67. The FAA, however, has long considered 
the use of a psychotropic medication for treatment of depression as a 
basis to deny a special-issuance medical certificate. Current FAA 
special-issuance practice has been to consider applicants who had taken 
psychotropic medication only if they had discontinued it for at least 3 
months prior to application. Upon careful review and reconsideration, 
the FAA is modifying its long-standing, special-issuance practice. The 
FAA has determined that aviators diagnosed with depression taking one 
of four specific

[[Page 17048]]

SSRIs may be considered for special issuance of an airman medical 
certificate. Affected applicants will continue to be considered on a 
case-by-case basis and in keeping with the conditions and limitations 
announced in this policy statement.
    As reported in the Federal Air Surgeon's Medical Bulletin, Vol. 42, 
No. 3, 2004-3 (article entitled ``Depression and Use of SSRIs in 
Pilots''), since developed in the 1980s, SSRIs have been used 
successfully to treat many psychiatric disorders and medical 
conditions. Because SSRIs have been more effective and better tolerated 
(fewer side effects) than previous antidepressant medications, they 
soon became the most frequently prescribed medications for depression. 
Five of the top 40 medications prescribed in the United States are 
SSRIs and their usage is increasing.
    Some civil aviation authorities have adopted more flexible policies 
to consider some applicants using SSRIs. Similarly, the International 
Civil Aviation Organization (ICAO), the aerospace medical community, 
and the aviation community at large have made recommendations that 
suggest more flexibility may be appropriate in some cases. These 
policies and recommendations may be summarized as follows:
     Aerospace Medical Association: In 2004, published a 
position paper recommending that the FAA allow usage of SSRIs.
     Aircraft Owners and Pilots Association: In 2006, proposed 
a change to policy and offered a protocol for allowing use of certain 
SSRIs in pilots.
     Air Line Pilots Association Aeromedical Office: In 2002, 
proposed a policy for granting Special-Issuance Medical Certificates 
for selected SSRIs and with ongoing medical monitoring.
     Civil Aviation Safety Authority of Australia: In 1987, 
allowed use of certain SSRIs. A 10-year follow-up study (1993-2004) of 
481 pilots showed no increase in accidents.
     ICAO: In 2009, adopted a Recommended Practice that advises 
that signatory States may certificate applicants on a case-by-case 
basis who are prescribed (and are taking) an approved SSRI 
antidepressant medication for an established diagnosis of depression 
which is in remission.
     Transport Canada: In 2004, allowed (with no adverse affect 
on safety) six pilots holding first-class certificates and serving in 
multi-crew settings selected use of only three specific medications.
     U.S. Army: In 2005, offered a waiver for use of SSRIs in 
selected pilots.
    In keeping with these recommendations and policies, broadening the 
current special-issuance policy on the use of psychotropic medication 
to allow certain antidepressants will provide the FAA latitude, on a 
case-by-case basis, to grant special-issuance medical certificates to 
applicants determined to be fit for flight. For the FAA, concern 
regarding applicants who may be reluctant to disclose or who may be 
masking a struggle with depression remains a safety concern that this 
policy will serve to address.

Policies and Recommendations the FAA Considered

    In 2004, the Aerospace Medical Association (AsMA) [see the docketed 
copy of the article in the journal Aviation, Space, and Environmental 
Medicine entitled ``Aeromedical Regulation of Aviators Using Selective 
Serotonin Reuptake Inhibitors for Depressive Disorders'' (Vol 75, No. 
5)] proposed that aeromedical certifying authorities remove the current 
absolute prohibition against pilots flying while taking SSRIs and adopt 
aeromedical protocols that include carefully controlled followup and 
review. According to AsMA: ``Protocols designed to aggressively manage 
the full spectrum of adverse possibilities related to SSRI use may 
enable the safe use of SSRIs in formerly depressed aviators who suffer 
no aeromedically significant side effects. In these closely managed 
cases of depressive disorders, special issuances or waivers for SSRI 
use are justified.''
    In 2006, the Aircraft Owners and Pilots Association requested the 
FAA to reconsider its longstanding policy that disallows use of all 
antidepressant medication. In its request, AOPA states that the FAA 
should consider those pilots who have a ``demonstrated history of 
continued stability and show no adverse symptoms while using 
psychotropic medications, specifically SSRIs for a special issuance of 
a third-class medical certificate.''
    AOPA indicates that the Civil Aviation Safety Authority of 
Australia (CASA) has allowed medical certification of aviators using 
antidepressants since 1989. ``Although CASA's policy was not formalized 
until 2001, the compiled data of 481 cases did yield evidence 
suggesting that the use of antidepressants in carefully screened and 
well-monitored airmen can safely be undertaken without compromising 
aviation safety. A smaller study conducted by Transport Canada among 
military aviators reached a similar conclusion. The results of the 
Australian and Canadian experience and the conclusion of aviation 
medical experts clearly favor the use of SSRIs under controlled 
conditions. Because of these encouraging results, AOPA believes that 
this is an opportune time for the FAA to change its policy regarding 
the use of certain SSRIs.''
    An August 2007 research article published in the journal Aviation, 
Space, and Environmental Medicine (Vol. 78, No. 8) entitled 
``Antidepressant Use and Safety in Civil Aviation: A Case-Control Study 
of 10 Years of Australian Data'' followed the impact of SSRI usage on 
aviation safety. (A copy of this article is placed in the docket.)
    According to the article, the aim of the study was ``to identify 
significant safety-related outcomes, such as aircraft accidents or 
incidents that may be related to the use of antidepressant medication 
in pilots and air traffic controllers.'' The study employed a matched 
cohort of all holders of Australian aviation medical certificates who 
were prescribed antidepressants during the period January 1, 1993 to 
June 30, 2004, and a matched comparison group. No significant 
differences between the two groups were found in any of the analyses. 
Provided specific criteria were met and maintained, no evidence of 
adverse safety outcomes was found arising from permitting individuals 
to operate as commercial or private aircrew or air traffic controllers 
while using antidepressants.
    In November 2009, the International Civil Aviation Authority (ICAO) 
adopted a Recommended Practice that advises that signatory States may 
certificate applicants on a case-by-case basis who are prescribed (and 
are taking) an approved SSRI antidepressant medication for an 
established diagnosis of depression which is in remission. The 
recommendation reads as follows:

    6.3.2.2.1, 6.4.2.2.1, 6.5.2.2.1 Recommendation.--An applicant 
with depression, being treated with antidepressant medication, 
should be assessed as unfit unless the medical assessor, having 
access to the details of the case concerned, considers the 
applicant's condition as unlikely to interfere with the safe 
exercise of the applicant's license and rating privileges.

    In guidelines provided for assessment of applicants treated with 
antidepressant medication in its Manual of Civil Aviation Medicine (Doc 
8984), ICAO indicates: ``Some of these [antidepressant] medications are 
sedating and some are not, thus offering a therapeutic choice in 
treating depressed patients who show psychomotor agitation or 
retardation. Fewer side effects generally result in

[[Page 17049]]

improved aeromedical safety. However, successful treatment of 
depression is a dynamic and complex process involving more than just 
writing a prescription, and the SSRIs can have some aeromedically 
significant side effects and withdrawal effects that are of little 
importance in ordinary clinical practice. Aeromedical policies that 
place an absolute prohibition on operating after a diagnosis of 
depression may also make it less likely that an aviator or air traffic 
controller will seek treatment or declare their illness to the 
licensing authority.''

Forthcoming Notice Related to This Action

    FAA studies have shown that certain antidepressants (SSRIs) were 
found in 61 pilot fatalities of civil aviation accidents that occurred 
during 1990-2001. (See copies of DOT/FAA/AM-07/19 and DOT/FAA/AM-03/7 
placed in this docket.) In conducting these studies, researchers from 
the FAA Civil Aerospace Medical Institute retrieved medical information 
on 59 of the 61 pilots from the FAA Medical Certification Database and 
accident cause/factor information from the National Transportation 
Safety Board's Aviation Accident Database. (Information on two pilots 
was not available because one had no medical certificate and one held 
Canadian certification). Psychological conditions and/or the use of 
drugs were determined to be the cause or a factor in 19 (31%) of the 61 
accidents. Study findings indicated that SSRIs were used by the 
aviators but were not reported in their aeromedical examinations. The 
FAA remains concerned that individuals seen in the study did not 
disclose a medical history of depression, a related medical condition, 
or SSRI usage.
    According to a May 2004 report published in the journal Aviation, 
Space, and Environmental Medicine (Vol 75, No. 5) entitled 
``Aeromedical Regulation of Aviators Using Selective Serotonin Reuptake 
Inhibitors for Depressive Disorders,'' pilots would rather risk not 
taking prescribed antidepressant medication than be grounded. The 
report (placed in the docket) refers to information about the use of 
SSRIs available from the Aviation Medicine Advisory Service (AMAS) of 
Aurora, Colorado which provides consultation to various aviation 
organizations such as pilot unions and aerospace medicine specialists. 
This database includes information on approximately 68,000 pilots 
working at approximately 55 air carriers. According to the report:

    AMAS reviewed its database of telephone inquiries from pilots 
between 1992 and 1997. It had received 1,200 telephone inquiries 
from pilots who had been diagnosed as having clinical depressions, 
and who had been advised by their physicians to take antidepressant 
medications. Under the current FAA policy, these pilots would spend 
about 9 mo (sic) off flying status. These pilots had called AMAS to 
discuss the aeromedical implications of their situations.
    When advised of the FAA's policy, that each would be grounded 
until the depression had cleared and the medication had been 
discontinued for approximately 3 mo (sic), the pilots indicated 
their intended responses to the prospect of not flying for 9 mo 
(sic) or more. Of the 1,200 pilots, some 59% (710) told the AMAS 
that they would refuse the medication and continue to fly. About 15% 
(180) indicated an intention to take the medications and continue 
their flight duties without informing the FAA. The remaining 25% 
(300) said they would take sick leave, undergo the recommended 
treatment, and return to work when aeromedically cleared to do so.

    Scenarios involving individuals who might risk flying while taking 
an antidepressant without medical oversight, or flying without taking 
an antidepressant when they need to be, are unacceptable. Without 
condoning what we regard as a serious violation of FAA regulations and 
a serious breach of the trust on which the aeromedical certification 
system depends, we want to encourage pilots who are suffering from 
depression or who are using antidepressants to report this information 
honestly. We want individuals to be forthcoming about depression and 
antidepressant usage. We plan, therefore, to announce in a separate 
Federal Register notice a one-time, limited opportunity to reveal 
previously undisclosed depression and use of antidepressant medications 
without being subject to FAA enforcement action. Our intent is to 
enhance safety by having those individuals suffering from depression 
and using antidepressants do so with appropriate aeromedical oversight.

Policy Statement

    After careful consideration, the FAA has determined that selected 
individuals who are being treated for depression with one of four 
specific antidepressant medications may be considered for special 
issuance of a medical certificate. Individuals granted a special-
issuance medical certificate under this policy may take only one type 
of antidepressant medication limited to the following four medications: 
Fluoxetine (Prozac), Sertraline (Zoloft), Citalopram (Celexa), or 
Escitalopram (Lexapro). All these medications are SSRIs, 
antidepressants that help restore the balance of serotonin, a naturally 
occurring chemical substance found in the brain.
    The FAA is limiting consideration of special-issuance medical 
certificates to these four medications. Increasingly accepted and 
prevalently used, these four antidepressants may be used safely in 
appropriate cases with proper oversight and have fewer side effects 
than previous generations of antidepressants. While the focus of this 
policy statement is on individuals being treated for depression, the 
FAA realizes that these four medications may be used to treat 
conditions other than depression. It should be noted, therefore, that, 
in all instances, the FAA will continue to consider applicants and make 
determinations on a case-by-case basis under the special-issuance 
process just as it always has.
    In addition to treating psychiatrists, AMEs who have specialized 
training under a program called the Human Intervention and Motivation 
Study (HIMS) also will assist the FAA by making recommendations about 
certification cases to be considered under this new policy. The HIMS 
program is a safety-critical aviation program established nearly 40 
years ago. The program, developed specifically for commercial pilots, 
was designed as an alcohol and drug assistance program to coordinate 
the identification, assessment, treatment, and medical certification of 
pilots in need of help. Under HIMS, pilots who successfully meet 
rigorous FAA protocols may be returned to duty in accordance with 14 
CFR 67.401. The FAA will apply the basic HIMS evaluation and monitoring 
approach to this new policy and HIMS AMEs will participate in a 
specialized training program tailored to evaluating and monitoring 
applicants who wish to be considered under this new policy.
    No regulatory changes are being made under this policy. Further, 
the FAA continues to believe that applicants requiring use of multiple 
antidepressant medications or use of any other psychotropic medication 
in conjunction with any one of the four specified in this policy will 
not meet the criteria set forth under this policy. The use of 
psychotropic medication continues to be disqualifying under the medical 
standards and special-issuance certification will be granted only after 
thorough analysis of each individual case presented and only when 
appropriate conditions and limitations are in place so that the 
applicant may safely be permitted to operate an aircraft. It should be 
noted that as new information becomes available and recommendations 
from the medical

[[Page 17050]]

community change it may be necessary for the FAA to again revise its 
policy.
    The FAA special-issuance policy will include consideration for 
depression treated with certain antidepressant medication under the 
guidance set forth as follows:

 Consideration for Special Issuance of a Medical Certificate With Regard
                  to Depression Treated With Medication
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This protocol applies to considerations for special-issuance medical
 certification for airmen requesting first-, second-, and third-class
 special-issuance medical certificates, for the exercise of privilege
 under 14 CFR parts 121, 135, or 91, who are being treated with certain
 antidepressant medications.
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                        Criteria To Be Considered
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               Diagnoses                       Required Reports and
Mild to moderate depressive disorders,             Consultations
 such as:                                (Initial Consideration)
                                         1. A consultation status report
 1. Major Depressive Disorder (mild to    (and follow-up reports as
 moderate) either single episode or       required) from a treating
 recurrent episode                        psychiatrist attesting to and
 2. Dysthymic Disorder                    describing the applicant's
 3. Adjustment disorder with depressed    diagnosis, length and course
 mood                                     of treatment, dosage of the
Pharmacologic Agents Considered           antidepressant medication
(Single-Agent Use Only)                   taken, and presence of any
1. Fluoxetine (Prozac);                   side effects from the
2. Sertraline (Zoloft);                   antidepressant the applicant
3. Citalopram (Celexa); or                takes or has taken in the
4. Escitalopram (Lexapro)                 past;
Specifically Unacceptable Diagnoses and  2. A written statement prepared
 or Symptoms                              by the applicant describing
1. Psychosis                              his or her history of
2. Suicidal ideation                      antidepressant usage and
3. History of electro convulsive          mental health status;
 therapy (ECT)                           3. A report of the results of
4. Treatment with multiple                neurocognitive psychological
 antidepressant medications               tests with provision of the
 concurrently                             raw test data, including, but
5. History of multi-agent drug protocol   not limited to: COGSCREEN AE,
 use (prior use of other psychiatric      Trails A/B; Stroop Test; CCPT,
 drugs in conjunction with                PASSAT, Wisconsin Card Sorting
 antidepressant medications)              Test;
Psychiatric Status                       4. An evaluation and a written
1. All symptoms of the psychiatric        report from a HIMS-trained AME
 condition for which treatment is         who has reviewed items 1., 2.,
 indicated must be ameliorated by the     and 3. above and who makes a
 single medication and the condition      recommendation for a special-
 must be stable with no change in or      issuance medical certificate;
 exacerbation of symptoms for 12 months   and
 prior to certification;                 5. Any additional information
2. Airman must be on a stable dosage of   the Federal Air Surgeon may
 medication for a minimum of 12 months    require to make a
 prior to certification; and              determination.
3. Airman must have no aeromedically
 significant side effects of prescribed
 medication.
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    Issued in Washington, DC on March 26, 2010.
Frederick E. Tilton,
Federal Air Surgeon.
[FR Doc. 2010-7527 Filed 4-2-10; 8:45 am]
BILLING CODE 4910-13-P