[Federal Register Volume 75, Number 64 (Monday, April 5, 2010)]
[Rules and Regulations]
[Pages 17047-17050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-7527]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 http://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
http://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 http://DocketsInfo.dot.gov.
Docket: To read background documents or comments received, go to
http://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 [email protected].
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 (http://www.regulations.gov);
2. Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies or
3. Accessing the Government Printing Office's Web page at http://www.gpoaccess.gov/fr/index.html.
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
------------------------------------------------------------------------
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
Criteria To Be Considered
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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