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VIII.03
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Emergency Use of an
Investigational Drug, Biologic, or Unapproved Medical Device
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Objective
This procedure describes the process of acknowledgement of receipt of
notification by a physician of the intended use of an investigational drug or unapproved
device in an emergency situation. The procedure also describes the physician’s
follow-up after the treatment.
Policy/Procedure
I.
If a situation arises necessitating the use of an investigational drug,
agent or biologic, in an emergency situation (“Event”) the treating physician
must:
A. if the intended subject
does not meet the criteria of an existing study protocol, or if an approved
study protocol does not exist, contact
the manufacturer of the investigational drug, agent, or biologic to determine
if the test article can be made available for the emergency use under the
manufacturer’s IND; or
B. if, due to the emergency
situation, there is not time for submission of the IND,
the treating physician may make a direct request to the FDA to authorize shipment
of the test article in advance of the IND
submission.
C. Contact the CPHS Chairman
of the Executive Committee (Executive Chairman), or designee, who must be an
MD, and notify him/her of the Event and the following:
1. An explanation of the conditions supporting the
determination that the patient is in an immediate serious or life-threatening
condition that needs immediate treatment;
2. There is no generally acceptable alternative
treatment; and
3. An informed consent document for review. The physician
is required to obtain informed consent of the patient or the patient’s legally
authorized representative. The Executive Chairman will determine that the
physician will be obtaining informed consent or, if the subject or the legally
authorized representative cannot give consent, the Executive Chairman will
review the situation to evaluate whether it meets the FDA regulatory
requirements for waiver of informed consent with emergency use of a drug or
biologic. If the latter is the case, the treating physician and a physician who
is not otherwise participating in the treatment of the subject shall certify in
writing the following:
a)
The patient is confronted by a life-threatening and/
or severely debilitating situation necessitating the use of the investigational
drug, agent, or biologic;
b)
Informed consent cannot be obtained because of an
inability to communicate with, or obtain legally effective consent from, the
patient;
c)
Time is not sufficient to obtain consent from the
patient’s legal representative; and
d)
No alternative method of approved or generally
recognized therapy is available that provides an equal or greater likelihood of
saving the patient’s life.
4. If, in the treating physician’s opinion, immediate
use of the test article is required to preserve the patient’s life, and if time
is not sufficient to obtain an independent physician’s determination that the
four conditions listed above apply, the treating physician should make the
determination and, within five working days after the use, have the determination
reviewed and evaluated in writing by a physician who is not participating in
the Event.
5. The Executive Chairman will review the use to
evaluate whether the situation meets the FDA regulatory requirements that allow
exemption from CPHS review of the Event. The following may be requested to
facilitate the evaluation:
a)
An authorization from the sponsor or manufacturer to
allow the use by the treating physician for the test article;
b)
An approved IND
or a letter explaining exemption from the FDA;
c)
An adequate description of the situation regarding
the use of the test article with an independent physician’s certification, if
applicable; and
d)
Any other information that may aid in the
evaluation.
6. The Executive Chairman will notify the Manager of
the Office of Research Support Committees of the use within 24 hours of
receiving the request and granting permission.
D. After emergency use
/treatment of investigational drugs, agents, or biologics
1. The treating physician is required to submit a
written follow-up report to the CPHS within five (5) working days of the
emergency use of an investigational drug, agent or biologic. This report should
include:
a)
Name of the investigational drug, agent, or
biologic;
b)
Conditions under which the investigational drug,
agent, or biologic was administered;
c)
Date and time administered;
d)
Any adverse events or unanticipated problems to
recipient or others; and
e)
Outcomes, if known.
2. Any subsequent use of the test article is subject to
CPHS review. FDA acknowledges, however, that it would be inappropriate to deny
emergency treatment to a second individual if the only obstacle is that the
CPHS has not had sufficient time to convene a meeting to review the issue.
3. The treating physician is to evaluate the likelihood
of a similar need for the drug, agent, or biologic and if future use is likely,
immediately initiate efforts to obtain CPHS approval and an FDA approved IND
for the drug, agent or biologic’s subsequent use.
II. The FDA recognizes that emergencies
arise where an unapproved medical device may offer the only possible
life-saving alternative, but an IDE for the device does not exist, or the
proposed use is not approved under an existing IDE, or the physician or
institution is not approved under the IDE. Using its enforcement discretion,
FDA may choose to approve the use of an unapproved medical device in such an
emergency, provided the treating physician justifies to the FDA that an
emergency actually existed.
A. To be considered an
emergency each of the following must exist:
1. The patient is in a life-threatening condition that
needs immediate treatment; and
2. No generally acceptable alternative for treating the
patient is available; and
3. Because of the immediate need to use the device,
there is no time to use existing procedures to get FDA approval for the use.
B. The FDA expects the
treating physician to determine the following:
1. Whether the criteria for emergency use have been
met;
2. Potential benefits from the unapproved use of the
device with substantial reason to believe that benefits will exist;
3. Assurance the decision that an “emergency” exists is
not based solely on the expectation that IDE approval procedures may require
more time than is available.
C. The treating physician is
expected to follow as many subject protection procedures as possible. These
include:
1. Obtaining an independent assessment by an uninvolved
physician;
2. Obtaining informed consent from the patient or a
legal representative;
3. Notifying institutional officials as specified by institutional
policies; and
4. Notifying the CPHS; and
5. Obtaining authorization from the IDE holder, if an
approved IDE for the device exists.
D.
The treating physician shall contact the CPHS Executive Chairman, or
designee, (must be an MD), and notify
him/her of the Event and include in writing the items in I.C above.
E.
The investigator is required to obtain informed consent of the subject or
the subject's legally authorized representative unless both the investigator and
a physician who is not otherwise participating in the Event certify in writing
all of the following:
1. The subject is confronted by a life-threatening
situation necessitating the use of the unapproved medical device
2. Informed consent cannot be obtained because of an
inability to communicate with, or obtain legally effective consent from, the
patient
3. Time is not sufficient to obtain consent from the
patient's legal representative.
4. No alternative method of approved or generally
recognized therapy is available that provides an equal or greater likelihood of
saving the patient's life.
F.
If, in the treating physician’s opinion, immediate use of the test
article is required to preserve the patient's life, and if time is not
sufficient to obtain an independent physician's determination that the four
conditions above apply, the treating physician should make the determination
and, within 5 working days after the use of the unapproved medical device, have
the determination reviewed and evaluated in writing by a physician who is not
participating in the treatment.
G. The treating physician is
required to submit a written follow-up report to the Executive Chairman, or
his/her designee within five (5) working days of the emergency use of an
unapproved device. This report should include:
1. Name of the unapproved device;
2. Conditions under which the unapproved device was
administered;
3. Date and time administered;
4. Name, IDE number and source of the device;
5. Any adverse events or unanticipated problems to
recipient or others; and
6. Outcomes, if known.
H. If an IDE for the use does
exist, the treating physician is to notify the sponsor of the emergency use, of
if an IDE does not exist, he/she is to notify the FDA of the emergency use and
provide the FDA with a written summary of conditions constituting the
emergency, patient protection measures, and results.
I.
The treating physician is to evaluate the likelihood of a similar need
for the unapproved device and if future use is likely, immediately initiate
efforts to obtain CPHS approval and an FDA approved IDE for the unapproved
device’s subsequent use.