DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
|
DISTRICT OFFICE ADDRESS AND PHONE NUMBER
900 Madison Avenue
Baltimore, MD 21201
410-962-3396 |
DATE(S) OF INSPECTION
6/18,19,20,21,28/01
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FEI NUMBER
3003350724
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NAME
AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED
TO: Alkis
Togias, MD, Associate Professor of Medicine |
FIRM NAME
Johns Hopkins Asthma & Allergy Clinic
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STREET
ADDRESS
5501 Hopkins Bayview Circle
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CITY,
STATE AND ZIP CODE
Baltimore, MD 21224
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TYPE
OF ESTABLISHMENT INSPECTED
Clinical Investigator
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DURING AN INSPECTION OF YOUR FIRM, I OBSERVED:
The following observations
are related to RPM No.: AACOO-07-26-02, entitled, "Mechanisms of Deep Inspiration-Induced
Airway Relaxation."
- This sponsor/clinical investigator failed to submit an IND
to the FDA prior to conducting this clinical investigation, which involved
the administration of hexamethonium bromide by inhalation to 3 human
subjects.
- The sponsor/clinical investigator failed to report an unanticipated
adverse event to the IRB.
The first subject in the study, , was administered
hexamethonium on 4/23/01. She developed a persistent cough from 4/25/01
till 5/3/01. The IRB was not notified of this event.
- Failure to follow the protocol in that the protocol stated that hexamethonium
would be administered by inhalation, when in fact; hexamethonium and
sodium bicarbonate were actually administered to the second and third
subjects.
- This sponsor/clinical investigator made changes
to the approved protocol, dated 9/18/00, without notifying the IRB and
without IRB approval, for example:
a.The sponsor/clinical investigator added sodium
bicarbonate to the hexamethonium to change its pH, for the second
and third subjects, without notifying and obtaining approval from
the IRB. There were no records available for review to determine
how much sodium bicarbonate was added.
b. The protocol approved by the IRB, dated 9/18/00,
stated that the "subjects will be premedicated with either
hexamethonium, or its vehicle (normal saline), by inhalation."
The clinical investigator administered 4.5% hyperosmolar saline
instead of the normal saline.
- Failure to obtain
effective informed consents from subjects, in that the sponsor/clinical
investigator failed to disclose that inhalation administration of hexamethonium
was an experimental use of the drug.
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SEE
REVERSE OF THIS PAGE |
EMPLOYEE(S)
SIGNATURE |
EMPLOYEE(S)
NAME AND TITLE (Print or Type)
J. Diann Shaffer, Investigator |
DATE ISSUED
6/28/01 |