Physician Request for a Single Patient IND for Compassionate or Emergency Use
When a physician would like to request an Investigational New Drug (IND) application to
use an unapproved drug or other product for a single patient, the first step is to obtain permission
from the manufacturer. Without the consent of the manufacturer, the unapproved product will not be
available to the patient. After the manufacturer agrees to provide the product, the recommended procedure is
to submit the following information to the appropriate review division. The request may be
made by fascimile with a letter to follow.
- Request for a single patient IND for Compassionate or
Emergency Use should be stated at the top of the correspondence.
- Brief Clinical History of the patient including the diagnosis, the
disease status, prior therapy, response to prior therapy and the rationale for requesting
the proposed treatment.
- Proposed Treatment Plan including the dose, route, planned
duration, monitoring procedures and modifications (e.g. dose reduction or treatment delay)
for toxicity. Reference a published protocol or journal article if appropriate.
- Drug Supply Reference Statement which would name the supplier or
manufacturer and a statement that a Letter of Authorization to cross reference an
appropriate IND of the supplier or Drug Master File (DMF) of the manufacturer is included.
The treating physician must contact the supplier or manufacturer for such a statement.
- Informed Consent Statement that states that informed consent and
approval of an appropriate Institutional Review Board (IRB) will be obtained prior to
initiating treatment. There are some IRBs that have specific procedures for approving
emergency requests.
- Investigator Qualification Statement that specifies the training,
experience, and licensure of the treating physician. The first two pages of a Curriculum
Vitae typically contain this information and are usually sufficient.
- FDA Form 1571 completed with the treating physician listed as the
sponsor. Form 1571 and other forms
can be downloaded from the Internet.
- Contact telephone number and facsimile number. If the request is
approved, an IND number will be issued by the FDA and the treating physician will be
contacted by phone or fax with a letter to follow. The IND is considered active upon
issuance of the number. The IND sponsor (treating physician) will then contact the drug
supplier and provide the IND number. The supplier may then ship the drug directly to the
treating physician.
For further information, please contact the appropriate Review Division.
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