Expanded Access: Emergency Use

The emergency use of an unapproved drug or biologic provision can be used when the following conditions apply:

You wish to use the unapproved drug or biologic on a single patient;
The patient has an immediately life-threatening disease or condition for which there is no comparable alternative;
The patient is unable to qualify for a clinical trial using the unapproved drug or biologic;
The potential benefits justify the potential risks of the treatment; and,
Providing the unapproved drug or biologic will not interfere with the initiaion, conduct, or completion of clinial investigations of the drug or biologic.

The FDA must provide authorization for the use of the unapproved drug or biologic either to the Physician or the Sponsor, depending who holds the IND, prior to use.

Physician Responsibilities for Emergency Use of a Drug or Biologic

1.	The Physician must request approval from the Manufacturer/Sponsor of the drug or biologics for emergency use under the company's IND. If the Manufacturer/Sponsor does not have an IND, the Physician should obtain a Letter of Authorization (LOA) from Medical Developer/Sponsor for use of the drug or biologic. If a LOA is not available or the Manufacturer/Sponsor decluses permission to use the dru or biologic, sufficient information must be submitted in Form 3926 to assure the FDA of the product's quality.
2.	The Physician should notify the IRB of emergeny use prior to treatment, except when there is insufficient time, by submitting the Pre-Treatment section of the Expanded Access to a Test Article (EATA) application in Kuali. The Physician should consult the Emergency Use Worksheet to evalute compliance with the FDA requirements.
3.	Whoever holds the IND, whether that be the Manufacturer/Sponsor or the Physician, must request FDA Emegrency Use Authorization from the appropriate FDA review division or organization by telephone or other rapid form of communication. Authorization may be given over the phone. IND for an Investigational Drug: (855) 543-3784 or (301) 796-3400 or druginfo@fda.hhs.gov IND for an Investigational Biologic: (880) 835-4709 or (240) 402-8020 or industry.biologics@fda.hhs.gov On Nights & Weekends: (866) 300-4374 or (301) 796-8240
4.	Physician must obtain informed consent from the individual receiving the drug. The Emergency Use of a Test Article Consent Form should be used. If consent cannot be obtained, the Treating Physician and an Independent Physician must certify in writing that (1) this is a life-threatening situation necessitating use of the unapproved drug or biologic, and (2) there is no alternative treatment available.
5.	Once FDA Authorization is received, Physician can proceed with treatment.
6.	Within 5 business days of emergency use, the Physician should follow-up with or notify the IRB by submitting the Post-Treatment section of the EATA application in Kuali (or the entire application if there was insufficient time for Step 2).
7.	Also within 5 business days, the Physician should notify the Manuacturer/Sponsor of emergency use.
8.	If the Physician holds the IND, within 15 business days of emergency use, the Physician must submit Form 3926 and the LOA from the Manufacturer/Sponsor to the FDA via mail.
9.	If the Physician holds the IND, the Physician is responsible for submitting any follow-up reports to the FDA using Form 3926 as applicable.

The emergency use of an unapproved medical device provision can be used when the following conditions apply:

You wish to use the unapproved device on a single patient;
An IDE for the device does not exist, the device is being used in an un-approved way under the IDE, or the Physician is not covered by the IDE;
The patient has a serious or immediately life-threatening disease or condition for which there is no comparable alternative;
The Physician has substantial reason to believe that benefits exist; and,
Because of the immediate need to use the device, there is no time to obtain FDA approval.

Physician Responsibilities for Emergency Use of a Medical Device

1.	The Physician should obtain a Letter of Authorization (LOA) from Medical Developer/Sponsor for use of the device if an IDE exists.
2.	The Physician should notify the IRB of emergeny use prior to treatment, except when there is insufficient time, by submitting the Pre-Treatment section of the Expanded Access to a Test Article (EATA) application in Kuali. The Physician should consult the Emergency Use Worksheet to evalute compliance with the FDA requirements.
3.	The Treating Physician should request an assessment by an Independent Physician not participating in the treatment. If there is insufficient time for an independent assessment, the Treating Physician complete their own assessment; that assessment should be reviewed in writing by an Independent Physician within 5 business days after emergency use.
4.	Physician must obtain informed consent from the individual receiving the device. The Emergency Use of a Test Article Consent Form should be used. If consent cannot be obtained, the Treating Physician and an Independent Physician must certify in writing that (1) this is a life-threatening situation necessitating use of the unapproved drug or biologic, and (2) there is no alternative treatment available.
5.	Physician can proceed with Treatment.
6.	Within 5 business days of emergency use, the Physician should follow-up with or notify the IRB by submitting the Post-Treatment section of the EATA application in Kuali (or the entire application if there was insufficient time for Step 2).
7.	If an IDE exists, the Physician must notify the sponsor after emergency use.
8.	If an IDE does not exist, the Physician is responsible for notifying the FDA of emergency use. The Physican should provide the FDA with a written summary of the emergency use, all patient protection measures taken, and any scientific results.