FDA regulations at 21 CFR 56.102(d), 21 CFR.104(c), 21 CFR 312.36 and this policy pertain to the “emergency use”, without prospective IRB review and approval of an unapproved drug or biological product in a patient with a life-threatening (or severely debilitating) problem under the following conditions:
- the condition is life threatening necessitating use of the test article
- no standard acceptable treatment is available
- there is not sufficient time to obtain prospective IRB approval.
Note - If IRB review is possible, prospective IRB approval should be sought. Only if treatment of a life-threatening condition is necessary before IRB approval is made, does this “emergency use” policy apply.
For purposes of this policy, “life threatening” means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted; or diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life threatening do not require the condition to be immediately life threatening or to immediately result in death. Rather, the subjects must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible. Per the FDA also, “severely debilitating” means diseases or conditions that cause major irreversible morbidity such as blindness, loss of hearing, paralysis or stroke.
Federal regulations stipulate that research activities may not be started, even in emergency situations, without prior IRB review and approval. Whenever “emergency use” of an investigational product is initiated without prior IRB approval, the patient may not be considered a research subject, the emergency treatment may not be claimed as research, and data obtained from this treatment may not be included in any report of a research activity or used for research purposes.
Federal regulations, guidance documents and this policy are not intended to limit the authority of a physician to provide emergency medical care to the extent permitted under applicable federal, state or local law [c.f. 45 CFR 46.116(f)]. Rather, this policy pertains only to the use of an investigational (i.e. “test”) article [21 CFR 56.102(l)]in emergency situations.
The emergency use of an unapproved investigational drug or biologic requires an IND unless the intended subject meets the inclusion criteria of an existing study protocol, or an approved study protocol exists. The IND requirement may be met if the manufacturer makes the drug or biologic available for the emergency use under the manufacturer’s IND.
If the emergency situation does not allow time for submission of an IND or amendment of the manufacturer’s IND, only the FDA may authorize shipment of the test article in advance of the IND submission (or amendment). Requests for such authorization may be made by telephone or other rapid communication means to the FDA [21 CFR 312.36].
Note – FDA Contacts for Obtaining an Emergency IND:
||Office/Division to Contact
|Division of Drug Information
Biological Blood Products
|Office of Blood Research and Review
Biological Vaccine Products
|Office of Vaccines Research
On Nights and Weekends
|Office of Crisis Management & Emergency