Emergency Use INDs

Emergency Use IND allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21CFR, Sec. 312.23 or Sec. 312.34. It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist. 

Frequently, circumstances arise during the interval between NDA submission and approval which make it desirable for the (still) investigational drug to be made more widely available. The Treatment IND or the Emergency Use IND (21CFR para 312.36, see above) generally accommodates this need (21CFR paras 312.34 and 312.35). 

Emergency Use IND applications are usually granted for those situations where time does not allow for submission of the IND through the normal channels. Patients usually do not meet the criteria of an existing protocol. 

Three t)rpes of rmusual IND situations deserve special mention. First, the regulations contain a provision governing emergency use of an investigational new drug. Where FDA will permit such use by telephone or other rapid communication means. In these situations, the IND must subsequently be amended to reflect the new situation. Second, FDA will approve specific... 

When a human subject does not meet the criteria stipulated in an existing study protocol or if an approved study protocol is not available, the manufacturer of the test article should be contacted to determine if the company will make the test article available for emergency use under the manufacturer s IND. If an emergency occurs before an IND submission and the manufacturer agrees to make the test article available, the FDA would have to authorize shipment. 

Emergency and Compassionate-use INDs and Accelerated NDA or ANDA Approvals—Procedures, Benefits and Pitfalls... 

It should be noted that off-label use of approved products (i.e. prescribing lawfully marketed products for indications other than those stated in their labeling) does not require an Emergency IND, under 21 CFR paras 312.2(b)(i)-(v), provided that the intended use... 

Finally, it is apparent that requirements of federal regulatory agencies (OSHA, FDA) not primarily concerned with emergency response to low-frequency events like chemical or biological terrorism nevertheless have a substantial influence on response capabilities. The characteristics and rules for use of personal protective equipment, for example, fall under the jurisdiction of the Occupational Safety and Health Administration. The investigational (IND) status of some very specific treatments, present and future, will hamper their use in mass-casualty situations. Furthermore, in the case of many treatments, collection of the data on efficacy necessary for full FDA approval will not be possible for ethical reasons or economically attractive to a potential manufacturer because of limited market potential. 

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