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Emergency Use of an Unapproved Drug, Biologic or Device

Overview

List of Previous Emergency Uses of Test Articles at UCI

  • BAT AB
  • Clofazimine
  • Diethylcarbamazine
  • Epicel
  • IB Ribavirin
  • Varizig
  • Yondelis

Emergency Use is defined as the one-time (per institution) use of a test article (an investigational drug, biological product, or medical device) for a patient in a life-threatening situation where no standard acceptable treatment is available and there is not sufficient time to obtain IRB approval [21 CFR 56.102(d)].

Emergency Use does not require prior IRB review and approval, but must meet federal regulatory criteria. At UCI, we recommend that the investigator notify the IRB prior to the emergency use of a test article. The IRB will work with investigators to make sure patients are treated as soon as possible and in accordance with federal regulations. The investigator is required to submit the Emergency Use of a Test Article form to the IRB within 5 business days after the emergency use [21 CFR 56.104 (c)].

Procedure for Seeking Emergency Use of a Test Article from a Manufacturer

An investigator who wants approval of an emergency use of a test article should first check the List of test articles previously used at UCI in an Emergency Use situation. If the drug or biological product is not listed, contact the manufacturer to determine if the product can be made available (for one, specific patient) under the company’s IND; or if the company declines or cannot be reached, the investigator can contact the FDA for an emergency IND. For medical devices, contact the manufacturer to determine if the product can be made available. Also ensure that the FDA will be notified immediately after the unapproved device is shipped for an emergency use. An unapproved device may not be shipped in anticipation of an emergency. If the company declines or cannot be reached, the investigator can contact the FDA.

The FDA allows one-time (per institution) emergency use of a test article. If the test article is listed on the Emergency Use list web page, please submit an IRB application for review and approval.

Instructions for Requesting Permission for Emergency Use of a Test Article from the IRB

Informed Consent for Emergency Use

If permission for emergency use is granted prior to treating the patient with the test article, the investigator should obtain the informed consent of the patient or his/her legally authorized representative (LAR). A witness should also be present during the informed consent process and should sign the consent form along with the investigator. An emergency use consent form template is available for tailoring for the specific emergency use situation. Note: No other emergency use consent form should be signed by the patient or the LAR (e.g., drug manufacturer consent for emergency use).

If the patient is unable to provide consent and a LAR is not available, but a life-threatening situation necessitating the immediate use of the test article is present, an exception for the informed consent requirement may apply. In this situation, both the investigator and a physician who is not otherwise participating in the emergency use situation must certify in writing on the "Emergency Use of a Test Article" form that following criteria are met:

The IRB recommends that you prospectively obtain the IRB Chair's determination that the situation meets the above criteria for the exception from the requirement to obtain informed consent; otherwise the assessment will be conducted retrospectively.

Reporting Requirements Following Emergency Use of a Test Article

Per FDA regulations the investigator is required to submit a written follow-up report to the IRB within five (5) working days of the emergency use of an investigational drug, agent, biologic, or device.

The paperwork and report filing required by sponsors, drug companies, and the FDA are the responsibility of the UCI investigator requesting the emergency waiver of approval.

Additional Reporting Requirements

Adverse events and unanticipated problems that result from the emergency use of a test article are subject to UCI IRB AE/Unanticipated Problems reporting requirements.

Disposition of Data Obtained Under Emergency Use Provision

The Office of Research Administration obtained the following guidance from the Food and Drug Administration's Center for Drug Evaluation and Research and the Office for Human Research Protections (OHRP), two federal agencies that regulate the conduct of human subjects research.

The FDA requires data from all investigational uses, including the Emergency Use provision, to be retained and, in the case of commercially sponsored research, submitted to the sponsor when requested.

The FDA considers that when an investigator conducts an emergency use of a test article in a life-threatening situation without prior IRB review, the activity is research and the patient is a subject. As such, FDA may require data from an emergency use of a test article in a life-threatening situation to be reported in a marketing application.

Therefore, reports by the sponsor/manufacturer to the FDA may include Emergency Use data, but such data may not be compiled with research data for publications or other reports, except possibly for single case reports.