Access to Investigational Drugs, Devices and Biologics for Clinical Use 

FDA regulations require prior approval from FDA and an IRB for research use of an unapproved investigational drug, biologic, or device. Those regulations also recognize that, in a life threatening situation where standard treatment is unavailable and treatment with an investigational product or procedure is thought to be in the best interest of the patient.

Below you will find:

  • Description of the circumstances when emergency use is appropriate
  • Process and procedures that must be followed before or immediately following an emergency use of an investigational product
IRB Contacts
414-465-3134 or 414-465-3059
IRB@ascension.org
IRB Staff


IRB FORM: Emergency Use of Investigational Drug, Device, or Biologic

IRB TEMPLATE: Emergency Use Consent template

IRB SOP: Treatment use of Investigational Drug, Biologic or Device, including Emergency Use

FDA Links
Drugs & Biologics: Physician Request for Individual Patient IND
Devices: Physician Request for Individual Patient use of an Unapproved Medical Device
  • When is Emergency Use Permitted

    Emergency use of an unapproved or investigational drug, device or biologic may occur only in those circumstances where it is not feasible to secure prospective FDA and IRB approval.

    Unless you complete the Emergency Use Process, you may not use an unapproved or investigational drug, device or biologic without prior IRB, sponsor and FDA approval.

    Emergency use is permitted only if all of the following criteria are met:

    • The patient faces a life-threatening condition (e.g., a serious disease or condition such as a sight-threatening or limb-threatening condition, as well as other situations involving risk of irreversible morbidity) that requires immediate treatment.
    • The patient is likely to benefit from treatment with the unapproved drug, biological, or device.
    • No generally acceptable alternative for treating the patient is available.
    • There is no time to use existing procedures to secure prospective FDA and IRB approval and/or informed consent.
    • The drug, device or biologic has not previously been used in the past for emergency use for another patient at the site
  • Reporting to the IRB

    Call and email the IRB Office as soon as the decision to use an unapproved or investigational drug, device or biologic is made. This should be done prior to the treatment or procedure if at all possible.

    IRB Office Phone: 414-465-3134 or 414-465-3059

    IRB Office Email: IRB@Ascension.org and/or current staff

    If the use happens after office hours, the voicemail at the numbers above will direct you where to call.

     

    The treating physicians must file a formal report of the emergency use with the IRB within within 5 calendar days of the use. An additional  follow up report is required to provide the IRB an update on the patient's outcome post-treatment.

    The initial and follow up reports to the IRB can be made using: IRB Form: Emergency Use of Investigational Drug, Device, or Biologic

  • Reporting to the FDA

    Even in an emergency where it is impossible to secure an IND or IDE in advance, FDA must be consulted prior to use.

    Contact information (24/7) for drugs/biologics and for devices is available on FDA’s website.

  • Other Procedures Required for Emergency Use

    1) After confirming that emergency use criteria is met for a drug or biologic, the treating physician must notify the local pharmacy and Manufacturer to coordinate shipment of the drug.

    2) If time permits prior to treatment with an investigational agent, the treating physician should secure the following:

    • An independent assessment by a physician uninvolved with the investigation, as required in 21 CFR 50.23. The assessment must certify the physician’s agreement that all of the criteria have been met:
      • The subject was confronted by a life-threatening situation (including one involving risk of serious, irreversible morbidity), necessitating use of the product.
      • At the time of the procedure, there was no available alternative method of approved or generally recognized therapy that would have provided equal or greater likelihood of saving the subject’s life or avoiding serious, irreversible morbidity.
    • Informed consent OR certification from an Independant Physciain
    • An outside physician’s certification that:
    • Concurrence from the RI&P/IRB office that there is an emergency or, preferably, prospective IRB approval (in which case the use is not an emergency use) exists.
    • Permission from the IND or IDE holder of the drug, device or biologic (i.e., the sponsor of a trial/drug or device manufacturer).
  • Physician Responsibilities After Emergency Use

    Promptly following an emergency use (within 5 calendar days):

    • Obtain an independent physician assessment if time did not permit prior to the treatment or procedure.
    • Write or dictate a note or report including a statement of who administered the drug or placed the device and why it was used.
    • Submit a report to the IRB (See Reporting to the IRB section above).
    • Submit a report to the sponsor (IND/IDE holder).
    • If you are the sponsor, notify the FDA of the emergency use and provide FDA with a written summary of the conditions constituting the emergency, subject protection measures, and results.
    • Evaluate the likelihood of a similar need for the drug/device occurring again. Refrain from further emergency use until any necessary approvals have been secured (e.g., opening of a new “high risk” arm on the trial), even if the conditions for an emergency use otherwise exist.
    • Other than mandatory reports to FDA or the sponsor, do not use data related to the emergency use in any publication or report on a related research project.