Transcript: Expanded Access Part 2: How to Submit a Single Patient IND (September 2019)

In this video, we will discuss how to submit emergency and non-emergency expanded access applications. For both drugs and biologics, these applications are called either a single patient IND or an emergency IND.

In an emergency, you may make a request to treat a patient with an investigational drug before you submit a written request. An emergency request may be made by telephone, fax, or other means of electronic communication. FDA may authorize an emergency IND application over the telephone. You must report the emergency treatment to an Institutional Review Board within 5 working days and submit the written request to FDA within 15 working days of the initial authorization. An emergency IND timeline is available on the FDA website to guide you through the process.

In a non-emergency situation, you must submit a written request to FDA before shipment of, or treatment with, the drug. Treatment may proceed 30 days after FDA receives your application or upon notification from FDA that expanded access use may begin, whichever comes first. FDA has 30 calendar days to review the request, but in most cases, we complete the review within a few days.

If the expanded access request is allowed to proceed, we will notify you either by phone or email and follow-up with a formal letter. The letter acknowledging receipt of your IND will include your IND number, which may be requested by the company in order to ship the drug.

While office staff and other healthcare professionals can help with the administrative elements of preparing the request to be submitted to the FDA, you, the physician, must ultimately sign and be responsible for the request.

Follow these four steps to apply.

Step 1. Request a Letter of Authorization

The first step in any expanded access request is to ask the pharmaceutical company if they are willing to provide the investigational drug. If the company agrees, ask them to provide you a Letter of Authorization that grants you the right to reference the information contained in the company’s existing IND.

If it is not possible to obtain a Letter of Authorization, contact the applicable FDA Center and Review Division to determine what other sources of information may satisfy submission requirements for your IND.

A Letter of Authorization template is available on the FDA website.

Step 2. Submit Form FDA 3926

Form FDA 3926 was specifically designed for single patient expanded access requests submitted by physicians and is the easiest way to apply. If you are familiar with Form FDA 1571, you may still use that form. However, we encourage use of the much simpler Form FDA 3926.

For step-by-step instructions on completing Form FDA 3926, watch Part 3 of this video Series.

Step 3. Obtain approval from the Institutional Review Board

For a non-emergency IND, you must obtain approval from an Institutional Review Board prior to treating a patient under expanded access. This is an important step to protect the rights and safety of patients. However, we recognize that assembling the full board may cause delays if the board does not routinely meet.

On Form FDA 3926, you can indicate that you will obtain concurrence from the IRB chairperson or from a designated IRB member in lieu of full IRB review. Alternatively, when using Form FDA 1571, a separate waiver request is needed along with the application if you wish to obtain concurrence from the IRB chair or designee instead of the full IRB review. IRB requirements for emergency treatment are discussed earlier in this video.

Step 4. Obtain informed consent

Obtain informed consent from the patient or their legally authorized representative.

Upon receipt of the expanded access request, FDA will either allow the treatment to proceed or place the application on clinical hold. Clinical holds are rarely necessary. If needed, we may contact you for more information to process your request.

For assistance, contact FDA’s Division of Drug Information. If you’re already working with the Review Division, give them a call.

Related Information

• Expanded Access Part 2: How to Submit a Single Patient IND (September 2019)
• FDA Drug Info Rounds Video