FDA Expanded Access (Compassionate Use), Explained

A plain-language guide to the FDA expanded access program — what it is, who may be eligible, how the process works, and how it compares with Right to Try.

FDA expanded access — often called compassionate use — is a U.S. Food and Drug Administration pathway that can allow a patient with a serious or immediately life-threatening condition to receive a medical product that is not yet FDA-approved, outside of a clinical trial, when no comparable or satisfactory alternative therapy is available.

This guide explains how the pathway works in plain language: who qualifies, who has to say yes, what it costs, how long it takes, and what to ask your doctor. It is published free by Right2Hope, a 501(c)(3) nonprofit.

What is FDA expanded access?

New medical products are normally only available through research until the FDA approves them, and many patients are not able to take part in that research. Expanded access exists for exactly this gap: it allows a doctor to request an unapproved treatment for a specific patient (or group of patients) as treatment, not research.

You’ll see several names for the same idea: compassionate use, early access, pre-approval access, named patient programs, and managed access programs. In the United States, the formal FDA term is expanded access. For drugs and biologics, the FDA’s expanded access rules are set out in 21 CFR Part 312, Subpart I.

Every request involves your licensed physician, who makes the request; the manufacturer, which must agree to provide the product; and the FDA, which reviews the request. An Institutional Review Board (IRB) is generally involved as well.

Types of expanded access

Single patient — a request for one individual patient, including emergency requests. Physicians can use Form FDA 3926 for these requests.
Intermediate-size population — access for a group of patients with similar needs.
Widespread treatment use — access for a larger population, through a treatment IND or treatment protocol.

One honest caveat before anything else: unapproved treatments are not proven. They may not help, and they can cause serious side effects. Expanded access is about making an informed choice with your doctor when the proven options have run out — not a guarantee of benefit.

Who may be eligible for expanded access?

Under FDA rules, expanded access may be an option when all of the following are true:

You have a serious or immediately life-threatening disease or condition.
There is no comparable or satisfactory approved therapy available — standard options have been exhausted or ruled out.
You are not able to receive the treatment through a research study.
Your doctor judges that the potential benefit justifies the risks for your situation.

Meeting these general criteria does not guarantee access: the manufacturer must agree to provide the product, and the FDA reviews each request. Your doctor is the right person to judge whether expanded access fits your situation.

How the expanded access process works

The most important thing to understand: your doctor applies, not you. Your role is to start the conversation. The typical path for an individual patient looks like this:

Talk with your doctorDiscuss whether expanded access makes sense for your situation. A licensed physician must agree it is appropriate and be willing to make the request and oversee your care.
Your doctor contacts the manufacturerYour physician asks the company that makes the product whether it is willing to provide it for you.
The manufacturer agrees to provide the productNothing moves forward without the company’s agreement. Companies are not required to say yes — supply and fairness policies all factor in.
Your doctor submits the request to the FDAFor a single patient, physicians can use Form FDA 3926. In an emergency, the FDA can authorize a request by phone or email, with the written request following afterward.
IRB review and informed consentAn Institutional Review Board (IRB) — an independent ethics committee — generally reviews the plan, and you sign an informed consent form before treatment begins.
Treatment under your physician’s careOnce the request is authorized, your doctor provides the treatment, monitors how you respond, and handles any required safety reporting.

Who has to say yes — and who usually does

Three parties approve an expanded access request: the manufacturer, the FDA, and an IRB. Here is the part most guides get backwards: the FDA is rarely the obstacle.

99%

of the expanded access requests the FDA receives are authorized. In practice, the decision that matters most is the manufacturer’s — the company must agree to supply its unapproved treatment, and it is under no legal obligation to do so.

If you’re told “no,” it’s worth knowing which door actually closed, because a different path may still be open. Practical takeaway: ask your doctor about every option — different companies have different expanded access policies.

How long does expanded access take?

In an emergency, the FDA can authorize treatment over the phone and treatment may begin immediately, with the paperwork following. For non-emergency individual requests, FDA review typically takes days to weeks. The longer, less predictable part is usually before the FDA is even involved — getting the manufacturer’s agreement can take anywhere from days to months, which is another reason to start conversations early and in parallel.

For a deeper look at real-world timing, read how long FDA approval really takes.

What does expanded access cost?

Often less than patients fear, but rarely nothing. FDA rules prohibit companies from profiting on expanded access — they may only charge their direct costs of providing the drug, and many provide it free. Insurance, however, usually does not cover unapproved products, and the surrounding care — infusions, imaging, monitoring visits — may be billed normally.

Ask whether the manufacturer provides the product itself free of charge.
Ask your care team what related care will be billed, and to whom.
Everything Right2Hope does — education and guidance — is free for patients, always.

Expanded access vs. Right to Try

The federal Right to Try Act (2018) created a second, narrower pathway — we cover it in full in our patient guide to Right to Try. The biggest practical similarity is also the biggest limit of both: the manufacturer must agree to supply the treatment either way.

The key difference is oversight. Under expanded access, the FDA reviews each request and an IRB is generally involved. The federal Right to Try Act, signed into law in 2018, created a separate pathway that does not require FDA review of the individual request.

Comparison of expanded access and Right to Try pathways
	Expanded access	Right to Try
Who is eligible	Serious or life-threatening condition	Life-threatening condition only
FDA involved?	Yes — reviews and authorizes (≈99% authorized)	No FDA review of the individual request
Ethics (IRB) review	Generally required	Not required
Eligible treatments	An unapproved drug, biologic, or device	Drugs that completed Phase 1 and remain in active development
Company must agree	Yes	Yes
Safety oversight	FDA + IRB + your doctor	Your doctor

What to ask your doctor

Bring these six questions to your appointment — they cover the decisions that actually determine whether expanded access moves forward:

Have I truly exhausted the approved treatment options for my condition?
Are there other options we should consider first?
Would you be willing to oversee an expanded access request for me?
What do you know about this specific treatment, and its risks?
What would treatment involve — visits, monitoring, travel — and what could it cost?
How would we decide whether it’s working, and when we would stop?

Frequently asked questions

What is FDA expanded access?

FDA expanded access is a pathway that can allow a patient with a serious or immediately life-threatening condition to receive a medical product that is not yet FDA-approved, outside of a clinical trial, when no comparable or satisfactory alternative therapy is available. A licensed physician makes the request, the manufacturer must agree to provide the product, and the FDA reviews the request.

Is expanded access the same as compassionate use?

Yes. “Compassionate use” is the informal name for what the FDA formally calls expanded access. You may also see “early access,” “pre-approval access,” “named patient program,” or “managed access program” — they all describe a doctor requesting a not-yet-approved treatment for a patient’s care.

Can I apply for expanded access myself?

No. A licensed physician must submit the request and agree to oversee your treatment. What you can do is learn how the pathway works and bring your questions to your doctor to start the conversation.

What is Form FDA 3926?

Form FDA 3926 is the form a licensed physician can use to request expanded access for a single patient. The patient does not file it — the treating doctor submits it to the FDA, usually after the manufacturer has agreed to provide the product.

Can expanded access be authorized in an emergency?

Yes. For emergency requests, the FDA can authorize expanded access by phone or email, with the written request following afterward. The manufacturer still has to agree to provide the product.

How is expanded access different from Right to Try?

Both pathways require the manufacturer to agree to provide the product. Under expanded access, the FDA reviews each request and an Institutional Review Board (IRB) is generally involved. The federal Right to Try Act (2018) created a separate pathway that does not require FDA review of the individual request.

Sources & review

Last updated: October 7, 2026. Published by Right2Hope, a 501(c)(3) nonprofit. We accept no payment from sponsors for placement, and all patient services are free.

This page is for general information only and is not medical advice. Unapproved treatments have not been established as safe or effective. Always make treatment decisions with a licensed physician who knows your medical history.