What Is Expanded Access?

A plain-language guide to compassionate use programs — who qualifies, how to apply, and how to find programs for your condition.

Expanded access — often called compassionate use — is an FDA pathway that lets a patient with a serious or life-threatening condition receive an investigational treatment outside of a clinical trial, when no approved treatment is working and joining a trial isn’t possible.

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 how to find real programs for your condition — free — using Right2Hope, a 501(c)(3) nonprofit.

What is expanded access?

New treatments are normally only available inside clinical trials until the FDA approves them. But many people can’t join a trial — the trial may be full, too far away, or its entry criteria may exclude them. Expanded access exists for exactly this gap: it allows a doctor to request an investigational 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.

One honest caveat before anything else: investigational 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 qualifies 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 unable to join a clinical trial of the treatment.
Your doctor judges that the potential benefit justifies the risks for your situation.

Quick self-check

Could expanded access be worth discussing with your doctor?

Four questions, no data collected. This is not medical advice and does not determine eligibility.

1. Has a doctor diagnosed you (or the person you care for) with a serious or life-threatening condition?
2. Have the standard, approved treatments been tried, or ruled out by your care team?
3. Have you been unable to join a clinical trial for this condition — for example, because of eligibility criteria or distance?
4. Do you have a doctor who could oversee treatment and handle the application with you?

How to apply for expanded access, step by step

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

Identify a potential treatmentFind the investigational drug or program that targets your condition. This is where a program search helps — see the walkthrough below.
Talk with your doctorA licensed physician must agree that expanded access is appropriate and be willing to oversee your treatment and reporting.
Your doctor asks the manufacturerThe company that makes the treatment must agree to provide it. Companies can and do say no — supply, ongoing trials, and fairness policies all factor in.
Your doctor submits to the FDAFor an individual patient, this is usually Form FDA 3926 — a short form designed to take a physician about 45 minutes.
IRB review and informed consentAn institutional review board (an independent ethics committee) reviews the plan, and you sign an informed consent form before treatment begins.

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 investigational 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 program or sponsor may still be open. Practical takeaway: don’t stop at one request. Search broadly for programs that match your condition — different companies run different programs with different 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 investigational products, and the surrounding care — infusions, imaging, monitoring visits — may be billed normally.

Ask the sponsor whether the drug itself is provided free of charge.
Ask your care team what related care will be billed, and to whom.
Everything Right2Hope does — search, matching, 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.

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
Ethics (IRB) review	Yes	Not required
Eligible treatments	Any investigational 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

How to find expanded access programs on Right2Hope

Knowing the pathway exists is half the problem — the other half is finding out which programs exist for your condition right now. Right2Hope maintains a free, continuously updated index of thousands of expanded access programs and clinical trials from hundreds of sponsors. Here’s the whole flow:

Search by your conditionType your diagnosis into the program search (for example, “ovarian cancer” or a drug name), or browse the curated hubs like programs by cancer type.
Review your matches in plain languageEvery program page includes a patient-friendly summary of what the treatment is, who it’s for, and its status — no medical degree required. Save the ones that fit.
Bring the list to your doctorEmail yourself the program details and take them to your next appointment. Because your physician must make the request, arriving with specific programs turns “is there anything else?” into “can we apply for this?”

You can also create a free account to get proactive alerts when new programs matching your profile open — programs launch and close constantly, and the right one may not exist yet today.

Free nonprofit search

Find programs for your condition

Search thousands of expanded access programs and clinical trials — free, from a 501(c)(3) nonprofit.

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?
Is there a clinical trial I could join instead? (Trials are usually the better first option.)
Would you be willing to oversee an expanded access request for me?
What do you know about this specific program or drug, 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

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 using an investigational treatment outside a clinical trial.

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 research programs for your condition, contact program sponsors, and bring that information to your doctor to start the conversation.

Does the FDA usually say yes?

Yes — the FDA authorizes about 99% of the expanded access requests it receives. The step most likely to stop a request is the drug company’s decision, since the manufacturer must agree to supply its investigational treatment.

Will insurance pay for an expanded access treatment?

Usually not. Most insurers do not cover investigational products. Companies often provide the drug free of charge, and FDA rules only allow them to charge their direct costs — never a profit. Related care, such as infusion visits or monitoring, may still be billed to you or your insurer, so ask about all costs up front.

How fast can expanded access happen in an emergency?

In an emergency, the FDA can authorize treatment over the phone and treatment may begin immediately, with paperwork following afterward. Non-emergency individual requests are typically reviewed within days to weeks.

Is an investigational treatment guaranteed to help me?

No. Investigational treatments have not been proven safe or effective — that is what the ongoing research is trying to find out. They may not help and can cause serious, sometimes unexpected, side effects. Weighing that risk with your doctor is a required and important part of the decision.

Sources & review

Last updated: June 22, 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. Investigational treatments have not been established as safe or effective. Always make treatment decisions with a licensed physician who knows your medical history.