What Is Right to Try?

A plain-language guide to the federal Right to Try law — who qualifies, which drugs are eligible, and how it differs from expanded access.

Right to Try is a federal law (2018) that lets a patient with a life-threatening condition ask a drug company directly for an investigational drug that has completed a Phase 1 trial — without applying to the FDA and without review by an ethics board.

This guide explains the law in plain language: who qualifies, which drugs are eligible, how the process works, what it costs, and how it compares to expanded access — the older FDA pathway most patients use instead. Right2Hope is a 501(c)(3) nonprofit; everything we do for patients is free.

What is the Right to Try law?

The law’s full name is the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, signed on May 30, 2018 and named for four patients who fought for it. It created a second federal pathway to investigational drugs — one that deliberately works outside FDA case-by-case review. Most states had already passed their own right-to-try laws (41 by 2018); the federal law made the pathway nationwide.

Two honest framings matter before the details. First, Right to Try is a right to ask, not a right to receive — the drug company decides, and it doesn’t have to say yes. Second, investigational drugs are unproven: a Phase 1 trial mainly tests safety in a small group, not whether the drug works. The law removes regulatory review; it does not add evidence.

In practice the pathway is used rarely. Manufacturers report Right to Try use to the FDA annually, and the reported numbers since 2018 have been small — while the FDA’s expanded access pathway handles more than a thousand authorized requests every year. For many patients, expanded access is the more realistic route, which is why comparing the two is worth your time (see the comparison below).

Who qualifies for Right to Try?

Under the federal law, all of the following must be true:

You have been diagnosed with a life-threatening disease or condition. (Expanded access is broader — it also covers “serious” conditions.)
You have exhausted approved treatment options and are unable to participate in a clinical trial of the drug — certified by a physician in good standing who is not paid by the manufacturer for that certification.
You have given written informed consent to your treating physician.

Which drugs are eligible?

Not every experimental treatment qualifies. Under the law, an eligible investigational drug must meet all three tests:

It has completed a Phase 1 clinical trial.
It has not been approved or licensed by the FDA for any use.
It is still in active development — an approval application has been filed, or the drug is under investigation in a trial intended to support approval.

A drug whose development was abandoned, or one already approved for another condition, does not qualify under Right to Try. (An approved drug can often be prescribed off-label instead — a different conversation to have with your doctor.)

How Right to Try works, step by step

There is no FDA application form and no ethics-board review — which makes the process short on paper. The steps that remain are the ones that decide the outcome:

Confirm you qualify — with your doctorA physician in good standing must certify that your condition is life-threatening, that you have exhausted approved treatment options, and that you cannot participate in a clinical trial of the drug. The law bars the certifying doctor from being paid by the manufacturer for that certification.
Confirm the drug qualifiesThe drug must have completed a Phase 1 clinical trial, not be FDA-approved for any use, and still be in active development toward approval. Many treatments patients ask about do not meet all three tests — checking early saves weeks.
Give written informed consentYou must provide written informed consent to your treating physician acknowledging the risks of an investigational product.
Your doctor asks the manufacturerThere is no FDA application and no ethics-board review. The request goes straight to the company — which is free to say yes or no. Its decision is the real gate.
Treatment and reportingIf the company agrees, treatment proceeds under your doctor’s care. The manufacturer reports Right to Try use to the FDA once a year in a summary — individual outcomes are not reviewed case by case.

How often is Right to Try actually used?

Far less than the attention around the law suggests. Skipping FDA review sounds faster, but the FDA was never the bottleneck — it authorizes about 99% of expanded access requests, and can approve emergencies over the phone. The manufacturer’s decision gates both pathways equally.

1,000+

expanded access requests are authorized by the FDA every year — about 99% of those it receives.

Dozens

of patients per year are reported treated under Right to Try in manufacturers’ annual FDA summaries.

None of this means Right to Try is never the right choice — it exists, it is legal nationwide, and for some patients it has been the path that worked. It means the smart move is to pursue it alongside the alternatives, not instead of them.

What does Right to Try cost?

The same charging rule as expanded access applies: manufacturers may charge no more than their direct costs of providing the drug — profit is not allowed — and some provide it free. Insurance generally does not cover investigational products, and the care around treatment (infusions, imaging, monitoring, hospital time) may be billed normally.

Ask the manufacturer whether the drug is provided free or at direct cost.
Ask your care team what related care will be billed, and to whom.
Everything Right2Hope does — search, matching, guidance — is free for patients, always.

Right to Try vs. expanded access

The two pathways are easy to confuse and often discussed together. The practical differences that matter to a patient:

Comparison of Right to Try and expanded access pathways
	Right to Try	Expanded access
Who is eligible	Life-threatening condition only	Serious or life-threatening condition
FDA involved?	No FDA review	Yes — reviews and authorizes (≈99% authorized)
Ethics (IRB) review	Not required	Yes
Eligible treatments	Drugs that completed Phase 1 and remain in active development	Any investigational drug, biologic, or device
Company must agree	Yes	Yes
Safety oversight	Your doctor	FDA + IRB + your doctor
Emergency option	None defined in the law	FDA can authorize by phone; treatment may start immediately

Which should you pursue? Discuss both with your doctor — they are not mutually exclusive. Clinical trials remain the best first option when one fits, and our expanded access guide walks through the pathway most patients use.

Find treatments in development for your condition

Whether the right pathway turns out to be a clinical trial, expanded access, or Right to Try, the starting point is the same: knowing which investigational treatments exist for your condition right now. Right2Hope maintains a free index of thousands of programs from hundreds of sponsors — search it, save what fits, and bring the list to your doctor.

Free nonprofit search

Search treatments for your condition

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 determine whether Right to Try can move forward:

Is my condition considered life-threatening under the law’s definition?
Is there a clinical trial or an expanded access program I should consider first?
Has the drug I’m interested in completed Phase 1 — and is it still in development?
Would you be willing to certify my eligibility and oversee treatment?
What is known — and not known — about this drug’s risks at this stage?
What would treatment cost, and who would bill me for the care around it?

Frequently asked questions

Is Right to Try the same as expanded access?

No. They are two separate legal pathways to investigational treatments. Right to Try (federal law since 2018) does not involve the FDA or an ethics board in individual decisions, and it is limited to life-threatening conditions and drugs that have completed a Phase 1 trial. Expanded access is the older FDA pathway, covers more situations, and includes FDA and IRB review.

Do I apply to the FDA for Right to Try?

No. Right to Try was designed to work outside FDA case-by-case review. Your doctor certifies that you qualify and requests the drug directly from the manufacturer. The FDA does not approve or deny individual Right to Try requests.

Does the drug company have to say yes?

No. The law gives you a right to ask, not a right to receive. The manufacturer decides whether to provide its investigational drug and is under no legal obligation to do so — the same practical bottleneck as expanded access.

What does Right to Try cost?

Manufacturers may charge no more than their direct costs of providing the drug, and some provide it free. Insurance generally does not cover investigational products, and related care — infusions, monitoring, hospital time — may be billed normally. Ask about all costs before starting.

How many people have used Right to Try?

Relatively few. Manufacturers report Right to Try use to the FDA in annual summaries, and the reported numbers since 2018 are small — a tiny fraction of the volume of the expanded access pathway, which the FDA authorizes more than a thousand times each year.

Is Right to Try available in my state?

Yes. The 2018 federal law applies nationwide. Most states also passed their own right-to-try laws before the federal act — 41 states had them by 2018 — but the federal law is what matters practically today.

Sources & review

Last updated: July 31, 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.