Right to Try legislation is enacted in the United States

The law, and what it is called

The statute is Public Law 115-176. Its full name is the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017. It was signed on May 30, 2018, and it began as Senate bill 204.

The names are those of people with serious illness who campaigned for it. That is worth keeping in view, because the law is often discussed as a slogan rather than as a piece of text with conditions in it.

Those conditions are the whole story. The Act adds a new section to the Federal Food, Drug, and Cosmetic Act. It lets a manufacturer supply an unapproved drug straight to a patient, outside a trial. FDA does not review that individual request.

Who counts as an eligible patient

The law sets three tests, and all three have to be met.

The person must have a life-threatening disease or condition, as that term is defined in federal regulation.

They must have exhausted approved treatment options and be unable to join a clinical trial of the drug. A physician has to certify both. That physician must be in good standing with their licensing board, and must not be paid by the manufacturer for making the certification.

And the person, or their legally authorized representative, must give written informed consent to the treating physician. Our page on informed consent covers what genuine consent requires.

Which drugs qualify

The drug side is narrower than most people expect. An eligible investigational drug must meet four conditions at once:

• A Phase 1 clinical trial of it has been completed.
• It has not been approved or licensed by FDA for any use.
• An application has been filed with FDA, or it is in a trial intended to support approval, and it is covered by an active investigational new drug application.
• Its development or production is still going, and it has not been discontinued by the manufacturer or placed on clinical hold by FDA.

So a compound abandoned by its maker does not qualify. Nor does one halted for safety. Nor does anything that has never reached a trial at all.

What "Phase 1 completed" does and does not establish

This is the most misread part of the law.

A Phase 1 trial asks whether a drug can be given to people at all. It is usually small, often a few dozen participants, and its job is to find a tolerable dose and describe short-term side effects. It is not designed to show that the drug works.

Phase 2 looks for signs of activity in a specific disease. Phase 3 compares the drug against current standard treatment in a much larger group, and that is where benefit is actually established or disproved. Our page on clinical trial phases walks through each stage.

Most drugs that complete Phase 1 never reach approval. "Passed Phase 1" therefore means "has been given to humans without unacceptable immediate harm at some dose". It does not mean "likely to help".

Expanded access, the older route

FDA has run an expanded access program, often called compassionate use, for more than three decades. It remains available and is not replaced by Right to Try.

Under expanded access, FDA considers the request. Its criteria are set out on the FDA site. The person has a serious or immediately life-threatening condition. There is no comparable or satisfactory alternative. A trial is not possible. The likely benefit justifies the risk. And supplying the drug will not derail the trials needed to get it approved.

For cancer specifically, FDA runs Project Facilitate, an oncology call center and email service for these requests. Our page on expanded access and compassionate use explains how a request is put together.

The practical difference is who decides. Under Right to Try, the manufacturer decides alone, and FDA's role is limited to receiving and posting certain information afterwards.

The part the law does not do

Right to Try creates a permission, not an entitlement. It removes a regulatory step. It does not require any company to supply anything.

FDA states this plainly: companies developing drugs for life-threatening conditions decide for themselves whether to make a product available under the law.

Nor does the law address cost, insurance coverage, shipping, storage, who administers the drug, or who manages the side effects. Those all remain the patient's and the treating team's problem.

If you are looking into this

FDA's advice is a sequence, and it is the practical starting point.

• Talk to your own doctor first, since the certification has to come from a physician who knows your case.
• Ask the doctor to contact the drug's sponsor. Only the sponsor can say whether a specific product is an eligible investigational drug and whether it will be supplied.
• Ask at the same time whether a clinical trial is genuinely closed to you, since eligibility for Right to Try depends on that.
• Ask about expanded access as a parallel route, and for cancer drugs about Project Facilitate.
• Get the cost in writing before agreeing to anything.

What this does not mean

It does not mean a promising drug is available on request. Every step depends on a company saying yes.

It does not mean the drug will work. A Phase 1-complete drug has no established benefit, by definition.

It does not mean the drug is safe. Serious and unexpected side effects are exactly what later trials exist to find.

And FDA's public reporting under the Act counts products rather than patients, so the number of people treated under this law cannot be read off the official summary.

Sources

• Public Law 115-176, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, full text — https://www.govinfo.gov/content/pkg/PLAW-115publ176/html/PLAW-115publ176.htm
• FDA, Right to Try — https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try
• FDA, Expanded Access — https://www.fda.gov/news-events/public-health-focus/expanded-access
• FDA Oncology Center of Excellence, Project Facilitate — https://www.fda.gov/about-fda/oncology-center-excellence/project-facilitate
• FDA, Right to Try Annual Reporting Summary — https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try-annual-reporting-summary
• NCI, Phases of Clinical Trials — https://www.cancer.gov/about-cancer/treatment/clinical-trials/what-are-trials/phases

How this article was prepared

An AI-assisted editorial system helped prepare this page. No named medical reviewer has reviewed it unless one is listed.

The National Cancer Information Foundation publishes Cancer Explained. This page is for learning. It is not medical advice and does not suggest a test or treatment.

See an error, old source, or unclear wording? Tell us.