TriangleWhat is the Right to Try Act, and what does it allow?
Right to Try tends to come up when the approved options are running out, and the name can sound like a guarantee. The federal law is narrower, and most of the decisions sit with a drug company and your doctor. Not medical advice.
This is not clinical evidence and not medical advice. It does not replace your care team. Discuss anything here with your clinician before you act on it. Product questions are on the FAQ.
What is the Right to Try Act?
This is not clinical evidence and not medical advice. It does not replace your care team. Discuss anything here with your clinician before you act on it. It is a federal law, signed on May 30, 2018, that gives some people with a life-threatening condition another way to ask for a drug still being studied. Its official name is the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, and Congress.gov lists it as Public Law 115-176. FDA describes it as one way for patients who have tried all approved treatment options and cannot join a clinical trial to access certain investigational treatments. The company has the last word. NCI's dictionary says companies that develop and make drugs decide whether to make them available to patients who qualify. Patients and their doctors work with that company directly, without involving FDA in the process, the agency's fact sheet says.
Who qualifies under the federal Right to Try Act?
Three things have to be true. The person has been diagnosed with a life-threatening disease or condition, a term the law takes from an existing FDA regulation. They have exhausted approved treatment options and cannot take part in a clinical trial of that drug. And they, or a legally authorized representative, have given the treating physician written informed consent about the drug. The second point has to be certified by a physician. The law asks for one who is in good standing with their licensing organization or board and who will not be paid directly by the manufacturer for certifying. If you are not sure whether your approved options are used up, that is a fair question for the doctor who would be signing.
Which drugs can be requested under Right to Try?
Only drugs still on the path to approval. Under the law, an eligible drug has completed a Phase 1 clinical trial and is not approved or licensed by FDA for any use. It has an application filed with FDA, or is in a trial meant to be the main evidence of effectiveness under an active investigational new drug application (IND). Its development has to be ongoing, not discontinued or placed on clinical hold. Whether one drug meets those tests is not something you can read off the law. FDA says the sponsor, the company developing the drug, is in the best position to say whether it qualifies. What a Phase 1 trial is, and what it tests, is on our page "Phase 1 cancer trials".
What does the Right to Try Act not do?
It does not make anyone hand over a drug. FDA says the law does not require a sponsor to provide an eligible investigational drug, and its fact sheet adds that FDA cannot require it either. The law itself says no sponsor, manufacturer, prescriber or dispenser can be held liable for deciding not to provide access. It is not a promise of a result. In its sense of the Senate section, the law says it does not create a new entitlement or a positive right for anyone, and that it will not, and cannot, create a cure or effective therapy where none exists. Cost is a separate question. NCI notes that insurance may not cover the cost of an experimental treatment received outside of a trial, so a fair question for your care team is who would pay, and for what.
What role does FDA play in a Right to Try request?
A small one. FDA does not review or approve Right to Try requests, and says its role is limited to receiving and posting certain information. Individual requests also do not need review or approval by an institutional review board (IRB), though the drug still has to meet the law's criteria. Normally, FDA's fact sheet says, the agency reviews the safety of each proposed use of an investigational drug through the IND process, and drugs provided under Right to Try are generally exempt from those reviews. What FDA does receive is a yearly report. The law has each manufacturer or sponsor send an annual summary of use, including doses supplied, patients treated and any known serious adverse events, and FDA posts a consolidated summary on its annual reporting page.
How is Right to Try different from expanded access?
Both are routes to an unapproved drug outside a clinical trial. The main difference is who signs off. For expanded access, also called compassionate use, NCI says an IRB or its representative and FDA must both approve the use, while Right to Try is not regulated by FDA. The law's sense of the Senate section calls Right to Try an alternative pathway alongside FDA's existing expanded access policies, so one does not replace the other. How expanded access works is covered on our page "ClinicalTrials.gov listings".
How does a Right to Try request get started?
With a doctor. NCI says the only way to get a drug through Right to Try is with the help of your doctor, who has to check with the company developing the drug on two things: whether the drug is eligible, and whether the company is willing to provide it, which it is not required to do. FDA points the same way, recommending that patients first consult their physician and that physicians consult the sponsor. Before any treatment, NCI says, there is an informed consent process meant to make sure you understand the potential risks and benefits. Under the law, that consent is written.
What does it mean that the drug is not FDA-approved?
Safety and effectiveness are still open questions. FDA's fact sheet says the agency has not determined whether drugs available under Right to Try are safe and whether there could be serious risks or side effects, or whether they can lead to any improvement in disease or symptoms. Experimental drugs may also have unknown serious side effects, NCI notes. The law's sense of the Senate section describes using experimental treatments under it as an informed assumption of risk. NCI calls a clinical trial the most common and preferred way to get an experimental drug.
What could I ask my care team before raising Right to Try?
A few questions can make the conversation concrete. You could ask whether a clinical trial of the drug is still open to you, and whether expanded access would fit better. You could also ask whether the drug has finished a Phase 1 trial and is still in active development, who would certify that approved options are exhausted, what the written consent would cover, and who would pay. FDA's own page frames Right to Try as a pathway to discuss with your doctor. "Questions to ask your oncologist" has a wider list, and "Joining a cancer clinical trial" covers the trial route. None of the government pages I read says whether Right to Try fits any one person, or how often companies say yes. Those answers sit with your doctor and the company developing the drug.
Sources
- Congress.gov: S.204, 115th Congress (2017-2018), Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017Congress.gov lists S.204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, as having become Public Law No: 115-176 on 05/30/2018.
- Public Law 115-176, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (GovInfo PDF, Sec. 1, 132 Stat. 1372; approval date, 132 Stat. 1375)The law's short title is the "Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017" and it was approved May 30, 2018 (Sec. 1; 132 Stat. 1372 and 1375).
- FDA: Right to Try (content current as of 12/12/2024)FDA says the Right to Try Act is one way for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial to access certain investigational treatment options.
- FDA Fact Sheet: Right to Try (PDF, 2 pages)FDA's fact sheet says that under Right to Try, patients and their doctors work with a company that is developing a drug or biologic to request access without involving FDA in the process.
- NCI Dictionary of Cancer Terms: Right to Try ActNCI's dictionary says companies who develop and make drugs determine whether to make their products available to patients who qualify for access under the Right to Try Act.
- Public Law 115-176, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (GovInfo PDF, sec. 561B(a)(1), 132 Stat. 1372)The law defines an eligible patient as one diagnosed with a life-threatening disease or condition (as defined in section 312.81 of title 21, Code of Federal Regulations), who has exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug, and who has provided to the treating physician written informed consent regarding the drug, or on whose behalf a legally authorized representative has provided such consent (new FD&C Act sec. 561B(a)(1)).
- Public Law 115-176, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (GovInfo PDF, sec. 561B(a)(1)(B), 132 Stat. 1372)The law says the exhaustion of approved options and inability to join a trial must be certified by a physician who is in good standing with the physician's licensing organization or board and who will not be compensated directly by the manufacturer for so certifying (sec. 561B(a)(1)(B)).
- Public Law 115-176, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (GovInfo PDF, sec. 561B(a)(2), 132 Stat. 1372-1373)The law defines an eligible investigational drug as one for which a Phase 1 clinical trial has been completed, that has not been approved or licensed for any use, for which an application has been filed or that is under investigation in a clinical trial intended to form the primary basis of a claim of effectiveness in support of approval and is the subject of an active investigational new drug application, and whose active development or production is ongoing and has not been discontinued by the manufacturer or placed on clinical hold (sec. 561B(a)(2)).
- FDA: Right to Try (content current as of 12/12/2024) (FAQ 2)FDA says the sponsor is in the best position to provide information about whether the drug or biological product meets the criteria to be considered an eligible investigational drug (FAQ 2).
- FDA: Right to Try (content current as of 12/12/2024) (FAQ 7)FDA says the Right to Try Act does not require a sponsor to provide an eligible investigational drug to an eligible patient (FAQ 7).
- FDA Fact Sheet: Right to Try (PDF, 2 pages)FDA's fact sheet says the Right to Try Act does not require a manufacturer or sponsor to provide access, and FDA cannot require a manufacturer or sponsor to provide access under the Act.
- Public Law 115-176, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (GovInfo PDF, Sec. 2(b)(2), 132 Stat. 1374)The law says no liability shall lie against a sponsor, manufacturer, prescriber, dispenser or other individual entity for its determination not to provide access to an eligible investigational drug (Sec. 2(b)(2)).
- Public Law 115-176, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (GovInfo PDF, Sec. 3, 132 Stat. 1374-1375)The law's sense of the Senate section says section 561B does not establish a new entitlement or modify an existing entitlement, or otherwise establish a positive right to any party or individual, and will not, and cannot, create a cure or effective therapy where none exists (Sec. 3(1) and 3(5)).
- NCI: Ways to Access Experimental Cancer Drugs (reviewed January 13, 2022)NCI says your insurance may not cover the cost of an experimental treatment received outside of a trial (Deciding on treatment with an experimental drug).
- FDA: Right to Try (content current as of 12/12/2024) (FAQ 3)FDA says it does not review or approve requests for Right to Try Act use, and that its role is limited to receipt and posting of certain information submitted under the Act (FAQ 3).
- FDA: Right to Try (content current as of 12/12/2024) (FAQ 5)FDA says individual Right to Try Act requests do not require IRB review or approval, but eligible investigational drugs must meet certain criteria (FAQ 5).
- FDA Fact Sheet: Right to Try (PDF, 2 pages)FDA's fact sheet says that through the IND application process FDA typically reviews the safety of each proposed use of an investigational new drug before it can be provided to patients, and that drugs provided through the Right to Try pathway are generally exempt from these IND reviews.
- Public Law 115-176, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (GovInfo PDF, sec. 561B(d)(1), 132 Stat. 1373-1374)The law says the manufacturer or sponsor of an eligible investigational drug shall submit an annual summary of any use of the drug, including the number of doses supplied, the number of patients treated, the uses for which the drug was made available, and any known serious adverse events (sec. 561B(d)(1)).
- FDA: Right to Try Annual Reporting Summary (content current as of 07/22/2026)FDA's annual reporting page says FDA receives annual summaries from manufacturers or sponsors and that its table includes a consolidated annual summary report of Right to Try Act use.
- NCI: Ways to Access Experimental Cancer Drugs (reviewed January 13, 2022)NCI says expanded access is also called compassionate use, and that for expanded access an Institutional Review Board or its representative must approve the use and the FDA must approve the use.
- NCI: Ways to Access Experimental Cancer Drugs (reviewed January 13, 2022)NCI says right to try, like expanded access, allows the use of an experimental drug outside of clinical trials to treat people with serious or life-threatening diseases, but unlike expanded access, it is not regulated by the FDA.
- Public Law 115-176, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (GovInfo PDF, Sec. 3(4), 132 Stat. 1374-1375)The law's sense of the Senate section says section 561B is consistent with, and will act as an alternative pathway alongside, existing expanded access policies of the Food and Drug Administration (Sec. 3(4)).
- NCI: Ways to Access Experimental Cancer Drugs (reviewed January 13, 2022)NCI says the only way to obtain a drug through right to try is with the help of your doctor, who will need to consult with the company developing the drug to find out if the drug is eligible and if the company is willing to provide it, which it is not required to do.
- FDA: Right to Try (content current as of 12/12/2024) (FAQ 1)FDA recommends that patients first consult with their physician and that physicians consult with the sponsor of the investigational drug or biological product (FAQ 1).
- NCI: Ways to Access Experimental Cancer Drugs (reviewed January 13, 2022)NCI says that before you are treated with a drug through right to try, you will go through an informed consent process to ensure that you understand the potential risks and benefits.
- FDA Fact Sheet: Right to Try (PDF, 2 pages)FDA's fact sheet says FDA has not determined whether drugs and biologics made available under Right to Try are safe and if there could be serious risks or side effects, and has not determined whether they can lead to any improvement in disease or symptoms.
- NCI: Ways to Access Experimental Cancer Drugs (reviewed January 13, 2022)NCI says there may be unknown serious side effects with experimental drugs.
- Public Law 115-176, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (GovInfo PDF, Sec. 3(6), 132 Stat. 1375)The law's sense of the Senate section says use of experimental treatments under the criteria and procedure it describes involves an informed assumption of risk (Sec. 3(6)).
- NCI: Ways to Access Experimental Cancer Drugs (reviewed January 13, 2022)NCI says the most common and preferred way to access an experimental drug is through a clinical trial.
- FDA: Right to Try (content current as of 12/12/2024)FDA's Right to Try page says that if you are interested in Right to Try, you should discuss this pathway with your doctor.