The Right to Try Act is a 2018 federal law that lets terminally ill patients request experimental drugs directly from the manufacturer, without going through the FDA’s authorization process. Its full name is the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, signed as Public Law 115-176 in May 2018. More than 40 states had passed their own versions first; the federal statute set a nationwide floor. In practice, few patients have used the pathway, and the manufacturer, not the government, decides whether to say yes.
Who Qualifies as an Eligible Patient
Three conditions have to be met. The patient must have a “life-threatening disease or condition,” which federal regulations define as a disease where death is likely unless the disease is interrupted, or a condition with a potentially fatal outcome where survival is the endpoint of clinical analysis.1eCFR. 21 CFR 312.81 – Life-Threatening Disease Definition That definition is broader than the “six months to live” phrasing many people expect.
The patient must also have exhausted approved treatments and be unable to enroll in a clinical trial for the drug in question, whether because no trial is enrolling, the patient doesn’t meet the criteria, or no site is within reach. And the patient must give written informed consent to the treating physician.2Legal Information Institute. 21 USC 360bbb-0a – Eligible Patient Definition
The certifying physician has to be in good standing with their licensing board and cannot be paid by the drug’s manufacturer for making the certification.2Legal Information Institute. 21 USC 360bbb-0a – Eligible Patient Definition That compensation ban is meant to keep financial interest out of the eligibility decision.
Which Drugs Qualify
Not every investigational drug is available through this pathway. The drug must have completed a Phase 1 clinical trial, which is the earliest human safety and dosing stage. It must be the subject of an active Investigational New Drug application on file with the FDA, and its manufacturer must be actively working to bring it toward approval.3U.S. Food and Drug Administration. Right to Try
Two categories are excluded. Drugs whose development the manufacturer has abandoned don’t qualify, because the statute requires ongoing production or development. Drugs the FDA has placed on clinical hold, meaning a safety pause, are also excluded.3U.S. Food and Drug Administration. Right to Try The clinical-hold exclusion is one of the few built-in safety guardrails.
How to Request an Investigational Drug
The request goes to the manufacturer, not to the FDA. The patient’s physician contacts the company, documents the patient’s eligibility, and asks the company to supply the drug. The FDA is not involved in the decision, and its role afterward is limited to receiving annual summary reports from manufacturers who choose to participate.3U.S. Food and Drug Administration. Right to Try
Here is what many people miss: the manufacturer has absolute discretion to refuse. The law does not require any company to provide its drug, even when a patient meets every statutory criterion. There is no appeal, whether to the FDA, a court, or an administrative body, and the statute expressly protects companies from liability for declining a request.4GovInfo. 21 USC 360bbb-0a – Investigational Drugs for Use by Eligible Patients
Companies decline for reasons that often have nothing to do with the patient: limited drug supply that could jeopardize ongoing trials, worry that a bad outcome in a very sick patient could complicate the approval path, or no infrastructure to manage one-off treatments outside a trial. In the first year after the law passed, publicly confirmed cases of patients receiving drugs through this pathway could be counted on one hand.
What It Costs and What Insurance Won’t Cover
The financial exposure is where this pathway trips patients up. The law lets manufacturers charge for the costs of providing the drug, and unlike the FDA’s Expanded Access program, there is no regulated cap on those charges and no independent accountant verifying them.5eCFR. 21 CFR 312.8 – Charging for Investigational Drugs Under an IND Some manufacturers provide the drug at no charge. They don’t have to.
Insurance is the bigger problem. Nothing in the Right to Try Act requires any insurer, Medicare, or Medicaid to pay for the drug or for the care around administering it. Medicare and Medicaid do not cover drugs that lack FDA approval, and they cover care tied to investigational treatments only when the patient is in a qualifying clinical trial, which a Right to Try patient by definition is not. Commercial policies frequently exclude experimental or investigational treatments outright.
The bills that can pile up aren’t just for the drug. Infusion services, monitoring, lab work, hospitalization if something goes wrong, and treatment of side effects may all fall outside coverage. Before proceeding, review your policy’s exclusions and get written confirmation from the insurer about what will and won’t be paid.
Informed Consent and Liability
Written informed consent from the patient (or a legal representative) to the treating physician has to happen before treatment begins. The statute doesn’t prescribe a template or list required disclosures. It only requires written consent “regarding the eligible investigational drug.”2Legal Information Institute. 21 USC 360bbb-0a – Eligible Patient Definition
A meaningful consent form should say that the drug is not FDA-approved, that its safety and effectiveness are unknown, and that adverse outcomes, including worsening of the patient’s condition, are possible. Physicians and manufacturers write their own forms. Some state Right to Try laws impose more specific disclosure rules than the federal statute. Because there is no Institutional Review Board reviewing this pathway, the responsibility for making sure the patient truly understands the risks sits entirely with the treating physician.
The liability shield in the statute is tiered. Manufacturers and sponsors get the broadest protection: no cause of action can be brought against them for any act or omission tied to an eligible drug provided under the law. Prescribers, pharmacists, and others involved in treatment also get protection, but they can still be held liable for reckless or willful misconduct, gross negligence, or an intentional tort under state law.4GovInfo. 21 USC 360bbb-0a – Investigational Drugs for Use by Eligible Patients
One caveat worth knowing. The statute says it does not modify any existing right to sue under state or federal product liability, tort, consumer protection, or warranty law.4GovInfo. 21 USC 360bbb-0a – Investigational Drugs for Use by Eligible Patients The Right to Try immunity covers claims arising from the Right to Try pathway itself; it does not wipe out every other legal theory. How courts will draw that line is largely untested.
How Right to Try Compares to FDA Expanded Access
The FDA has run an Expanded Access program for decades. It also lets patients with serious or life-threatening conditions use investigational drugs outside a clinical trial, and the agency approves the great majority of requests. For device-related expanded access in fiscal year 2023, the approval rate ran between 98.6% and 100%.6U.S. Food and Drug Administration. Expanded Access (Compassionate Use) Submission Data The historical bottleneck has been paperwork on physicians and manufacturers, not agency rejections.
The structural differences between the two pathways matter:
- FDA review. Expanded Access requires FDA authorization for each use. Right to Try bypasses FDA review; the agency only receives annual reports after the fact.3U.S. Food and Drug Administration. Right to Try
- Ethics oversight. Expanded Access generally requires review by an Institutional Review Board. Right to Try does not.3U.S. Food and Drug Administration. Right to Try
- Cost controls. Under Expanded Access, manufacturers need prior FDA authorization to charge patients and can only recover certain direct costs verified by an independent accountant. Under Right to Try, those FDA cost-recovery rules don’t apply.5eCFR. 21 CFR 312.8 – Charging for Investigational Drugs Under an IND
- Drug stage. Both require active development, but Right to Try specifically requires a completed Phase 1 trial, while Expanded Access can sometimes reach drugs at earlier stages with FDA authorization.
Right to Try trades layers of oversight for a shorter path. Whether that trade helps a specific patient depends on the specific situation. For many patients, an Expanded Access request through the treating physician turns out to be the more practical route: near-universal approval, safety oversight, and cost controls the newer law doesn’t provide.
Practical Limits Before You Choose This Path
The gap between what the law promises and what it delivers is real. It removes regulatory hurdles but doesn’t fix the reason most patients can’t get experimental drugs: manufacturers often have limited supply and strong reasons to reserve it for the trials that generate approval data.
The safety-review layers the law removed, FDA authorization and IRB oversight, weren’t replaced with anything. For a patient facing a terminal diagnosis, that may be an acceptable trade. It also means no one outside the treating physician and the manufacturer is independently evaluating whether the drug fits that patient at that stage of illness.
Before pursuing Right to Try, have a direct conversation with your physician about whether an Expanded Access request would fit your situation better. Ask the manufacturer, in writing, whether it will supply the drug and on what terms. And confirm with your insurer, in writing, what portion of the drug and the surrounding care it will cover. Those three answers usually decide whether this pathway is realistic for you.