Right to Try
Right to Try is a U.S. legal pathway that can let some people with life-threatening conditions seek certain investigational drugs outside a clinical trial. It does not make an experimental product available on demand: drug makers may decline, and the law does not approve a drug or guarantee access to psilocybin.
- U.S. law
- Federal law enacted in 2018
- Who qualifies
- Some patients with life-threatening conditions
- Drug access
- Manufacturers can say no
- Psilocybin
- No automatic access under this law
- Other routes
- Clinical trials or expanded access
What does Right to Try mean?
Right to Try refers to U.S. laws that create a route for some seriously ill people to request investigational drugs outside a clinical trial. The federal law, signed in 2018, applies to eligible patients with a life-threatening condition who have run out of approved options and cannot take part in a clinical trial. The drug must meet legal requirements, including having completed an early stage of testing. It is still experimental, not an approved medicine.
States began passing their own Right to Try laws before the federal law existed. State rules differ, and the federal law established a separate national pathway for qualifying investigational drugs. Neither type of law guarantees that a person will receive a requested product. A physician must be involved, and the drug's manufacturer must agree to provide it. The laws are about access requests, not a general permission to buy, possess, or use any unapproved drug.
- 1Review eligibility
A physician considers the patient's condition, options, and ability to join a clinical trial.
- 2Check the drug
Confirm the investigational drug meets federal Right to Try requirements.
- 3Contact sponsor
The patient or physician asks the manufacturer whether it will provide the drug.
- 4Discuss consent
If the company agrees, the patient reviews uncertainties and gives informed consent.
- 5Arrange access
The physician and company coordinate use and applicable reporting.
How does the Right to Try pathway work?
The process starts with a conversation between a patient and a physician about the person's condition, available options, and eligibility. The physician checks whether the patient meets the legal criteria and whether a particular investigational drug is eligible. The drug must have completed Phase 1 testing, an early research stage that looks chiefly at safety. It also must meet other requirements under federal law, including that its study program has not been stopped.
Next, the physician or patient must approach the company that makes the drug. The company can choose whether to provide it, and the law does not require a positive answer. If it agrees, the patient gives informed consent and the treatment is arranged under applicable rules. The federal pathway has reporting requirements for companies, but it does not use the same FDA review of each request as expanded access. Patients can ask their clinician or a qualified legal professional how rules apply to their situation.
The pathway can allow eligible patients to seek a drug outside a clinical trial.
Each federal Right to Try request does not receive the same FDA review as expanded access.
A manufacturer may decline to provide the investigational drug.
Editorial placement to help compare; not a measurement.
Why does Right to Try matter for psilocybin?
Right to Try is often discussed as a way to seek experimental options when standard choices are limited. Supporters value the chance to ask about a drug still being studied. Critics point out that early research leaves important uncertainties, and that a law cannot make a company supply a product. Either way, a request is not proof that a drug is safe or effective for a particular person, and access may involve costs and practical barriers.
Searches for “right to try psilocybin” can blur together different legal routes. Psilocybin remains a Schedule I substance under federal law. Right to Try does not itself approve psilocybin or automatically override federal controlled-substance requirements. Supervised access is available through state programs in Oregon and Colorado; New Mexico's medical program is being established. Those state programs are distinct from Right to Try. Clinical trials and FDA expanded access are also separate pathways, each with its own eligibility and regulatory requirements.
| Right to Try | Expanded access | Clinical trial | |
|---|---|---|---|
| Main setting | Outside a clinical trial | Outside a clinical trial | Structured research study |
| FDA role | No review of each request | FDA reviews access requests | FDA oversees study rules |
| Supplier choice | Manufacturer may decline | Company may decline | Study must be enrolling |
| Eligibility | Federal legal criteria apply | Case-specific criteria apply | Study criteria apply |
What are common misconceptions and safety concerns?
A common misconception is that Right to Try gives a patient an enforceable right to any experimental treatment. It does not. A physician does not have to prescribe a product, a manufacturer does not have to supply it, and an insurer does not have to cover the costs. The law also does not turn an investigational drug into an FDA-approved treatment. Availability depends on legal eligibility, a willing supplier, and the circumstances of the individual request.
Another misconception is that an investigational product is safe simply because it has been studied. Early testing cannot answer every question about risks or possible benefit, especially for people with complex health needs. A patient should discuss known and unknown risks with a qualified clinician and make sure consent is informed. This glossary is general education, not medical or legal advice. Psilocybin's federal Schedule I status is an additional legal issue, not something Right to Try removes.
- 2014
Colorado became the first state to enact a Right to Try law.
- 2017
The U.S. Senate passed a federal Right to Try bill.
- 2018
The federal Right to Try Act was signed into law.
- 2023
Montana expanded its state law to include non-terminal patients.
How does Right to Try connect to mushroom topics?
The connection to mushrooms is mainly about psilocybin, a compound found in some fungi. Research settings may study psilocybin under regulatory permissions, but that does not make mushroom products legally available through Right to Try. A study, a state-supervised program, FDA expanded access, and a Right to Try request are different things. Their rules, eligibility, and oversight are not interchangeable, so a headline about one route should not be taken as evidence of access through another.
For related reading, it helps to separate the legal topic from mushroom biology and from claims about psychedelic experiences. Psilocybin is a chemical associated with certain mushroom species; Schedule I describes its federal legal classification, not a mushroom's identity. State policies also do not make wild mushrooms safe to identify or consume. Never eat a wild mushroom without expert identification. Readers can explore the linked guides on psilocybin, state measures, and controlled-substance law for more context.
Common questions about Right to Try
What is the Right to Try law?
It is a U.S. legal pathway that lets some patients with life-threatening conditions request certain investigational drugs outside clinical trials. The federal law has eligibility requirements, including that the drug has completed Phase 1 testing. It does not require a physician to prescribe the drug or a manufacturer to provide it.
Does Right to Try guarantee access to an experimental drug?
No. Patients must meet the relevant legal criteria, and a physician must be involved. The manufacturer can still refuse to supply the product, and insurance may not cover costs. The pathway also does not make an experimental drug FDA-approved or establish that it is safe or effective for an individual.
Can I use Right to Try to access psilocybin?
Right to Try does not automatically provide access to psilocybin or remove its federal Schedule I status. State-supervised access exists in Oregon and Colorado, while New Mexico's medical program is being established. Clinical trials and FDA expanded access are separate routes with their own requirements.
How is Right to Try different from expanded access?
Both can involve access to an investigational drug outside a clinical trial, but they are separate legal pathways. Under expanded access, the FDA reviews a request and other conditions apply. The federal Right to Try pathway does not involve the same FDA review of each request. A clinician can explain which route, if any, may fit a person's circumstances.
Related terms
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Sources and further reading
Written by the Pscilly editorial team and reviewed November 2026. Educational content only, not medical or legal advice. Pscilly does not sell psilocybin. Never eat a wild mushroom without expert identification.