Definition of Right To Try
Political Dictionary
Right to Try
A federal law signed by President Trump in May 2018 that lets terminally ill Americans request access to experimental drugs that have not yet been approved by the FDA, provided the drug has passed Phase I safety testing and is still in active clinical development. It is a permission slip, not a guarantee - the drug manufacturer can still refuse, insurance is not required to cover the cost, and no doctor is obligated to prescribe.
What Does The Term Mean?
What is the Right to Try Act?
The Right to Try Act of 2017 (signed into law on May 30, 2018) created a federal pathway for terminally ill patients to access investigational drugs that the Food and Drug Administration has not yet approved.
Before the law existed, a dying patient who wanted access to an experimental drug had to go through the FDA's Expanded Access program (also known as "compassionate use"), which has been around since the 1980s. Their doctor would fill out a form, the FDA would review it, and either give a green light or a red light.
The Right to Try Act removes the FDA from that equation. Under the law, the patient, the doctor, and the drug company can deal directly with each other - no FDA permission required. The argument from supporters was simple: a dying patient should not have to wait for a federal bureaucracy to give them permission to fight for their life.
The catch - and it is a big one - is that the law does not give anyone the right to actually receive a drug. It only gives them the right to ask for one. The drug manufacturer can say no. Insurance companies can refuse to cover it. The patient often pays out of pocket. And if something goes wrong, the law shields nearly everyone involved from being sued.
The full legal name of the law is the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (P.L. 115-176). It is named after four patients with ALS or Duchenne muscular dystrophy who became the public face of the campaign to pass it. The law was championed by the Goldwater Institute, a libertarian think tank based in Arizona that drafted the model legislation states had been adopting since 2014.
Before the law existed, a dying patient who wanted access to an experimental drug had to go through the FDA's Expanded Access program (also known as "compassionate use"), which has been around since the 1980s. Their doctor would fill out a form, the FDA would review it, and either give a green light or a red light.
The Right to Try Act removes the FDA from that equation. Under the law, the patient, the doctor, and the drug company can deal directly with each other - no FDA permission required. The argument from supporters was simple: a dying patient should not have to wait for a federal bureaucracy to give them permission to fight for their life.
The catch - and it is a big one - is that the law does not give anyone the right to actually receive a drug. It only gives them the right to ask for one. The drug manufacturer can say no. Insurance companies can refuse to cover it. The patient often pays out of pocket. And if something goes wrong, the law shields nearly everyone involved from being sued.
The full legal name of the law is the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (P.L. 115-176). It is named after four patients with ALS or Duchenne muscular dystrophy who became the public face of the campaign to pass it. The law was championed by the Goldwater Institute, a libertarian think tank based in Arizona that drafted the model legislation states had been adopting since 2014.
How Right to Try Actually Works
The Five-Step Pathway
1
The patient must qualify.They must have a life-threatening disease or condition, must have already exhausted approved treatment options, and must be unable to participate in an active clinical trial for the drug they want to try.
2
The drug must qualify.It must have completed FDA Phase I clinical trials (the earliest stage of human testing, which checks basic safety in a small group of people) and must still be in active development with a registered ongoing trial. Drugs on FDA clinical hold are excluded.
3
The doctor and patient approach the drug maker.The treating physician contacts the manufacturer or sponsor directly. The company can say yes, say no, or ignore the request entirely. They are under no legal obligation to provide the drug, and many decline to do so.
4
The patient signs informed consent and pays.The patient (or their legal representative) signs a written informed consent acknowledging the risks. The patient is generally responsible for the cost of the drug - insurance is not required to cover it, and most do not. Federal law caps what companies can charge to direct costs only, but those costs can still be significant.
5
The manufacturer reports the use to the FDA annually.Drug makers must submit an annual summary to the FDA listing how many patients they treated under Right to Try and what happened. The FDA does not approve or block these requests - its only job is to receive and post the reports.
Plain English Example
The Soft-Launch Restaurant
Imagine a hot new restaurant doing a soft launch before its grand opening. Only invited friends and family are eating there while the kitchen works out the kinks. The health inspector has not signed off yet. The food critic has not reviewed it.
Right to Try is like a city law that says: if you are about to starve, the regular restaurants in town have all failed to feed you, and you cannot get an invite to the soft launch, you are legally allowed to walk up to the back door of the new restaurant and beg for a meal.
That sounds powerful on paper. In practice, four things still have to happen:
1. The restaurant owner has to open the door (the drug maker has to agree). They can slam it shut for any reason.
2. The chef has to actually cook for you (the doctor has to be willing to prescribe).
3. You have to pay full price out of your own pocket (insurance is not required to help).
4. If the food is terrible or makes you sicker, you cannot sue (the law shields the restaurant from liability).
So the law gives you the right to knock. It does not give you the right to eat.
Right to Try is like a city law that says: if you are about to starve, the regular restaurants in town have all failed to feed you, and you cannot get an invite to the soft launch, you are legally allowed to walk up to the back door of the new restaurant and beg for a meal.
That sounds powerful on paper. In practice, four things still have to happen:
1. The restaurant owner has to open the door (the drug maker has to agree). They can slam it shut for any reason.
2. The chef has to actually cook for you (the doctor has to be willing to prescribe).
3. You have to pay full price out of your own pocket (insurance is not required to help).
4. If the food is terrible or makes you sicker, you cannot sue (the law shields the restaurant from liability).
So the law gives you the right to knock. It does not give you the right to eat.
The Case For Right To Try
Why Supporters Pushed For It
- Patient autonomy.A dying adult should be able to make their own informed choices about what to put in their body.
- Bureaucratic bypass.The FDA can be slow even when it eventually says yes. Time matters when you have months to live.
- Liability shields.Doctors, manufacturers, and hospitals are protected from lawsuits when something goes wrong, which removes a major reason companies hesitate to provide drugs.
- Federal floor.Before 2018, the law was a state-by-state patchwork (41 states had their own versions, starting with Colorado in 2014). The federal law makes the rules uniform across the country.
- Bipartisan popularity.The original law passed the Senate by unanimous consent and is consistently popular with voters in both parties.
The Case Against Right To Try
Why Critics Call It Toothless
- The FDA was not the bottleneck.Under Expanded Access, the FDA was already approving roughly 99% of patient requests for experimental drugs, often within days.
- Drug makers usually say no.Companies often prefer the FDA-supervised Expanded Access route, and many decline Right to Try requests outright.
- Phase I means very limited safety data.A drug that has only passed Phase I has been tested on a small group of healthy or moderately-ill volunteers. The risks for desperately sick patients are largely unknown.
- No safety oversight.The FDA cannot use bad outcomes under Right to Try to block or delay approval, which removes a key signal that a drug might be dangerous.
- False hope risk.Critics call it "placebo legislation" - it makes lawmakers feel good and gives families a sense of hope, but very few patients have actually been helped.
- Quack-medicine vulnerability.Stem-cell clinics and other fringe operators have tried to use state Right to Try laws to market unproven treatments.
Case Study
The Numbers Behind a Famous Law
Right to Try has been invoked rarely - much more rarely than the political marketing suggests.
16
Invocations
2018 to 2023
2018 to 2023
12
Products Used
2018 to 2022
2018 to 2022
4
Products Used
In 2023
In 2023
99%
FDA Expanded
Access Approval Rate
Access Approval Rate
The federal Right to Try Act was signed at a White House ceremony in 2018 with great fanfare. President Trump called it "a tremendous thing" that would "save tremendous numbers of lives." The political marketing has not slowed down since - it was a regular line at 2024 campaign events and was invoked again at the 2025 inauguration.
The numbers, though, tell a quieter story. Annual reports submitted to the FDA show that only about 16 individual courses of treatment were administered under the law in its first five years. A total of 12 different products were used between 2018 and 2022, and only 4 products were used in 2023. The exact number of patients is not publicly reported, but credible estimates put it in the hundreds at most.
For comparison, the FDA's much-older Expanded Access program processed roughly 1,952 individual requests in fiscal year 2023 alone (1,318 non-emergency and 634 emergency), and approved about 99% of them. The pathway Right to Try was designed to replace is several orders of magnitude larger and is almost never refused.
The most documented Right to Try patient is Matthew Bellina, the former Navy pilot with ALS whose name is in the title of the law. After it passed, he obtained the experimental drug NurOwn through the new pathway. He died in 2023. A handful of glioblastoma patients have received Gliovac under the law. Therapeutic Solutions International has reported providing stem cell treatments to over 100 patients under Right to Try. Beyond a small set of similar cases, public examples are scarce.
The mismatch between the political volume around Right to Try and its actual usage has become the central critique of the law. Even Scott Gottlieb, who served as Trump's first FDA Commissioner, has pointed out that the agency was already approving the overwhelming majority of expanded access requests before Right to Try existed. The law was solving a problem that, by the numbers, was not actually the bottleneck.
The numbers, though, tell a quieter story. Annual reports submitted to the FDA show that only about 16 individual courses of treatment were administered under the law in its first five years. A total of 12 different products were used between 2018 and 2022, and only 4 products were used in 2023. The exact number of patients is not publicly reported, but credible estimates put it in the hundreds at most.
For comparison, the FDA's much-older Expanded Access program processed roughly 1,952 individual requests in fiscal year 2023 alone (1,318 non-emergency and 634 emergency), and approved about 99% of them. The pathway Right to Try was designed to replace is several orders of magnitude larger and is almost never refused.
The most documented Right to Try patient is Matthew Bellina, the former Navy pilot with ALS whose name is in the title of the law. After it passed, he obtained the experimental drug NurOwn through the new pathway. He died in 2023. A handful of glioblastoma patients have received Gliovac under the law. Therapeutic Solutions International has reported providing stem cell treatments to over 100 patients under Right to Try. Beyond a small set of similar cases, public examples are scarce.
Right to Try vs FDA Expanded Access (Approx. Patients, 2023)
Source: FDA annual reporting summaries and CDER expanded access data.
The mismatch between the political volume around Right to Try and its actual usage has become the central critique of the law. Even Scott Gottlieb, who served as Trump's first FDA Commissioner, has pointed out that the agency was already approving the overwhelming majority of expanded access requests before Right to Try existed. The law was solving a problem that, by the numbers, was not actually the bottleneck.
Right To Try Vs Expanded Access
What Comes Next
How the Two Pathways Compare
Right to Try did not replace the FDA's older Expanded Access program. The two now run in parallel, and most patients who get an experimental drug outside a clinical trial still get it through Expanded Access. Here is how they stack up:
| Feature | Right to Try | Expanded Access |
|---|---|---|
| Year Established | 2018 (federal) | Late 1980s, formalized 1987 |
| FDA Approval Required? | No | Yes |
| FDA Approval Rate | N/A (no review) | About 99% |
| Drug Must Pass Phase I? | Yes, plus active development | No, can be earlier-stage |
| Manufacturer Required to Provide? | No | No |
| Insurance Required to Cover? | No | No |
| Eligible Conditions | Life-threatening only | Life-threatening or serious |
| Liability Protection | Broad shield | Limited |
| Patients in 2023 (est.) | Hundreds (cumulative) | ~1,952 (single year) |
| Safety Data Goes to FDA? | Annual summary only | Per-case IND filing |
Right to Try 2.0
The original 2018 law has limits that the Goldwater Institute is now trying to push past with a follow-up effort called Right to Try 2.0 (or "Right to Try for Individualized Treatments").
The argument behind 2.0 is that medical science has moved on. The newest generation of experimental therapies includes highly individualized treatments - cancer vaccines built from a specific patient's tumor mutations, gene-editing therapies designed for a single ultra-rare genetic disease, custom cell therapies. These treatments cannot meaningfully go through traditional Phase I, II, and III trials, because they are designed for one person.
That creates the catch the Goldwater Institute is targeting: the original Right to Try requires a drug to have passed Phase I, but individualized treatments will essentially never have a Phase I to pass. Right to Try 2.0 removes that requirement for individualized therapies that are tailored to a patient's genetic profile.
As of early 2026, Right to Try 2.0 has passed in at least six states: Arizona, Louisiana, Maryland, Mississippi, Nevada, and North Carolina. New Hampshire's HB 1735, which would do the same thing, is active in the 2026 legislative session. There is no federal Right to Try 2.0 yet, but Trump's second-term policy team has signaled interest in expanding the framework.
Critics, including bioethicists at Wake Forest and elsewhere, argue that loosening the Phase I requirement makes an already thin safety net thinner - and that the only way to make Right to Try genuinely useful would be to add back FDA oversight, which would essentially turn it back into Expanded Access.
The argument behind 2.0 is that medical science has moved on. The newest generation of experimental therapies includes highly individualized treatments - cancer vaccines built from a specific patient's tumor mutations, gene-editing therapies designed for a single ultra-rare genetic disease, custom cell therapies. These treatments cannot meaningfully go through traditional Phase I, II, and III trials, because they are designed for one person.
That creates the catch the Goldwater Institute is targeting: the original Right to Try requires a drug to have passed Phase I, but individualized treatments will essentially never have a Phase I to pass. Right to Try 2.0 removes that requirement for individualized therapies that are tailored to a patient's genetic profile.
As of early 2026, Right to Try 2.0 has passed in at least six states: Arizona, Louisiana, Maryland, Mississippi, Nevada, and North Carolina. New Hampshire's HB 1735, which would do the same thing, is active in the 2026 legislative session. There is no federal Right to Try 2.0 yet, but Trump's second-term policy team has signaled interest in expanding the framework.
Critics, including bioethicists at Wake Forest and elsewhere, argue that loosening the Phase I requirement makes an already thin safety net thinner - and that the only way to make Right to Try genuinely useful would be to add back FDA oversight, which would essentially turn it back into Expanded Access.
The Right to Try Act allows eligible patients to have access to eligible investigational drugs. FDA's role in implementing the Right to Try Act is limited to receiving and posting certain information submitted to the agency.- U.S. Food and Drug Administration, Right to Try guidance page
The Bottom Line
What you actually need to know
Right to Try sounds like a powerful patient-rights law, and politically it is one of the most popular pieces of legislation passed in the last decade. The actual mechanics are narrower than the marketing. The law lets dying patients ask drug makers for unapproved treatments without involving the FDA - but the drug company can still refuse, insurance is not required to pay, and the FDA was already approving 99% of similar requests under the older Expanded Access program. After more than seven years on the books, total documented usage is in the dozens of products and likely the low hundreds of patients. The next chapter is Right to Try 2.0, which would extend the same framework to individualized genetic therapies that genuinely do not fit traditional FDA pathways - that fight is being waged state-by-state through 2026.
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