The Federal Right to Try Act, Explained

For a patient who has run out of approved options, the idea behind “right to try” is powerful: a chance to access an experimental drug that is not yet on the market. The federal Right to Try Act, signed into law on May 30, 2018, created a pathway to do exactly that. But the law is narrower, and comes with more caveats, than its name suggests.

What the law actually does

The Right to Try Act (its full name honors patients Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina) lets eligible patients seek investigational drugs directly from the manufacturer, without going through the FDA’s expanded-access review. The theory is to cut paperwork and delay for people who may not have time to wait.

Who qualifies

The federal law sets specific conditions. A patient must:

• Have a life-threatening disease or condition.
• Have exhausted approved treatment options and be unable to participate in a clinical trial of the drug.
• Seek a drug that has completed a Phase 1 trial and remains in active development (it is not yet FDA-approved).
• Get their treating physician’s certification that they meet the criteria.
• Provide written informed consent.

The limits that surprise people

This is the crucial part. Right to Try grants permission to ask; it does not guarantee access. The law does not:

• Require the drug manufacturer to provide the medication, they can say no, and often do.
• Require insurers to pay for it. Manufacturers are allowed to charge the direct costs.
• Require any physician to prescribe it.
• Guarantee the drug is safe or effective. A Phase 1 trial only checks basic safety and dosing, not whether the drug works.

By bypassing the FDA and institutional review boards, the law also removes a layer of oversight that some patient advocates consider a protection rather than an obstacle.

The practical reality

In practice, Right to Try has been used far less than expected. Most patients seeking pre-approval drugs still go through the FDA’s expanded access program, which approves the large majority of requests, often within days. Many states also passed their own right-to-try laws before the federal one, but the federal Act now provides a nationwide framework. If you are considering this route, the first step is a candid conversation with your specialist about clinical trials, expanded access, and whether the manufacturer is even willing to provide the drug.

This is general information, not legal or medical advice. For your situation, talk with your treating physician and, if needed, a health-care attorney.