Right to Try: how it works and where it is recognized

Last reviewed 2026-05-16 by Reserve Meds clinical and regulatory team.

What Right to Try is

Origin and authorising body. United States, the federal Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018, plus parallel state-level Right to Try laws. The authorising body for each individual case is the no federal pre-authorisation; manufacturer and treating physician operate directly, with FDA notification requirements at the manufacturer level, acting under that jurisdiction's pharmacy or medicines legislation.

Case active and ready to skip the regulatory walkthrough? Start your case or WhatsApp us.

Legal basis. The federal Right to Try Act (Public Law 115-176, signed 30 May 2018) authorises terminally ill patients to seek investigational treatments from manufacturers without going through the FDA's expanded-access programme. The Act requires the patient to have a life-threatening illness, exhaust approved treatment options, have been unable to participate in a clinical trial, provide written informed consent, and receive a treating physician's certification.

Right to Try is a US federal framework that operates parallel to FDA Expanded Access. It removes the FDA pre-authorisation requirement but retains manufacturer agreement (the manufacturer is not obligated to provide the medicine), treating physician certification, and informed consent. The framework has been less frequently used than Expanded Access because most manufacturers prefer the structured FDA Expanded Access framework, which provides clearer liability protection and adverse-event reporting structure.

The Right to Try Act requires the investigational drug to have completed a Phase 1 clinical trial and to be the subject of an active IND. The Act limits manufacturer liability for outcomes arising from Right to Try supply. Some states have additional Right to Try laws that pre-date the federal Act; these are largely subsumed by the federal framework but may add state-level operational requirements. The framework is US-only and does not provide cross-border access in its own right.

This page consolidates Reserve Meds's operational view of the Right to Try (US) framework across the ten destination countries where we currently coordinate cross-border supply. Earlier in our content build we maintained separate per-country sub-pages for each Right to Try (US)-in-country combination; those sub-pages remain available for archival reference but are no longer separately indexed, and the operational intelligence they carried has been folded into the country-compatibility table below.

Reserved for you.

Who can use Right to Try

Right to Try is used by US terminally ill patients on the certification of a US-licensed treating physician. The framework is US-only; cross-border patients cannot use Right to Try directly. International precedents for similar frameworks exist in several jurisdictions (Italy's Stamina-like protocols, Germany's Section 79 emergency authorisation) but operate under distinct legal architectures.

In practical terms, a Reserve Meds case opens when the treating physician has identified the clinical need, has reached a decision to prescribe a specific medicine, and has determined that the locally available route is unsuitable or unavailable. We then layer the regulatory and supply-chain coordination on top of that clinical decision; we do not originate the prescribing question and we do not advise on the clinical choice. The decision sits with the physician throughout.

Drug categories typically covered under Right to Try

Investigational oncology agents in late-Phase development for terminally ill patients, investigational rare-disease therapies, and investigational antivirals for terminal infections.

The medicine itself must be source-country approved or in active regulatory development under a recognised reference authority (typically the US FDA, the European Medicines Agency, the UK MHRA, the Japan PMDA, or Health Canada). Most destination regulators will not authorise a Right to Try (US) import for a medicine that lacks a recognised reference authorisation anywhere in the world, because the regulator's risk assessment leans on the source-country review as a substitute for its own.

Country compatibility

The table below summarises how the Right to Try (US) framework is recognised across the ten destination countries where Reserve Meds currently coordinates cross-border supply. The "Accepts Right to Try (US) dossiers" column reflects whether the destination regulator typically reviews and grants permits on the strength of a Right to Try (US) clinical justification packet, or whether the patient must use a different parallel framework on the receiving side. Timelines reflect routine cases with a complete documentation set; first-import scenarios, paediatric weight-banded presentations, advanced therapy medicinal products, and large multi-cycle quantities can extend the regulator review by several weeks.

Notes. "Indirect" means the destination regulator does not directly accept Right to Try (US) authorisation as the legal basis for import but does recognise a Right to Try (US) authorisation as supporting precedent within its own named-patient or compassionate-use review. "Not applicable" means the framework is not a patient-access pathway in the cross-border sense and is shown here for completeness. Regulator names: NHRA (Bahrain), EDA (Egypt), CDSCO (India), JFDA (Jordan), KDFC (Kuwait), MoPH (Lebanon), MoH-DGPADC (Oman), MoPH-DPA (Qatar), SFDA (Saudi Arabia), and EDE (United Arab Emirates, federal from 29 December 2025).

Documentation required

A Right to Try application is typically assembled in coordination with the treating physician, the dispensing facility, and the cross-border supply partner. The documentation set below covers the routine case; specific destination countries may require additional items (most frequently a hospital ethics committee notification for paediatric or complex cases, and an insurer pre-authorisation letter where the patient intends to seek reimbursement).

• Treating physician's certification that the patient has a life-threatening illness and has exhausted approved options.
• Patient's written informed consent.
• Manufacturer agreement to supply the investigational drug.
• FDA notification (the manufacturer reports annual safety data to the FDA).
• Documented Phase 1 completion and active IND for the drug.

Typical timeline

Right to Try removes the FDA review timeline. Timelines depend on manufacturer agreement and clinical readiness; some cases proceed within days, others take weeks. Cross-border patients use parallel frameworks (typically 4 to 8 weeks end-to-end).

Costs and reimbursement

Manufacturers may charge cost-recovery prices under Right to Try. Some provide medicines free; some charge. Insurer reimbursement is uncommon.

Where Reserve Meds fits in

Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine access. For Right to Try (US) cases, we coordinate the US-side sourcing through a DSCSA-compliant specialty channel, prepare the documentation packet your physician submits, coordinate validated cold-chain logistics with continuous temperature logging into the destination country, and assign a single named coordinator through the case. We do not replace your treating physician, we do not replace the destination-country regulator, and we do not replace your dispensing pharmacy. We coordinate the supply side so the physician can focus on patient care.

For each of the ten destination countries above, we publish a country-specific page documenting the operational realities (which dispensing facilities handle named-patient cases, how the cold chain is verified at the local airport, how the dispensing pharmacy releases the medicine, and what the typical insurer interaction looks like). Those country pages, combined with this pathway page and the specific drug pages, give the prescribing physician and the patient a coherent picture of what to expect before any commitment is made.

Our concierge fee is itemised separately on every firm quote alongside the drug acquisition cost, international logistics, customs, and dispensing pharmacy handling. The patient sees the full breakdown before deciding to proceed; we do not bundle costs and we do not charge an intake deposit. If the case cannot proceed for regulatory or supply reasons, we say so before any payment is taken.

Next step

If your treating physician has identified a clinical need that fits the Right to Try (US) framework and you are weighing the cross-border route, the next step is a short intake. We confirm eligibility within 24 to 48 hours and send a documentation kit to your physician.

Start your caseWhatsApp

Reserved for you.

---

Related

• All access pathways
• UAE access landscape
• Saudi Arabia: SFDA named-patient pathway
• When conventional access fails
• How Reserve Meds works