Since the federal Right to Try Act was signed in 2018, the two pathways for reaching investigational therapies outside a clinical trial, Right to Try and expanded access, have often been treated as interchangeable. They are not. They differ in legal basis, FDA involvement, IRB requirements, eligibility standards, and the protections each affords, and those differences matter when the therapy in question is an investigational cell therapy. What follows is a clear comparison and a practical guide to which pathway fits which patient scenario.
TLDR: Expanded access (21 CFR Part 312, Subpart I) requires FDA authorization via Form 3926, IRB review, and sponsor cooperation, with active FDA oversight. Right to Try (21 U.S.C. 360bbb-0a, 2018) lets eligible patients request investigational products directly from manufacturers without FDA pre-authorization or IRB review, but the manufacturer is not obligated to supply, and eligibility is narrower (life-threatening disease, exhausted approved options, unable to enroll in a trial). For most early-stage adipose cell therapies, expanded access is the more realistic route. Banking adipose tissue does not enroll a patient in therapy and does not guarantee any eligibility, access, or benefit under either pathway.
Important Disclaimer: Save My Fat does not provide FDA-approved treatments or cures for any disease. Banking adipose tissue today does not guarantee eligibility, access, or clinical benefit from any future therapy, clinical trial, or medical program. No adipose-derived stem cell product currently holds FDA approval for the conditions discussed in this article. All content is for educational purposes only and does not constitute medical or legal advice. Patients must consult their own licensed healthcare professionals regarding all medical decisions.
The distinction is not academic. A physician who conflates the two pathways can give a patient an inaccurate picture of what is achievable, who decides, and what protections apply. Knowing the differences makes the conversation more complete and more credible, and it is the necessary groundwork before contacting a patient, a sponsor, or FDA about either route.
Why the Distinction Matters in the Cell Therapy Context
Both pathways exist to help seriously ill patients reach investigational products, but they were built differently and carry different obligations. They have distinct eligibility requirements, different levels of FDA involvement, different manufacturer obligations, and meaningfully different applicability in practice to biologics and cell therapies. For a physician considering either route for a patient seeking an investigational adipose MSC therapy, understanding the distinction is a prerequisite, not a detail to sort out later.
Expanded Access in Brief
Expanded access operates under 21 CFR Part 312, Subpart I. It requires FDA authorization, through Form 3926 for a single-patient IND, IRB review and authorization, and the sponsor’s cooperation in supplying the product. FDA is actively involved: it reviews the application, can place it on clinical hold, and requires ongoing reporting. The full step-by-step process is covered in the companion guide to the expanded access programs framework. The structure is more demanding than Right to Try, but that structure is also what provides documentation and oversight.
What the Right to Try Act Actually Provides
The federal Right to Try Act, codified at 21 U.S.C. 360bbb-0a and signed in May 2018, allows an eligible patient to request access to an investigational drug or biologic directly from the manufacturer without FDA pre-authorization. Eligibility is specific: the patient must have a life-threatening disease or condition, have exhausted approved treatment options, be unable to participate in a clinical trial of the product, and have a physician’s written certification that these criteria are met. The product must be under an active IND or otherwise in active development as the statute specifies. Two features distinguish it sharply from expanded access. No FDA pre-authorization is required, the manufacturer and physician proceed without an FDA application, and IRB review is not required. But a crucial limit applies: the manufacturer is not obligated to provide the product. Right to Try is a patient’s right to ask, not a manufacturer’s duty to supply.
The Critical Differences
| Factor | Right to Try | Expanded Access |
|---|---|---|
| Legal basis | 21 U.S.C. 360bbb-0a (2018) | 21 CFR Part 312, Subpart I |
| FDA pre-authorization | Not required | Required (Form 3926 for single-patient IND) |
| IRB review | Not required | Required |
| Patient eligibility | Life-threatening disease; exhausted approved options; cannot enroll in a trial | Serious or life-threatening disease; no comparable alternative; benefit justifies risk |
| Manufacturer obligation to supply | None; may decline | None, though FDA encourages participation |
| FDA involvement during treatment | Minimal | Active: reviews, can hold, requires reporting |
| Applies to biologics/cell therapies | Yes, if product is under active IND | Yes, if product is under active IND |
| Applies to devices | No | Yes (via the IDE pathway) |
| Cost to patient | Manufacturer may charge | Cost permitted; manufacturer may provide at no charge |
| Liability framing | Statute includes limited liability provisions | No special liability protection beyond standard practice |
| State-law overlay | Many states have their own Right to Try laws | Federal only |
Which Pathway Is Realistic for Adipose MSC Therapies
For most investigational adipose cell therapies, expanded access is the more realistic route, for a few reasons. Most adipose programs are early-stage, Phase 1 or 2, and a manufacturer at that stage, still collecting safety data, is generally reluctant to supply a product through Right to Try, where FDA oversight and IRB review are absent. The structured FDA involvement in expanded access gives both physician and patient clearer documentation and protections that are appropriate for an early-stage product. Counterintuitively, Right to Try’s lighter oversight can make some manufacturers less willing to participate, not more, because they bear more of the risk without the FDA framework around them. Right to Try is more plausible when a product has completed Phase 3 and has extensive safety data, the manufacturer maintains a dedicated Right to Try program, and the patient clearly meets the life-threatening and exhausted-options criteria.
Pathway Selection Guide
| Patient scenario | Reasonable pathway | Reasoning |
|---|---|---|
| Life-threatening condition; investigational adipose product in a Phase 2 trial; sponsor runs an expanded-access program | Expanded access | Structured oversight suits an early-stage product |
| All approved options exhausted; manufacturer has completed Phase 3 and runs a dedicated Right to Try program | Right to Try | The scenario the statute was designed for |
| Patient does not meet Right to Try eligibility (not life-threatening, or approved alternatives exist) | Expanded access | Right to Try unavailable; expanded access has broader eligibility |
| Patient wants to bank autologous tissue for possible future autologous use | Bank now; choose the pathway when therapy is actually needed | Banking is the upstream step; pathway choice comes later |
What Physicians Document Either Way
Both pathways share core documentation. The physician’s written certification of eligibility is required under Right to Try and advisable under expanded access. Written informed consent is needed in both. A monitoring plan should be in place. Adverse events must be handled, though the reporting requirements differ by pathway. And for any autologous therapy, chain-of-custody documentation for the banked tissue, from harvest through administration, is essential regardless of which pathway is used.
Frequently Asked Questions
Does Right to Try mean a manufacturer must provide the therapy?
No. Right to Try gives an eligible patient the right to request a product directly from the manufacturer, but the manufacturer is not obligated to supply it and may decline.
Which pathway requires IRB review?
Expanded access requires IRB review and authorization. Right to Try does not require IRB review, which is one of the central differences between the two.
For an early-stage adipose cell therapy, which pathway is more realistic?
Usually expanded access. Manufacturers of early-phase products are generally more comfortable with the FDA-overseen, IRB-reviewed structure of expanded access than with the lighter-oversight Right to Try route.
Key Takeaways
Right to Try and expanded access are not interchangeable. Expanded access runs through FDA with Form 3926, requires IRB review and sponsor cooperation, and carries active agency oversight. Right to Try skips FDA pre-authorization and IRB review and lets a patient request a product directly from a manufacturer, but the manufacturer can decline, and eligibility is narrower. For the early-stage adipose cell therapies that dominate the current pipeline, expanded access is generally the more realistic route, while Right to Try fits better for products with extensive Phase 3 safety data and a dedicated manufacturer program. Whichever applies, the documentation overlaps, and for autologous therapy, banked-tissue chain of custody is essential. Banking itself remains a preservation decision separate from therapy, opening neither pathway automatically and guaranteeing neither access nor benefit.
Save My Fat operates as a tissue preservation service, not a medical practice or treatment provider. Stem cell and regenerative medicine regulations vary by state, including specific informed-consent and disclosure requirements in Florida, Utah, and Nevada governing tissue and stem cell services. Banking adipose tissue does not connect patients to any treatment pathway, and any future use depends on FDA regulatory status, physician guidance, and the availability of approved or investigational pathways at that time.
Physicians weighing these pathways for a patient with banked tissue can contact Save My Fat to discuss the preservation side.
Save My Fat partners with L2 Bio for laboratory processing and storage.
This article is for educational purposes only and does not constitute medical or legal advice. Legal and medical review including neurology and neurosurgery input is required before publication. Please consult your neurologist or neurosurgeon before making any decisions about neurologic treatment or research participation.
