Two federal pathways exist that allow patients with serious conditions to pursue investigational therapies outside of formal clinical trials. One has been around for decades and involves close FDA oversight. The other was created in 2018 to give patients a faster route that bypasses FDA pre-authorization entirely. Understanding how those two pathways work, where they overlap, and where they diverge can make a meaningful difference in the decisions patients and physicians make together.
This guide explains both pathways in plain language, walks through who qualifies, compares the key protections each offers, and addresses what these pathways mean for patients who are following the regenerative medicine research landscape.
TLDR: The Right to Try Act (2018) and the FDA’s Expanded Access Program are both legal pathways for accessing investigational therapies outside clinical trials. The key difference is oversight: Expanded Access involves FDA review and IRB protection; Right to Try does not. Both require manufacturer consent, which is voluntary and cannot be compelled. Understanding the tradeoffs between speed and safeguards is essential before pursuing either pathway.
Important Disclaimer: Save My Fat does not provide FDA-approved treatments or cures for any disease or medical condition. Banking adipose tissue does not create eligibility for the Right to Try Act, the Expanded Access Program, or any investigational therapy. Eligibility for both pathways depends entirely on the specific investigational product, its regulatory status, and the patient’s clinical situation, not on tissue storage. All content here is for educational purposes only and does not constitute medical advice. Patients must consult their own licensed healthcare professionals regarding all medical decisions.
If you have heard about the Right to Try Act, you probably encountered it in a news story about a patient with a terminal diagnosis fighting to access an experimental drug their doctor could not legally prescribe. The law was passed in 2018 with genuine bipartisan support, driven by deeply sympathetic cases, and it generated significant media attention at the time. What got less attention was how it actually works, how frequently it is used, and what patients give up when they choose it over the alternative.
The FDA’s Expanded Access Program, often called compassionate use, has existed for decades and operates under close federal oversight. Right to Try was created partly in reaction to what some advocates saw as the slowness and complexity of that process. The two frameworks now coexist, and patients and physicians sometimes face the question of which one fits their situation better.
That question is worth answering carefully, because the choice has real consequences. The pathways differ in what they require from manufacturers, what oversight they provide for patients, and how adverse events are tracked and reported. This guide walks through both frameworks, compares them directly, and addresses the specific questions that matter most for patients monitoring the regenerative medicine research space. For context on how investigational therapies are studied in clinical trials more broadly, the introduction to clinical trials for regenerative medicine covers that foundation.
What Is the Right to Try Act?
The Right to Try Act was signed into law on May 30, 2018, as Senate Bill 204. Its full official name is the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018, named after patients and advocates who were central to the effort to pass it. The law is codified at 21 U.S.C. Section 360bbb-0a. Its text is publicly available through Congress.gov.
The core purpose of the law is to create a pathway for patients with life-threatening conditions to access investigational drugs, biological products, or devices directly from manufacturers, without requiring prior FDA authorization, provided a defined set of criteria are met. The FDA’s own Right to Try overview page and the FDA Right to Try Fact Sheet are the authoritative sources on how the law operates in practice.
What the Right to Try Act Does and Does Not Do
Right to Try does several things that are genuinely significant. It creates a federal legal framework allowing manufacturers to provide investigational products to eligible patients without submitting a separate FDA application for each use. It limits FDA’s ability to use information from RTT use against manufacturers in future marketing applications. It provides some liability protection for manufacturers and physicians who participate in good faith.
What Right to Try does not do is equally important to understand. It does not require any manufacturer to provide their product to any patient. Participation by manufacturers is entirely voluntary and cannot be compelled by patients, physicians, or courts. It does not guarantee that an eligible patient will receive the product. It does not provide FDA or IRB oversight during the use, which means the external safeguards present under Expanded Access are not present under RTT. It does not require mandatory reporting of adverse events to the FDA, though voluntary reporting is possible. The law created a legal pathway, not an entitlement.
What Is the FDA Expanded Access Program?
The FDA’s Expanded Access Program (EAP), also referred to as compassionate use, is a decades-old regulatory framework that allows patients with serious or immediately life-threatening conditions to access investigational products outside of clinical trials when no comparable approved alternative exists. The full FDA overview is available at the FDA Expanded Access page, with additional guidance for physicians at the FDA Expanded Access Information for Physicians page.
Expanded Access operates under FDA oversight at every stage. A physician submits a request, the manufacturer provides a letter of authorization, the FDA reviews and authorizes (or declines) the request, and an Institutional Review Board (IRB) provides ethics oversight except in emergency situations where that review can occur after the fact. The FDA has consistently authorized approximately 99 percent of properly completed individual patient requests, typically within days.
For patients researching this pathway, the Save My Fat guide to expanded access programs provides a detailed walkthrough of the process and what patients should realistically expect.
The Three Types of Expanded Access
Expanded Access is not a single process. It has three distinct tracks designed for different circumstances:
Individual Patient EAP is the most common form. A physician submits Form FDA 3926 on behalf of a single patient who has a serious or immediately life-threatening condition, has no comparable alternatives, and cannot enroll in a clinical trial. The FDA reviews the request, and most are authorized quickly.
Intermediate-Size Patient Population EAP applies when a physician wants to treat a small group of patients (more than one but fewer than needed for a formal trial) with the same investigational product under the same protocol. This requires more documentation and a more developed protocol.
Treatment IND or Treatment Protocol is the largest-scale EAP track, intended to make a promising investigational product more widely available before formal approval when enough evidence of potential benefit has accumulated and the sponsor agrees to provide it.
Right to Try vs. Expanded Access: The Key Differences
Understanding the structural differences between the two frameworks is the most important thing a patient can do before deciding which pathway to pursue with their physician. The table below organizes those differences across the factors that matter most to patients.
The two pathways share a core requirement: manufacturer participation is voluntary in both cases. No patient, physician, or court can compel a manufacturer to provide an investigational product under either framework. The differences emerge in everything else, particularly the level of oversight provided.
| Factor | Expanded Access (EAP) | Right to Try (RTT) |
|---|---|---|
| FDA Involvement | FDA reviews and authorizes each request | No prior FDA authorization required |
| IRB Review | Required (except emergencies) | Not required by law |
| Product Eligibility | Must be under an active IND | Must have completed Phase I, not FDA-approved, under active development |
| Patient Eligibility | Serious or life-threatening condition, no alternatives, cannot enroll in trial | Life-threatening condition, exhausted approved options, cannot enroll in trial |
| Manufacturer Participation | Voluntary | Voluntary |
| Informed Consent | Required, IRB-reviewed | Required, between physician and patient |
| Adverse Event Reporting | Mandatory to FDA and manufacturer | Not mandated by law; voluntary submission possible |
| Physician Responsibility | Shared with FDA and IRB oversight | Assumed primarily by the treating physician |
| Patient Safeguards | Higher, FDA and IRB both monitor | Lower, fewer external protections |
What this means in plain language is that Expanded Access wraps the patient experience in a layer of institutional review and federal oversight that Right to Try deliberately removes. Under RTT, the physician and patient make decisions with less external accountability, which can mean faster access but also means that if something goes wrong, there is less mandatory infrastructure for documenting and responding to it. Neither framework promises an outcome. Both require that patients understand the investigational nature of what they are pursuing.
Who Qualifies for Right to Try?
The RTT Act defines eligibility criteria for both the patient and the product. Both sets of criteria must be met simultaneously, and meeting one does not guarantee the other.
Patient eligibility criteria under the Right to Try Act:
- A diagnosis of a life-threatening disease or condition (defined by 21 CFR 312.81 as a disease with a high probability of causing death if the disease follows its natural course)
- Having exhausted all FDA-approved treatment options
- Being unable to participate in a clinical trial involving the product in question
- Having provided written informed consent acknowledging the investigational nature of the product
Product eligibility criteria under the Right to Try Act:
- The product must have completed at least one Phase I clinical trial in humans (meaning early safety data exists)
- The product must not be FDA-approved for any indication
- The product must be under active clinical investigation, meaning not discontinued and not currently on clinical hold
- The product must be the subject of an ongoing clinical development program intended to eventually support FDA marketing approval
This second set of criteria is where many products being marketed in the regenerative medicine space fail to qualify. A product that is being sold at a clinic but has not completed a registered Phase I trial and does not have an active IND is not eligible for Right to Try, regardless of what the clinic claims. For context on what Phase I completion actually means and requires, the clinical trial phases framework is relevant here.
One additional regulatory consideration applies to certain adipose-derived products: enzymatically processed stromal vascular fraction (SVF) is generally classified by the FDA as more than minimally manipulated under 21 CFR Part 1271, placing it under the Section 351 biologic pathway rather than the Section 361 HCT/P pathway. This means such products typically require both an active IND and Phase I completion to qualify for RTT. The Save My Fat guide to FDA regulations for adipose tissue covers this regulatory framework in more depth.
Who Qualifies for Expanded Access?
The FDA uses five primary criteria to evaluate EAP eligibility for individual patients. These criteria come directly from FDA guidance and are applied when a physician submits a request:
- The patient has a serious or immediately life-threatening condition
- There is no comparable or satisfactory alternative therapy available
- The potential benefit to the patient justifies the potential risks of the investigational product
- The potential risks are not unreasonable in the context of the disease
- Providing the product will not interfere with the initiation, conduct, or completion of clinical trials
How the EAP Application Process Works
The process for individual patient Expanded Access follows a defined sequence. First, the treating physician identifies the specific investigational product and contacts the manufacturer to request a letter of authorization (LOA). Without the manufacturer’s agreement to provide the product, the process cannot proceed. If the manufacturer agrees, the physician submits Form FDA 3926 to the FDA. For most individual patient requests, the FDA responds within days, and emergency requests can receive a response within 24 hours. An IRB must also review and authorize the use, though in life-threatening emergency situations this review can occur after the fact. Informed consent is required throughout.
The Reagan-Udall Foundation’s Expanded Access Navigator is a free, practical tool for patients and physicians navigating this process. It helps identify whether a specific investigational product has an existing expanded access program, provides contact information for sponsors, and walks through the application process step by step.
Common Questions About Right to Try and Regenerative Medicine
This section addresses the questions most relevant to patients who are researching adipose-derived therapies and considering the role that tissue banking might play in their long-range planning.
Does banking adipose tissue create Right to Try eligibility?
No. Tissue banking and RTT eligibility are entirely separate. Storing adipose tissue through a service like Save My Fat preserves biological material for potential future use in FDA-regulated pathways. Whether a patient qualifies for Right to Try depends on their diagnosis, whether they have exhausted approved treatments, their inability to enroll in a clinical trial, and whether the specific product they are seeking has completed Phase I and is under active development. None of those criteria are affected by whether or where tissue is banked.
Are adipose-derived products eligible for Right to Try?
Some may be, but most currently are not, for a straightforward reason: the RTT product criteria require completed Phase I human safety trials and an active development program under an IND. Many ADSC-based products being investigated are currently in Phase I or Phase II, and the timeline from there to the RTT eligibility threshold varies by product and sponsor. A patient interested in whether a specific product qualifies would need to work with a physician to verify the product’s current regulatory status, its IND status, and whether its development program is ongoing. For context on what the emerging research landscape looks like for adipose-derived therapies, the Save My Fat emerging research section provides an overview.
What about Florida’s state-level Right to Try expansion?
In 2025, Florida enacted SB 1768, which explicitly references regenerative therapies derived from placental, umbilical, or perinatal tissues processed in FDA-registered facilities under GMP standards. This state-level development is worth noting for patients in Florida who may be researching perinatal tissue products specifically. State Right to Try laws have different scopes and criteria than the federal law. The bill text is publicly available at flsenate.gov. State laws do not override federal FDA jurisdiction, but they can affect how manufacturers and physicians operate at the state level.
What about the standard for “life-threatening” under RTT?
This is more restrictive than it might sound. “Life-threatening” under federal Right to Try follows the definition in 21 CFR 312.81, meaning a disease with a high probability of causing death if it runs its natural course. Chronic conditions that are debilitating but not immediately life-threatening, many musculoskeletal conditions, and wellness-oriented applications do not qualify under this standard. Expanded Access uses a somewhat broader standard of “serious or immediately life-threatening,” which in practice includes more conditions.
Which Pathway Is Right for Patients?
This is a question only a physician can answer for any individual patient, and this guide is not in a position to recommend one pathway over the other in general terms. What it can do is lay out the considerations that physicians and patients should weigh together.
Expanded Access provides more regulatory infrastructure. The FDA reviews each request, an IRB provides ethics oversight, adverse events are tracked and reported, and the external accountability creates a record that can inform future research. The process takes days in most individual patient cases, not months, and the FDA authorizes the overwhelming majority of properly submitted requests. For most patients who are candidates for either pathway, the EAP process is the more established route.
Right to Try offers speed and removes the FDA authorization step, which was the primary policy goal of the law. In exchange, the patient and physician operate with fewer external safeguards. Adverse events are not mandatorily reported to the FDA, IRB oversight is absent, and the accountability framework shifts significantly onto the treating physician. Whether that tradeoff is appropriate depends on the patient’s clinical situation, the nature of the product in question, and the physician’s judgment about risk.
In practice, RTT has been used far less frequently than the Expanded Access Program since it was enacted in 2018. This is partly because EAP has a proven track record, partly because many manufacturers prefer the documented oversight structure of EAP, and partly because the FDA’s quick turnaround on individual patient requests diminishes the speed advantage RTT would otherwise offer.
The Reagan-Udall Expanded Access Navigator is an excellent starting point for patients and physicians exploring either pathway. It provides a structured tool for identifying programs, locating manufacturer contacts, and understanding what each pathway requires.
Frequently Asked Questions
What is the Right to Try Act and when was it passed?
The Right to Try Act is a federal law signed on May 30, 2018, that creates a pathway for patients with life-threatening conditions to access certain investigational products directly from manufacturers without prior FDA authorization. It is formally named after five patients and advocates who were central to the effort to pass it and is codified at 21 U.S.C. Section 360bbb-0a. The law operates independently of the FDA’s Expanded Access Program and imposes different eligibility criteria, different oversight requirements, and different adverse event reporting obligations. It does not guarantee that any patient will receive any product.
How is Right to Try different from Expanded Access?
The primary difference is oversight and process. Expanded Access requires FDA review and authorization for each request, IRB ethics review, and mandatory adverse event reporting. Right to Try removes all three of those requirements, allowing a patient and physician to pursue an investigational product without submitting anything to the FDA in advance. Both pathways require manufacturer consent, which is voluntary in both cases. Expanded Access has a longer track record, more FDA data to support its outcomes, and is used far more frequently than Right to Try.
Who qualifies for Right to Try?
Patients must have a life-threatening disease, have exhausted all FDA-approved treatment options, be unable to enroll in a clinical trial involving the product, and provide written informed consent. The product being sought must have completed at least one Phase I clinical trial, not be FDA-approved for any indication, be under active IND-supported development, and not be on clinical hold. Meeting both the patient and product criteria simultaneously is required.
Does Right to Try require FDA approval?
No. Right to Try specifically removes the requirement for prior FDA authorization, which is its defining feature compared to Expanded Access. However, the product being pursued must already have completed Phase I human trials under an active IND, meaning it is not a completely unregulated product. The absence of FDA pre-authorization means there is no FDA review of the specific use, no FDA oversight during the use, and no mandatory reporting of results back to the FDA.
Does the manufacturer have to say yes under Right to Try?
No. Manufacturer participation is entirely voluntary under both Right to Try and Expanded Access. A manufacturer can decline to provide their investigational product to any patient under either pathway without legal consequence. This is one of the most frequently misunderstood aspects of RTT: the law created the right to ask, not the right to receive. Patients who are pursuing either pathway should plan for the possibility that the manufacturer may decline.
What products qualify under Right to Try?
Any drug, biologic, or device that has completed at least one Phase I trial, is not FDA-approved for any indication, is under an active IND-supported development program intended to support future FDA approval, and is not on clinical hold or discontinued. Products that are being sold at clinics without Phase I completion or active IND status do not qualify.
Is Right to Try available for regenerative medicine or adipose-derived therapies?
It depends entirely on the specific product. For an ADSC-based product to qualify, it would need to have completed Phase I trials, have an active IND, and be under ongoing clinical development. Many ADSC products being studied are still in Phase I or Phase II, meaning they may eventually qualify if their development programs continue. Products being marketed at clinics without registered Phase I trial completion and without an active IND do not meet the RTT product criteria, regardless of marketing claims. For background on what the adipose-derived stem cell research landscape looks like, the patient guide to ADSCs covers the current state of that science.
What are the risks of using Right to Try instead of Expanded Access?
The primary risk is reduced institutional oversight. Under RTT, there is no FDA review of the specific use, no mandatory IRB oversight, and no required adverse event reporting to the FDA. This means that if something goes wrong, there is no external mechanism automatically tracking it or feeding that information back into the broader research system. The treating physician assumes a greater share of the responsibility for monitoring and managing the patient’s experience. For some patients and physicians, the reduced speed advantage of RTT (given how quickly the FDA authorizes EAP requests) may not justify taking on that additional accountability.
Does banking tissue with Save My Fat connect me to Right to Try?
No. These are entirely separate processes. Save My Fat provides adipose tissue banking and cryopreservation services that preserve a patient’s own tissue for potential future use in FDA-regulated pathways. Whether a patient qualifies for Right to Try is determined by their diagnosis, treatment history, trial enrollment status, and the specific investigational product’s regulatory status. None of those criteria are affected by whether or where tissue is banked. For information on what adipose tissue banking involves and what it preserves, the complete tissue banking guide covers the process in detail.
Which pathway is better for patients, Right to Try or Expanded Access?
Neither pathway is categorically better. The answer depends on the patient’s clinical situation, the product in question, and what the treating physician recommends. Expanded Access provides more regulatory safeguards and a documented track record. Right to Try offers a faster route with less administrative process but fewer external protections. In practice, the FDA’s quick authorization of most properly submitted EAP individual patient requests has reduced the speed advantage that RTT was designed to provide. Patients should not choose between these pathways based on marketing from any clinic or company; that decision belongs in a conversation with a knowledgeable physician.
Key Takeaways
- Two pathways, different oversight structures. Right to Try removes FDA pre-authorization and IRB review. Expanded Access requires both, and both are meaningful patient protections.
- Manufacturer consent is voluntary in both cases. No law compels a manufacturer to provide their investigational product to any patient under either framework.
- Product eligibility under RTT is specific. The product must have completed at least one Phase I trial, be under an active IND, and be in ongoing clinical development. Most products marketed at clinics do not meet these criteria.
- EAP has a strong track record. The FDA authorizes the vast majority of properly submitted individual patient requests, typically within days, which diminishes the speed advantage RTT was designed to offer.
- Reduced oversight means reduced accountability. Under RTT, adverse events are not mandatorily reported to the FDA. The treating physician assumes more responsibility for monitoring and managing outcomes.
- Banking tissue does not create access. Tissue banking preserves biological material for potential future use. It does not establish RTT eligibility, EAP eligibility, or eligibility for any specific investigational product.
- State laws add complexity. States like Florida have enacted their own Right to Try expansions with different scope and criteria. These operate alongside, not in place of, federal law and FDA jurisdiction.
- Physician guidance is irreplaceable. The decision between RTT, EAP, clinical trial enrollment, or continuing with approved therapies is one that requires a knowledgeable physician who understands both the patient’s clinical situation and the specific product’s regulatory history.
Learn More
Understanding the regulatory pathways available for investigational therapies is one part of making informed long-range health decisions. For patients who are following the regenerative medicine research landscape and thinking about what it means for their own planning, the following resources on this site provide useful context.
Save My Fat helps individuals preserve their own adipose tissue through validated cryopreservation protocols for potential future opportunities that may arise as regenerative medicine science and FDA regulations evolve. Banking tissue does not guarantee eligibility, access, or clinical benefit from any future therapy or investigational pathway. Save My Fat does not provide FDA-approved treatments or cures.
For information on the tissue banking process itself, see how stem cell banking works. For patients exploring their options, the patients section provides an overview of what Save My Fat offers. For providers interested in offering tissue banking to their patients, the providers section covers how that relationship works. To learn more about the company, visit the about us page.
The Reagan-Udall Expanded Access Navigator is a free resource for patients and physicians navigating the Expanded Access process and is not affiliated with Save My Fat.
Visit savemyfat.com to learn more.
This article is for educational purposes only and does not constitute medical advice. Please consult your licensed healthcare provider regarding all medical decisions.
Last Updated: April 4, 2026
