A search for expanded access help now returns companies offering to manage the process for a fee. Some of that work is real, and none of it produces an investigational product or makes a company hand one over. This guide separates what such services cover from what no service can deliver.
TLDR Expanded access is a federal route to an investigational drug under an active IND held by a willing sponsor, and only a licensed physician can request it. A support service can research, organize, and coordinate. It cannot file for you, cannot force a company to say yes, and cannot obtain a product a clinic sells for cash. Save My Fat provides no such service, and banking adipose tissue guarantees no eligibility, access, or clinical benefit.
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 has FDA approval for any disease. All content is for educational purposes only and does not constitute medical advice. Patients must consult their own licensed healthcare professionals regarding all medical decisions.
When standard options run out, families look for a way to reach a drug that is still in development. Companies have grown up around that search. Before money changes hands, the question is narrow: what does the fee buy?
The pathway itself is federal, set out in Subpart I of 21 CFR Part 312, titled “Expanded Access to Investigational Drugs for Treatment Use.” Our guide to expanded access programs covers the pathway in full.
This route leads to an investigational product under an active IND, not to a product a clinic sells for cash.
What Expanded Access Services Cover
They cover research, paperwork, and coordination around a request that a licensed physician has to make. FDA’s patient page is direct about who asks: “A licensed physician requests the investigational medical product under the expanded access program for you.”
That leaves a defined lane for a third party: looking for an open clinical trial, identifying the sponsor, locating its published policy, gathering records for the physician’s office. None of that work is clinical.
The Expanded Access Navigator is described as a partnership between the Reagan-Udall Foundation for the FDA, patient advocacy organizations, the pharmaceutical industry, and the federal government. Its company directory lists manufacturer policies. It is not an FDA website.
What No Service Can Promise
No service can promise supply, authorization, or access. Two decisions sit outside the control of anyone you hire.
The manufacturer’s agreement comes first, and the manufacturer can refuse. FDA’s information for patients states there is “no law or policy that requires a company to provide access to investigational medical products outside of the clinical trial.” FDA notes that companies may decline for reasons including insufficient supply, and that some use lotteries.
FDA’s own findings are the second gate. Under 312.305(a), FDA must find a serious or immediately life-threatening disease or condition with no comparable or satisfactory alternative therapy, potential benefit that justifies potential risks, and no interference with clinical investigations. For one patient, 312.310 adds that FDA must also find the patient cannot obtain the drug under another IND or protocol.
The Right to Try statute does not remove that veto. No liability attaches to a sponsor, manufacturer, prescriber, dispenser, or other entity for a decision not to provide access, and the Act creates no new entitlement.
Where a Legitimate Service Ends and an Unapproved Offer Begins
The difference is the product. A request under this pathway moves toward an investigational drug a sponsor is developing under an active IND. An unapproved offer is a product for sale, with no IND behind it.
Expanded access always requires an IND or a protocol under an existing IND, with manufacturing and preclinical data in the submission. A sponsor must agree to supply the product and grant FDA a right of reference to its IND. A clinic selling an unapproved product for cash satisfies none of that.
FDA’s language for patients is blunt. Its consumer information page states: “If you are being charged for these products or offered these products outside of a clinical trial, you are likely being deceived and offered a product illegally.” A guide to spotting fake clinics covers the other warning signs.
What a Fee Can and Cannot Be For
Federal cost rules govern the sponsor and the drug, not a third party’s service fee. Under 21 CFR 312.8, “A sponsor must obtain prior written authorization from FDA to charge for an investigational drug,” and “A sponsor may recover only the direct costs of making its investigational drug available.”
One detail gets missed. The added allowance for monitoring, IND reporting, and administrative costs applies only to intermediate-size populations and treatment INDs, not to individual patient requests under 312.310.
Right to Try does not open a market either. It leaves 312.8(d)(1) in force, so cost recovery there is capped at direct costs. It is not a route to buying an experimental product at market price.
Questions to Ask Before You Pay for Help
Ask questions with verifiable answers, each pointing to a document, a decision, or a named person. No answer can promise access.
First, is there an active IND, and has the sponsor agreed to supply the product? Second, where is the company’s published policy, and what does it say? Third, which licensed physician submits the request, and who is accountable? Fourth, what does the fee cover, and is it separate from the sponsor’s authorized cost recovery?
Where Save My Fat Fits, and Where It Does Not
Save My Fat does not provide expanded access services. It does not file these applications, and it cannot obtain an investigational product for anyone.
What it does is narrower. Save My Fat is a connector that links patients and providers with a United States tissue bank. It does not collect, process, store, or treat tissue, and it is not a clinic, a bank, or a medical practice.
Adipose tissue and anything derived from it stays investigational and is not FDA approved for any disease. FDA’s roster of approved cellular therapies lists no adipose-derived product. This science is preliminary and early stage, only a licensed provider can advise an individual, and banking guarantees no eligibility, access, or clinical benefit later.
Frequently Asked Questions
Can anyone guarantee that the company will supply the product?
No. No law or policy requires a company to provide access outside a clinical trial, and companies may decline for reasons including insufficient supply. FDA permission is not the company’s yes.
Is there a public way to check a manufacturer’s policy?
Yes. The Reagan-Udall Navigator lists manufacturer policies in its directory. It is a partnership rather than an FDA website, so confirm the current policy with the company.
Can this pathway get me a stem cell product from a clinic?
No. It leads to an investigational drug under an active IND, and Right to Try requires a completed Phase 1 trial and an active IND, for a drug not approved for any use. FDA’s consumer alert states that no regenerative medicine products are approved for orthopedic conditions, neurological disorders, cardiovascular or pulmonary disease, or chronic pain.
Key Takeaways
Expanded access is a federal route to an investigational drug under an active IND held by a willing sponsor. A support service can research, organize, and coordinate around a physician’s request. It cannot submit in place of that physician, cannot compel a company to say yes, and cannot deliver a product sold outside a clinical trial. Federal cost rules cap a sponsor’s charge at direct costs and say nothing about a third party’s fee, so get scope and refund terms in writing. Save My Fat provides none of these services, and banking adipose tissue guarantees no eligibility, access, or clinical 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.
Readers weighing adipose tissue banking for potential future use can review current pricing or ask a question through the contact page.
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 adipose tissue banking or research participation.
About the author: Oscar Tellez is the founder and CEO of Save My Fat. He holds a Bachelor of Science in Exercise Science and Health Promotion from Florida Atlantic University. He has spent more than a decade in the regenerative medicine industry across product distribution, laboratory and vendor relationships, and provider training. He is not a licensed clinician, and this article is educational, not medical advice.
Related guide: adipose stem cell trials.
