Section 4 of 10 — Federal law

The Federal Right to Try Act (2018)

Public Law 115-176 — a narrow federal pathway for terminally ill patients to access investigational drugs that have completed Phase 1 trials and remain under an active FDA Investigational New Drug (IND) application. It is not a general license to use any unapproved product, and it has no connection to any state law, clinic brand, or political figure.

Educational information only — not medical or legal advice. This page is for general public education about FDA regulation of regenerative medicine. It does not diagnose, treat, or recommend treatment for any condition, and it is not a substitute for consulting a licensed physician about a medical question or a licensed attorney about a legal question. See the full disclaimer.

What the Act is

Official short title	Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017
Public Law	Pub. L. 115-176
Signed	May 30, 2018
Codification	21 U.S.C. § 360bbb-0a (new FD&C Act § 561B)
Scope	Federal law of nationwide application

This is a federal law. It is unrelated to any state-branded program and is not associated with any particular company or clinic.

Who qualifies as an "eligible patient"

Per 21 U.S.C. § 360bbb-0a(a)(1), a patient must: (A) have been diagnosed with a life-threatening disease or condition as defined at 21 CFR § 312.81; (B) have exhausted approved treatment options and be unable to participate in a clinical trial involving the investigational drug, as certified by a physician who is in good standing and not directly compensated by the manufacturer for that certification; and (C) provide written informed consent.

What qualifies as an "eligible investigational drug" — the critical nuance

Per 21 U.S.C. § 360bbb-0a(a)(2)–(3), the product must have completed a Phase 1 clinical trial, must not be approved/licensed, must be the subject of an active Investigational New Drug (IND) application with FDA (or a filed marketing application), and must not be discontinued or on clinical hold.

This is the point most often misunderstood or misused in marketing. An eligible investigational drug under Right to Try must, as a matter of statutory definition, already have an active IND on file with FDA and have completed Phase 1. A product with no IND at all — which describes most direct-to-consumer stem cell and exosome clinic products — categorically cannot qualify as an "eligible investigational drug" under this statute. Right to Try is not a mechanism for accessing a product that has never entered the FDA investigational pathway. FDA's own FAQ confirms: "If the IND for a drug is on clinical hold, is the drug an eligible investigational drug for use under the Right to Try Act? No." The logical extension — no IND, no eligibility — follows directly from the statutory text itself.

What the Act does and does not do

Does: exempts a sponsor from certain FD&C Act and IND-related provisions for a specific eligible patient/eligible drug pairing; requires the sponsor to file an annual summary report with FDA (doses supplied, patients treated, known serious adverse events); limits FDA's ability to use a Right to Try adverse outcome to block that drug's approval absent a documented safety-critical determination.
Does not: obligate any manufacturer to provide the product — participation is entirely voluntary. FDA's fact sheet states directly: "The Right to Try Act does not require a manufacturer or sponsor to provide access to drugs or biologics... FDA cannot require a manufacturer or sponsor to provide access."
Does not: apply to Section 361 HCT/P products in the first place — a genuinely 361-compliant tissue product does not need an IND to begin with, so Right to Try's IND-related exemptions are simply irrelevant to it.
Does not: involve FDA review or approval of individual requests. FDA's role is limited to receiving and posting the statutorily required annual summaries.

How to verify a genuine Right to Try offer