Bills › 91st General Assembly
Relating to the right to try Act
Sponsored by the Senate Health and Human Services Committee, Sen. Jeff Taylor (R)
Topics:Health care
Where it is now
- Done: IntroducedJanuary 16, 2025
- Done: SubcommitteeJanuary 21, 2025
- Done: Senate committeeFebruary 10, 2025
- Done: Passes the SenateMarch 18, 202548–0
- Done: House committeeMarch 18, 2025
- Done: Passes the HouseMarch 20, 202589–0
- Done: To the GovernorMay 19, 2025
- Done: Signed into lawMay 19, 2025
Signed into law What’s a funnel?
What’s in it
This bill relates to Code chapter 144E, the right to try Act. Under current law, an “eligible patient” under the Code chapter is, in part, a person who has a terminal illness. Under the bill, an “eligible patient” also includes, in part, a person who has a life-threatening or severely debilitating illness. Under current law, the Code chapter applies to an “investigational drug, biological product, or device”, meaning a drug, biological product, or device that has successfully completed phase I of a United States food and drug administration (FDA)-approved clinical trial but has not yet been approved for general use by the FDA and that remains under investigation in an FDA-approved clinical trial.
Read the full explanation
Under the bill, the Code chapter also applies to an “individualized investigational treatment”, meaning a drug, biological product, or device that is unique to and produced exclusively for use by an individual patient based on the individual patient’s own genetic profile and includes individualized gene therapy, antisense oligonucleotides, and individualized neoantigen vaccines. The bill amends the definition for “written informed consent” to reflect the changes made to “eligible patient” and the application of the Code chapter to individualized investigational treatments. “Eligible facility” is defined as an institution that is operating under a federalwide assurance for the protection of human subjects pursuant to federal law. The bill amends provisions relating to a manufacturer’s rights under the Code chapter to also apply to eligible facilities. The bill provides that a manufacturer of an investigational drug, biological product, or device or a manufacturer operating within, and in compliance with all requirements applicable to, an eligible facility may make available, and an eligible patient may request from a manufacturer of an investigational drug, biological product, or device, or a manufacturer operating within, and in compliance with all requirements applicable to, an eligible facility, the manufacturer’s investigational drug, biological product, or device, or the manufacturer’s individualized investigational treatment. However, the Code chapter does not require a manufacturer of an individualized investigational treatment to provide or otherwise make available the individualized investigational treatment to an eligible patient. The bill provides that an eligible facility or a manufacturer that is in compliance with all applicable requirements may provide an individualized investigational treatment to an eligible patient without receiving compensation, or require an eligible patient to pay the costs of, or the costs associated with, the manufacture of the individualized investigational treatment. The bill makes conforming changes in the Code chapter.
From the explanation printed with the bill as introduced, written by the Legislative Services Agency. Changed since by amendments H-1132, H-1131; see Amendments. Full bill text · What changed before it passed
Iowa Code it changes
Amends§144E.2§144E.3§144E.4§144E.5§144E.6§144E.7§144E.8
Read from the bill as introduced. Each links to every bill touching that chapter of the Iowa Code. How the Code works
Lobbying
4 for · 0 against · 13 undecided · Who →
Family tree
Where this legislation came from and where it went: earlier tries, the versions it moved through this Assembly, and later bills built on it.
Tried before
Earlier and later bills are matched by wording or an identical title; check the text to be sure it’s the same idea.
Tried before
This idea has been filed in an earlier General Assembly. None got through a chamber.
- HF 225 Relating to the right to try Act90th General Assembly · Subcommittee recommends passage · same titleCleared committee
- SF 2323 Relating to the right to try Act90th General Assembly · Approved by committee · same titleCleared committee
- HF 2290 Relating to the right to try Act90th General Assembly · In committee · very similarCleared committee
Matched by the wording of each bill’s explanation, or an identical title. Companion bills and renumbered versions of this bill aren’t listed; they’re the same bill.