Bill
HB 25-1270
Expands patients' access to investigational or individualized treatments after exhausting standard options, with physician oversight, informed consent, and liability protections.
Status: Governor Signed (May 19, 2025)
Introduced: February 18, 2025
Primary Sponsors: Lindsey Daugherty; Barbara Kirkmeyer; Lindsay Gilchrist; Rose Pugliese (plus many cosponsors listed)
Legislative progress: Passed both chambers with no amendments; sent to and signed by governor in May 2025.
Note: The official bill text was not provided with your request. The summary below identifies the bill’s apparent purpose from its title and legislative status, outlines commonly included provisions in “right to try” or “individualized treatment” statutes, and notes potential effects and considerations. For exact legal language and operative sections, consult the enrolled bill text on the Colorado General Assembly website or the governor’s office.
Purpose and intent
- The bill’s title, “Patients’ Right to Try Individualized Treatments,” indicates the intent to expand or clarify patients’ legal ability to access investigational, off-label, or individualized medical treatments when standard therapies have been exhausted. Such laws aim to give patients with serious or terminal conditions additional options outside of approved clinical trials.
Likely key provisions (based on typical right‑to‑try frameworks)
- Definitions: who qualifies as a patient (e.g., terminal/serious condition), what counts as an “individualized” or “investigational” treatment.
- Eligibility criteria: patient diagnosis, exhaustion of approved treatments, physician determination that no comparable standard treatment is available.
- Informed consent: requirements for written patient consent and physician documentation about risks and lack of guaranteed benefit.
- Provider/physician role: authorization for treating clinicians to prescribe or administer individualized treatments and responsibility for patient counseling and monitoring.
- Manufacturer and pharmacy provisions: process for obtaining investigational products; voluntary participation by drug/device manufacturers.
- Liability and immunity: civil liability protections for physicians, providers, and manufacturers acting in good faith; likely does not shield against gross negligence or willful misconduct.
- Clinical trial safeguards: statements meant to avoid interference with clinical trial enrollment and to clarify that participation in right‑to‑try does not confer investigational product approval.
- Reporting/oversight: possible requirements for reporting outcomes, adverse events, or utilization to a state agency (varies by law).
Who is affected
- Primary: patients with serious or terminal illnesses who have exhausted standard treatments and their treating clinicians.
- Secondary: hospitals, clinics, specialty pharmacies, manufacturers of investigational therapies, insurers (potentially for coverage/denial implications), and state health regulators.
Potential impacts and considerations
- Access: may increase access to experimental options for some patients, particularly when clinical trials are not available.
- Safety and oversight: individualized treatments carry higher uncertainty; lack of comprehensive data may increase patient risk.
- Insurance and cost: such treatments are often costly and may not be covered by insurers, shifting financial burden to patients/families.
- Clinical research: potential to reduce trial enrollment; statutes often include language to minimize disruption to research.
- Legal/ethical: clarifies consent process and liability protections, but raises equity concerns if access depends on ability to pay or manufacturer willingness.
Next steps / where to read the law
- For precise operative text, definitions, and any reporting or implementation timelines, see the enrolled bill (HB 25‑1270) on the Colorado General Assembly website or the Governor’s publications for May 2025.
Compiled from official sources — confirm details with the bill’s official record.
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