Bill would let doctors offer limited unapproved stem cell treatments

Physicians may perform certain stem cell treatments that the FDA has not approved. The rules cover physicians providing these treatments and the facilities that retrieve, make, or store the cells. The treatment must address a disease within the physician’s practice and relate to bone and joint care, wound care, or pain management. Cells must meet facility, accreditation, viability, and consent rules. Physicians must include a warning in advertisements and obtain signed patient consent. Exceptions apply to certain FDA-approved investigational uses and accredited institutions. The act would take effect January 1, 2027.

Manufacturers may make certain unapproved drugs, biologics, or devices available to patients with terminal or qualifying severe illnesses. A qualifying severe illness must be chronic and debilitating; the text also covers terminal illness. The patient’s physician and a consulting physician must determine that the patient has a covered illness, and the treating physician must find no comparable or satisfactory FDA-approved treatment available. The patient, or an authorized representative, must give written consent. Manufacturers may charge for treatment, and insurers and state agencies need not cover it. No manufacturer, provider, or facility is required to offer treatment or include a patient in a study. The act would take effect January 1, 2027.

A physician who willfully performs or actively participates in treatment or research using certain fetal or embryonic cells would commit a class B felony. It applies to physicians and to treatment or research using the specified cells or tissues. The rule covers human cells or tissues derived from a fetus or embryo after an abortion. A violation may also lead to discipline by the state medical board. The act would take effect January 1, 2027.