Committee broadens Right‑to‑Try eligibility to "life‑threatening" illnesses and removes clinical‑trial requirement in HB 4610

Counsel explained that House Bill 4610 would amend definitions under the Right to Try Act so an eligible patient need not have a terminal illness but must have a life‑threatening or severely debilitating illness attested to by a treating physician. Counsel said the bill removes a requirement that patients be unable to participate in clinical trials and expands the definition of "investigational drug" to include individualized biologics and gene therapies produced for a single patient.

Counsel noted the amendment includes a written informed‑consent provision stating a patient may be liable for expenses resulting from investigational drugs, biologics or devices and that liability could extend to the patient’s estate unless a contract with a manufacturer states otherwise. "Under the section on written informed consent, it states patient understands he or she may be liable for all expenses consequent to the use of investigational drug, biological product or device," counsel said.

Senators asked about reimbursement and who would bear the cost of very expensive individualized therapies; counsel said the bill anticipates informed consent would explain possible costs and that manufacturers in some instances could cover expenses. A senator asked whether the change mirrors a bill considered last year; counsel said the current proposal is similar and compiles related concepts into the version before the committee.

The committee adopted the counsel‑explained amendment by voice vote and then voted to report House Bill 4610 to the full Senate with a recommendation that it pass as amended, with a first referral to the Committee on Judiciary under the original double committee reference.

The bill’s changes alter eligibility and definitional language and add a disclosure about potential patient liability; implementation would involve the Department named in the statute and would be effective in 90 days unless otherwise specified.