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Senate committee adopts technical amendment to bill creating pathway for individualized investigational treatments

June 18, 2025 | Health, Senate, Committees, Legislative, Ohio


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Senate committee adopts technical amendment to bill creating pathway for individualized investigational treatments
The Senate Health Committee accepted a technical amendment to Senate Bill 170 during a second hearing that would create a state pathway for individualized investigational treatments, proponents said.

The amendment, offered by Senator Roegner, corrected what Roegner described as a double negative in the bill’s text so the statute would read as intended. "So simple English correction, just corrects that double negative," Roegner said. Committee leadership said there was no objection and the amendment became part of the bill.

The bill’s proponent testimony came from Naomi Lopez, senior fellow in health care policy at the Goldwater Institute, who told the committee the proposed law would add a pathway for individualized, gene‑based treatments that are not readily handled by the conventional clinical‑trial model. "This proposed law does not change the original right to try law which was passed in Ohio and is now federal law," Lopez said. "But the trouble is is that this law needs to be upgraded and modernized to account for rapid advancements in medicine such as gene therapy which aren't covered under the original law."

Lopez described the proposed pathway as working under existing federal human‑subjects protections. In her explanation, a physician, patient and researcher or company would use a facility that holds a Federalwide Assurance and submit the individualized‑treatment plan to that facility’s institutional review board. "It has to be directed by a physician and it has to be approved by the institutional review board," Lopez said, adding that IRBs and Federalwide Assurance requirements provide informed‑consent and other human‑subject protections.

A committee member asked how difficult it is to create an individualized genetic treatment. Lopez replied she is not a physician but said the process is "difficult" and "complicated," though genetic sequencing is making identification of mutations easier. She told the committee the sponsors expect most facilities able to create individualized treatments already hold a Federalwide Assurance and that those rules have been used for decades.

Lopez also cited examples and litigation‑adjacent anecdotes in her testimony, including a family that sought treatment abroad for a child identified as Keira Riley. Written testimony from Hannah Kubens of Americans for Prosperity of Ohio was also entered into the record.

The hearing was informational and procedural: the committee adopted the Roegner amendment by unanimous consent, but took no final vote on the bill itself. The committee clerk recorded the amendment’s acceptance and the hearing was closed.

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