Committee hears wide-ranging debate over bill to create stem-cell "regulatory sandbox"

Sponsor testimony opened with a technical and policy history of regulatory pathways and the stated goal of HB 12-92: to create state-level authority for licensed physicians to provide certain regenerative stem-cell and tissue therapies under a New Hampshire framework while preserving informed-consent protections and manufacturing safeguards.

"This bill would provide opportunities for people to heal from stem cell and tissue therapies that currently are stalled, because of the process at the FDA," the sponsor said, describing past experience as a medical device analyst and arguing that a state "regulatory sandbox" could help innovation and economic development.

Noah Keating, director of strategy at EpiBone, described the bill as modeled in part on Florida’s SB 1768 and said companies and clinicians had found the Florida framework useful to scale treatments under physician supervision while meeting manufacturing and facility standards. Keating said he has seen interest from doctors and companies and argued this is not deregulation but a pathway with "federal regulatory oversight of manufacturing" and informed-consent protections.

Attorney testimony from a Cornerstone representative said much of the proposed text (especially the regulatory and manufacturing sections) is copied from Florida law and defended its guardrails, while also noting drafting and housekeeping changes intended to align state right-to-try language.

Committee members and other witnesses pressed the sponsor about patient protections, definitions and enforcement. Representative Birch asked whether the bill might expose vulnerable terminal or chronically ill patients to toxic or ineffective treatments; the sponsor pointed to informed consent and to mechanisms in the bill that would allow regulators to pierce liability if consent was inadequate. Representative Perez and others raised concerns about broad definitions such as "health care provider" and "qualifying severe illness." The sponsor said some definitions mirror federal language and that some regulatory fixes may require executive-branch licensing changes.

Supporters said HB 12-92 could attract companies and jobs to New Hampshire’s Regen Valley and Manchester lab infrastructure. Critics urged caution, tighter definitions, and clearer oversight to protect patients and avoid creating a magnet for poorly supervised therapies.

The committee received written and oral testimony from industry, patient advocates, lawyers and detractors; no committee vote occurred on the day of the hearing.