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Debate grows over experimental treatment centers bill as companies tout access and medics warn of risks
Summary
Supporters told the committee HB 1734 would create licensed 'experimental treatment centers' to offer post‑phase‑1 therapies and attract biotech investment; opponents — including the New Hampshire Medical Society — warned of weak oversight, on‑site manufacturing risks, insurance/payment concerns and ethical problems for vulnerable patients.
Lawmakers heard sharply divided testimony on HB 1734, a proposal to authorize state‑licensed experimental treatment centers (ETCs) to provide investigational drugs, biologics and devices that have completed phase‑1 trials but are not yet FDA‑approved.
Sponsor Representative Steven Kessler told the committee the measure adapts a Montana model to allow the Department of Health and Human Services to authorize qualified institutions and institute IRB and scientific review board oversight. Proponents — including biotech founders, CEOs and researchers — argued ETCs would bring advanced therapies to New Hampshire patients now traveling abroad for care, help small companies collect clinical data, and spur local economic growth.
Opponents, led by the New Hampshire Medical Society, urged caution. Mora Weston said phase‑1 trials are limited to assessing safety in a small number of subjects and do not establish efficacy. She and other physicians warned that allowing on‑site manufacturing or compounding, permitting direct patient charges, and restricting board authority could expose patients to harm and impede robust evidence collection. Representative Lucy Weber and Representative Janna Lucas similarly flagged ethical and oversight gaps, including minimal record‑keeping requirements and possible manufacturer influence.
Industry witnesses described situations where FDA timelines and cost make it difficult for promising therapies to progress, particularly for small patient populations and rare diseases. Several speakers noted real‑world‑data collection and modern analytic tools could accelerate later‑phase development if data collection were integrated with ETCs.
Committee members queried whether HB 1734 would conflict with existing FDA manufacturing standards (cGMP/USP compounding) and sought clarification on IRB roles and data retention. Supporters said the bill is a framework for DHHS regulation and expressed openness to added safeguards such as longer records retention, stronger IRB requirements, and site inspections.
The committee recessed without a vote; sponsors and opponents signaled possible follow‑up amendments to strengthen safety, oversight, and reporting requirements.
