Montana Right to Try Framework Targets Biopharma Growth
The state's new framework offers an alternative route for clinical data collection and market access in the United States.
Updated on Oct. 16, 2026 in Biotech
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Montana Governor Greg Gianforte recently presented the state's Right to Try framework to biopharma companies in Bengaluru, India. This policy allows patient access to experimental treatments after initial Phase I safety data is established.
Why it matters
The framework provides an alternative pathway for international biopharma firms to enter the U.S. market and gather real-world clinical data while moving toward broader regulatory approval.
The framework relies on an independent review board composed of 5 medical professionals to evaluate Phase I safety data. This mechanism allows for clinical data collection at participating Montana clinics prior to formal market authorization.
The players
Greg Gianforte
The current Governor of Montana who is promoting state-specific regulatory pathways to international markets.
Montana Bioscience Alliance
An organization that facilitates navigation of the local biotechnology ecosystem for incoming firms.
The details
Under this framework, patients travel to Montana to receive experimental treatments at designated clinics. An independent board of 5 medical professionals reviews established Phase I safety findings—the initial testing stage for drug safety in humans—to approve access. This process enables manufacturers to generate real-world clinical data and potential revenue while navigating their path toward wider regulatory approval.
Timeline
October 7, 2026: Governor Greg Gianforte visited Bengaluru for a roundtable discussion.
The Tech Race
Montana's framework acts as a localized expansion of the federal Right to Try Act. It attempts to carve out a unique clinical development niche that competes for international investment by offering accelerated, though regulated, patient access.
Biopharma companies based in India may now leverage Montana-based clinics to collect clinical evidence while concurrently working toward national approval. The model requires firms to navigate state-level board reviews rather than relying exclusively on standard federal pipelines.
The takeaway
This policy creates a tangible bridge for international firms to secure early clinical data in the U.S. while operating in a state-level sandbox. Interested observers should monitor the board's approval criteria for non-conventional medical products as the framework matures.
Further reading
Explore more developments in the field within our Biotech section.
Source note: This article includes information reported by Biospectrumindia.
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Should states allow patients to access experimental treatments before they receive full federal regulatory approval?
