Montana's SB535 and a Potential Biotech Renaissance in America - Marginal REVOLUTION

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In 2024, China’s NMPA approved 83 new drugs, the FDA approved 50. China’s share of new commercial clinical trials jumped from 8% globally in 2013 to 30% in 2024, just behind the US at 35%. Last year, China-based Jiangsu Hengrui Pharmaceuticals overtook AstraZeneca as the top clinical trial sponsor in the world.

What’s remarkable is how China is winning: deregulation and capitalism. It’s faster and easier to set up a clinical trial in China than in the United States. China is even experimenting with the peer approval model I’ve long advocated. The Medical Tourism Pilot Zone on Hainan island lets medical institutions import and use any pharmaceutical or device approved in the EU, US, or Japan — no separate Chinese approval needed. China is using our own regulatory judgments to get treatments to its patients faster than we do.

The core problem is that our clinical trial and drug approval system is slow and expensive. Getting a new drug to market in the US takes billions of dollars and a decade or more of clinical trials — and all of that before a company earns a single dollar. The consequence is drug lag and drug loss and also learning loss. Innovation is a dynamic process. You must build to build better.

It’s not over for the United States, however. Montana’s SB535, signed into law in May 2025, is the most important regulatory innovation in drug approval in my lifetime. The law authorizes investigational drugs and therapies that have cleared Phase I trials to be prescribed and sold — bypassing the traditional FDA approval pathway. It makes Montana the first state to license experimental treatment centers, "one stop shops" for otherwise hard-to-access care.

This is a very big deal.

SB535 makes Montana the only state in the nation where firms can move more quickly from a successful Phase I trial into limited commercialization. This positions Montana as a highly attractive location for biopharma, biotherapeutics, and other life sciences companies that want to accelerate time-to-market while continuing the federal FDA approval process.

Montana’s regulatory system creates the possibility of a self-funding clinical pipeline: companies using early commercial revenues to finance the path to full FDA approval. You get treatments to patients faster, and you keep companies alive long enough to prove their treatments work. Experimental treatments are not for everyone–these treatments are cash based–no Medicaid or Medicare and probably no private insurance either–but after conventional treatments have failed experimental treatments should be available for some patients, both for their benefit and for ours.

Montana is not alone. Florida now allows non-FDA approved stem cell therapies:

A new law in Florida, CS/CS/SB 1768, allows physicians to market and administer stem cell therapies that have not been approved by the U.S. Food and Drug Administration (FDA) for orthopedic conditions, wound care and pain management.

These experiments in regulatory federalism are vital and not just for patients but also for geopolitical competition. I am thrilled China is pursuing medical innovation (I predicted and applauded this in my TED talk) but I also don’t want to see America falling behind.

The Trump administration has been supportive. I would like to see HHS and the FDA working with companies operating under state right-to-try frameworks — sharing data, clarifying federal-state boundaries favorably, and treating these experiments as the biotech competitiveness infrastructure they are.

The FDA approval process has long been treated as the only legitimate path to market. The cost of that orthodoxy is measured in companies that never reached viability, innovations that never got off the ground, and patients who died when they didn’t have to. I have spent thirty years trying to get people to see the invisible graveyard. That’s hard. Most remain blind. But China’s bursting pipeline of new drugs is visible — could this be a Sputnik moment for biotech?

An American biotech renaissance — driven by AI, federalism, and regulatory innovation — is possible. The path forward is to double down on what makes America great: the laboratories of democracy are working, and in Montana and Florida, so are the labs.

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