In July 2026, Montana signed a law allowing access to experimental therapies not yet approved by the FDA. The story comes from Kris DeVault, whose son Brody, two, has a rare genetic disorder that blocks speech and movement. The genetic test gave a name, but no timely cure. The family cannot wait for ordinary timelines.
This law is the latest symptom of a systemic failure. In the US, developing a drug costs billions and takes more than a decade of trials. When the regulatory process becomes so slow, states move alone. Montana legalizes direct access. Up close, it looks like courage. From afar, it is political surrender: processes are not reformed but bypassed. The FDA's original mission was safety and efficacy. Today it has become a bottleneck where innovation dies waiting. The FDA's own right to try page explains the narrow existing framework (https://www.fda.gov/patients/right-try-treatments).
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For Europe, the issue is even more concrete. Compassionate use exists, but it is slow, discretionary, and in Italy it is a maze of authorizations very few SMEs can navigate. The result: venture capital moves to the US, where clinical trials are faster. Italian biotech firms remain trapped in a continent that demands evidence, but does not build the infrastructure to produce it. The gap is not just cultural, it is economic. A trial conducted in the US can finish in half the time, with a clearer path to market. And with the European Health Data Space in the pipeline, Europe could have the first real single market for research data. Complacency would waste it.
The real bottleneck is technological. Gene therapies depend on a massive amount of clinical data. Without shared standards, digital consent, interoperability between hospitals and real-world evidence platforms, no agency can deliver fast and safe reviews. Precision medicine without precision data is just a slogan. The problem is not the rules. It is that we have not built the infrastructure to make them work.
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Our position is clear
We, at Meteora Web, build digital tools for almost a decade. We think in terms of costs, time, and return. Right to try is sacred. But deregulation is not a solution: it is a transfer of risk from the system to the patient. The right answer is a European health data infrastructure: digital informed consent, continuous monitoring, decentralized trials. That is how you shorten timelines without cutting corners. Selling right to try as freedom is storytelling. Data matter. Transparency matters. Rules change by building an alternative, not by asking for an exception. We are not doctors. We know digital infrastructure. Every system we have ever built starts with clean data and clear consent. We see the pattern daily in client projects: automatable processes, data locked in silos, authorizations managed by hand. Same pattern in every industry.
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Whoever works in digital in Italy today can choose a side. Read AIFA's compassionate use programs and the European Health Data Space regulation. Join PNRR healthcare calls. Build tools that put patient consent and data quality first. That is the real frontier. It is not an act of faith. It is a market demand waiting for an answer. Montana chose to react. Europe can do better: build, not bypass. The technology is ready. The political will is not.
