The FDA Imitates Backwards Europe on Drug Regulations

Europe shows what can happen when countries let bureaucratic procedures take precedence over the well-being of people suffering from rare diseases. 

Mike Feuz | June 12, 2026

Europe shows what can happen when countries let bureaucratic procedures take precedence over the well-being of people suffering from rare diseases. 

But it's not just Europe. For more than a year, families have staged protests in Georgia, which sits at the crossroads of Asia and Europe, where one in three children with Duchenne muscular dystrophy (DMD) dies annually due to a lack of access to widely available medical treatments. Duchenne is a progressive, debilitating disease that results in mobility loss, progressive heart failure, and respiratory collapse. Most patients are wheelchair-bound by the time they’re teenagers. Few live beyond their early 20s. 

Poland is witnessing a similar debate surrounding Duchenne, centering on the Polish government’s refusal to fund Duchenne therapies, including a steroid treatment whose cost, according to one estimate, amounts to roughly 0.06% of that country’s healthcare budget.

We like to think we’re immune to such abject policy failures, but they’re a warning of what could go wrong in the United States when public health agencies like the Food and Drug Administration (FDA) act less like a patient ally and more like a barrier to rare disease........

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