FDA Approval Process Costs $25 Million and 18 Months Before Human Trials Even Begin

What was said

"Right now, in order to do a clinical trial of what we call a first-in-human, the first time you give a drug to a human, a new drug, in order to do that in the United States right now, you need to write an IND, which is called an initial new drug application, to the FDA. It's very long. I think ours for our first trial was 22,000 pages long. Just to write it, it costs millions of dollars. The manufacturing of your drug and the associated analytics of your drug in order to be correct in the document costs millions of dollars. And all of a sudden this application costs you $25 million."

Becraft detailed the crushing cost of FDA regulatory burden, revealing that biotech companies must spend $25 million and 18 months just to file paperwork before testing new drugs in humans. He contrasted this with Australia and China's notification systems that allow companies to proceed directly to hospital review boards. This regulatory bottleneck forces companies into only the top hospitals, denies American patients access to experimental treatments, and incentivizes offshoring of innovation.