[nradov]

You have a flawed understanding of the FDA pharmaceutical approval process. There is no bias towards either rejection or approval. If an drug application checks all the required boxes then it will be approved.

I think the reason why some people mistakenly think this makes healthcare more expensive is that over recent years the FDA has raised the quality bar on the clinical trials data they will accept. A couple decades ago they sometimes approved drugs based on studies that were frankly junk science. Now that standards have been raised, drug trials are generally some of the most rigorous, high-quality science you'll find anywhere in the world. Doing it right is necessarily expensive and time consuming but we can have pretty high confidence that the results are solid.

For patients who can't wait there is the Expanded Access (compassionate use) program.

https://www.fda.gov/news-events/public-health-focus/expanded...