If you had a billion dollars, you would need many billions more to push even a single thing through the FDA!

This is entirely theorical, but the $2.6 billion figure that's commonly quoted accounts for all the failures as well. If I took something that's proven in Europe but wouldn't get a patent, it presumably would manage to pass FDA regulations, it's just that without the patent protection, there's no financial incentive for an existing company to do that.