The author of the article also seems to imply that FDA approval is the only process by which a treatment could be "proven effective." There are many treatments that are already available in Europe but spend years waiting for FDA approval.

There's also the fact that even when a drug does successfully pass through the FDA testing process, there can be a period of up to a year between the drug being successful in Phase 3 trials and actually getting approved for prescription. If you're a terminally ill patient, a 12 month waiting period between "proven in phase 3 trial" and "actually finally getting the FDA's rubber stamp" can be a long time.