Changing FDA Approval Standards: Ethical Implications for Patient Consent

The FDA has progressively relaxed premarket evidence requirements for drugs and devices over several decades, through programs like accelerated approval, breakthrough therapy designation, and real-world evidence provisions, resulting in a growing number of products reaching patients with limited clinical data. The authors argue that the informed consent process has not kept pace with these changes, creating ethical challenges as patients and physicians make treatment decisions about products with increasingly uncertain benefit-risk profiles.