When most people think of the FDA, they think of safety and efficacy. And that makes sense. The agency’s job is to make sure drugs and medical devices work and that they won’t cause harm. But there’s one factor that doesn’t enter the equation, even though it affects every patient, every provider, and every payer: cost. In the United States, a drug can be approved based on clinical performance alone. If it’s shown to be safe and effective, it gets the green light. What the FD