Commonwealth Fund April 7, 2021
Since the FDA established its accelerated approval program in 1992, it has approved 253 drugs without clear evidence of their health benefits
Public and private insurers are paying billions of dollars for drugs that have not demonstrated improved health benefits for patients
An important conversation is emerging on how public and private insurers pay for prescription drugs with limited clinical evidence. This discussion is focusing on drugs approved under the U.S. Food and Drug Administration’s (FDA) accelerated approval program, in which drugs can come to market without clearly proving health outcomes. A primary concern is that insurers and government are paying high prices for drugs that have not demonstrated they improve health outcomes for patients. Policymakers are considering options...