FDA issues alert about efficacy and potential safety concerns with atezolizumab in combination with paclitaxel for treatment of breast cancer

By law, the Food and Drug Administration is required to determine whether a drug, device, biologic, or medical device is “safe and effective.” But the FDA determination does not control whether the Centers for Medicare & Medicaid Services will pay for it.  To satisfy CMS, medical products and services must be “reasonable and necessary,” meaning...