Chapter 1 examines the actions of drug companies in raising prescription drug prices in the United States, as well as the effects of these actions on the Federal and state budgets, and on American families. Chapter 2 addresses frequently asked questions about government and private-sector policies that affect drug prices and availability. Among the prescription drug topics covered are federally funded research and development, regulation of direct-to-consumer advertising, legal restrictions on reimportation, and federal price negotiation. The 340B Drug Pricing Program requires drug manufacturers to sell outpatient drugs at discounted prices to covered entities-eligible clinics, hospitals, and others-in order to have their drugs covered by Medicaid. Covered entities are only allowed to provide 340B drugs to certain eligible patients. Chapter 3 reviews the Health Resources and Services Administration's (HRSA) oversight of the 340B Program to ensure compliance with program rules. In 2017, nearly 60% of U.S. adults aged 18-64 reported being prescribed medication in the past 12 months. Approximately 70% of prescription medications carry out-of-pocket costs. Strategies to reduce prescription drug costs at the individual level are discussed in chapters 4 and 5. Each year, Americans pay more for prescription drugs, and rising drug prices have a disproportionate impact on older Americans. Chapter 6 examines the history of rising drug prices for the brand-name drugs most commonly prescribed for seniors. Generic drugs-copies of brand-name drugs-lead to significant cost savings. Before a generic drug can be marketed, FDA must approve the generic drug application. According to FDA, applications go through an average of three cycles of review before being approved, which may take years. Chapter 7 examines 1) the first review cycle approval rate of generic drug applications in recent years and factors that may have contributed to whether applications were approved; and 2) changes FDA has made to increase the first review cycle approval rate.
