The Morality of Compulsory Licensing as an Access to Medicines Tool By Margo A. Bagley. Full Text Here Drug prices are soaring in rich and poor countries and are reducing access to medicines for many people who need them the most. Nevertheless, efforts by governments, activists, scholars, and others to reduce costs through mechanisms such…

Drug Approval in a Learning Health System By W. Nicholas Price II. Full Text Here. The current system of Food and Drug Administration (FDA) approval seems to make few happy. Some argue that FDA approves drugs too slowly; others, too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to…

Regulatory Silence at the FDA By Jordan Paradise. Full Text Here. Action speaks louder than words, but silence often speaks loudest. Where statutory language specifically directs a federal administrative agency to act, the agency must adhere to the conditions and timeframe provided by Congress. Yet the statute may instead give general authority to an agency,…

Dangerous Times: The FDA’s Role in Information Production, Past and Future By Amy Kapczynski. Full Text Here. The FDA faces many current threats to its power as a drug regulator. Many so-called right-to-try bills have passed at the state level, and versions have been introduced federally that could reduce or eliminate the Agency’s ability to oversee…

Delinking Reimbursement By Rachel E. Sachs. Full Text Here. Over the past few years, calls for the Food and Drug Administration (FDA) to approve pharmaceuticals more speedily have grown louder. At the same time, many have argued that America’s drug pricing problems can be solved if only Congress were to give Medicare the authority to…

What Makes Ensuring Access to Affordable Prescription Drugs the Hardest Problem in Health Policy? By Michelle M. Mello. Full text here. Prescription drug costs have risen to an unsustainable level in the United States, accounting for one out of every six dollars spent on health care and compromising many patients’ ability to afford the pharmaceutical…