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Volume 109 – Issue 2

Note: I Get By with a Little Help from My 750-Dollar-Per-Tablet Friends: A Model Act for States to Prevent Dramatic Pharmaceutical Price Increases

Note: I Get By with a Little Help from My 750-Dollar-Per-Tablet Friends: A Model Act for States to Prevent Dramatic Pharmaceutical Price Increases By Alexander Walsdorf. Full Text Here. What can be done to prevent pharmaceutical companies from dramatically increasing the price of their drugs or other products? The past few years have seen multiple…

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The Morality of Compulsory Licensing as an Access to Medicines Tool

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…

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Drug Approval in a Learning Health System

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…

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Regulatory Silence at the FDA

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,…

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