The Big Data Regulator, Rebooted: Why and How the FDA Can and Should Disclose Confidential Data on Prescription Drugs and Vaccines

Medicines and vaccines are complex products, and it is often extraordinarily difficult to know whether they help or hurt. The Food and Drug Administration (FDA) holds an enormous reservoir of data that sheds light on that precise question, yet currently releases only a trickle to researchers, doctors, and patients. Recent examples show that data secrecy […]

Harmonization and Its Discontents: A Case Study of TRIPS Implementation in India’s Pharmaceutical Sector

In recent years, several controversial new intellectual property treaties have been adopted, most importantly the World Trade Organization’s TRIPS Agreement. Proponents argued that TRIPS would promote global trade and innovation by requiring developing countries to adopt western-style IP protection. Critics allege that the Agreement has potentially devastating implications for developing countries, particularly with regard to […]