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The Big Data Regulator, Rebooted: Why And How The Fda Can And Should Disclose Confidential Data On Prescription Drugs And Vaccines, Christopher J. Morten, Amy Kapczynski
The Big Data Regulator, Rebooted: Why And How The Fda Can And Should Disclose Confidential Data On Prescription Drugs And Vaccines, Christopher J. Morten, Amy Kapczynski
Faculty Scholarship
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 can be deadly, and existing laws such as the Freedom of Information Act (FOIA) cannot solve the problem. We present here a wealth of new evidence about the urgency of the problem and argue that the FDA must “reboot” its rules to proactively disclose all …