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

66 Pages Posted: 29 Sep 2020 Last revised: 16 Jun 2021

See all articles by Christopher Morten

Christopher Morten

Columbia Law School; Yale Law School

Amy Kapczynski

Yale University - Law School

Date Written: September 18, 2020

Abstract

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 safety and efficacy data for drugs and vaccines with minimal redactions, deploying data use agreements to ensure the most sensitive data is handled appropriately. In line with the literature that has been critical of simplistic calls for “transparency,” we urge a more contextual form of “data publicity.” We also show that clinical trial data publicity can be achieved without legislative reform, while respecting privacy, protecting any legitimate trade secrets, and maintaining or improving incentives to innovate. The FDA must adapt to protect and expand structural accountability and to protect the public and its trust. The model we offer here could guide similar action at other regulatory agencies as well, enabling better oversight of information-intensive industries and helping safeguard the agencies themselves.

Suggested Citation

Morten, Christopher and Morten, Christopher and Kapczynski, Amy, The Big Data Regulator, Rebooted: Why and How the FDA Can and Should Disclose Confidential Data on Prescription Drugs and Vaccines (September 18, 2020). 109 Calif. L. Rev. 493 (2021), Yale Law School, Public Law Research Paper Forthcoming, Available at SSRN: https://ssrn.com/abstract=3696503 or http://dx.doi.org/10.2139/ssrn.3696503

Christopher Morten (Contact Author)

Columbia Law School ( email )

435 West 116th St
NEW YORK, NY 10027

HOME PAGE: http://www.law.columbia.edu/faculty/christopher-morten

Yale Law School ( email )

127 Wall Street
New Haven, CT 06510
United States

HOME PAGE: http://law.yale.edu/ghjp/who-we-are

Amy Kapczynski

Yale University - Law School ( email )

P.O. Box 208215
New Haven, CT 06520-8215
United States

Do you have a job opening that you would like to promote on SSRN?

Paper statistics

Downloads
221
Abstract Views
1,591
rank
176,693
PlumX Metrics