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

61 Pages Posted: 29 Sep 2020

See all articles by Christopher Morten

Christopher Morten

New York University School of Law; 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 FDA holds an enormous reservoir of data on that sheds light on that precise question, yet currently releases only a trickle to researchers, doctors, and patients. Existing processes that might allow public access to such data, such as FOIA, have failed, and reactive disclosure as a model cannot succeed. 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 redaction — what we deem “data publicity.” We also provide a road-map to enable this data publicity and show that it can be done without legislative reform, while respecting privacy, protecting any legitimate trade secrets, and maintaining or improving incentives to innovate.

The regulatory state in the information age faces enormous challenges. Medicines and vaccines are just two examples of the enormous array of products that are increasingly information-ally complex. The FDA must adapt to protect and expand structural accountability, and to protect the public and its trust. The model we offer here could, we suggest, become a template for other regulatory agencies, enabling better oversight of information-intensive industries and helping safeguard the agencies themselves.

Suggested Citation

Morten, Christopher and Kapczynski, Amy, The Big Data Regulator, Rebooted: Why and How the FDA Can and Should Disclose Confidential Data on Prescription Drugs (September 18, 2020). California Law Review, Forthcoming, Available at SSRN: https://ssrn.com/abstract=3696503 or http://dx.doi.org/10.2139/ssrn.3696503

Christopher Morten (Contact Author)

New York University School of Law ( email )

2129986042 (Phone)
10012-1301 (Fax)

HOME PAGE: http://https://www.law.nyu.edu/centers/engelberg/team/morten

Yale Law School ( email )

127 Wall Street
New Haven, CT 06510
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HOME PAGE: http://https://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

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