Introduction to: FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies

FDA in the Twenty First Century: The Challenges of Regulating Drugs and New Technologies (Columbia University Press 2015)

16 Pages Posted: 9 Sep 2015

See all articles by Holly Fernandez Lynch

Holly Fernandez Lynch

Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania

I. Glenn Cohen

Harvard Law School

Date Written: September 4, 2015

Abstract

In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. This paper is the introduction to a book of essays by leading scholars and government and private industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good.

It discusses effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. It also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, contributors rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions in other countries.

Keywords: FDA, drugs, globalization, technology, data, public health, off-label, pharmaceutical, mobile health, big data

JEL Classification: F15, H77, I11, I1, I18

Suggested Citation

Lynch, Holly Fernandez and Cohen, I. Glenn, Introduction to: FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies (September 4, 2015). FDA in the Twenty First Century: The Challenges of Regulating Drugs and New Technologies (Columbia University Press 2015). Available at SSRN: https://ssrn.com/abstract=2656165

Holly Fernandez Lynch

Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania ( email )

423 Guardian Drive
Philadelphia, PA 19104
United States

I. Glenn Cohen (Contact Author)

Harvard Law School ( email )

1525 Massachusetts Avenue
Griswold Hall 503
Cambridge, 02138
United States

Register to save articles to
your library

Register

Paper statistics

Downloads
208
rank
143,153
Abstract Views
1,047
PlumX Metrics