The Proper Role of the Fda for the 21st Century

38 Pages Posted: 7 Jun 2018

See all articles by Jason Briggeman

Jason Briggeman

Austin Community College - Department of Economics

Ethan Roberts

Independent

Joseph Gulfo

Fairleigh Dickinson University

Date Written: 02/02/2016

Abstract

The FDA’s mission is to permit safe and effective new drugs, biologics, and devices onto the market in an efficient and timely manner. But fear of being blamed for the failings of approved products has caused the FDA to become too restrictive. The FDA has strayed from the safety and effectiveness standards that are set out in the law, instead applying standards for approval that are based on predicting the benefits and risks—clinical utility, disease outcomes, survival—that an “average patient” will experience. But these outcomes are better evaluated in real-world, post-market settings—that is, in the medical marketplace, where knowledge about the value of a drug or device for different types of patients can grow over time. The FDA must return to its role as gatekeeper of safe and effective drugs and devices, and refrain from attempting to anticipate the future judgments of physicians and patients regarding benefits and risks.

Suggested Citation

Briggeman, Jason and Roberts, Ethan and Gulfo, Joseph, The Proper Role of the Fda for the 21st Century (02/02/2016). MERCATUS RESEARCH. Available at SSRN: https://ssrn.com/abstract=3191411 or http://dx.doi.org/10.2139/ssrn.3191411

Jason Briggeman (Contact Author)

Austin Community College - Department of Economics ( email )

5930 Middle Fiskville Road
Austin, TX 78752
United States

Ethan Roberts

Independent ( email )

No Address Available

Joseph Gulfo

Fairleigh Dickinson University

1000 River Rd
Teaneck, NJ 07666
United States

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