Health Options Foreclosed: How the Fda Denies Americans the Benefits of Medical Research

63 Pages Posted: 7 Jun 2018

See all articles by Marc D. Joffe

Marc D. Joffe

Public Sector Credit Solutions

Ariel Slonim

George Mason University, Department of Economics, Students

Date Written: 09/12/2016

Abstract

In recent decades, the Food and Drug Administration (FDA) has assumed increasing premarket authority for drugs and devices. Given how the FDA’s regulatory stance has inhibited breakthroughs in the development of medical products, it appears that the agency will stand in the way of emerging technologies such as nanotechnology, synthetic biology, nanorobotics, virally delivered telomerase, and cellular therapy. These new technologies represent not only the means to prevent and cure diseases, but also the key to helping people live longer and healthier lives. We conclude, therefore, that an incremental approach to reform—one that would keep the FDA as the sole arbiter of new medical technologies—is unlikely to work. Rather, we think that a regulatory system based on competitive market approval of drugs and devices is more likely to strike the appropriate benefit-risk balance, including that inherent in the compassionate use of experimental medical treatments.

Suggested Citation

Joffe, Marc D. and Slonim, Ariel, Health Options Foreclosed: How the Fda Denies Americans the Benefits of Medical Research (09/12/2016). MERCATUS WORKING PAPER, Available at SSRN: https://ssrn.com/abstract=3191447 or http://dx.doi.org/10.2139/ssrn.3191447

Marc D. Joffe (Contact Author)

Public Sector Credit Solutions ( email )

1655 N. California Blvd.
Suite 223
Walnut Creek, CA 94596
United States
14155780558 (Phone)

HOME PAGE: http://www.publicsectorcredit.org

Ariel Slonim

George Mason University, Department of Economics, Students ( email )

Fairfax, VA
United States

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

Paper statistics

Downloads
14
Abstract Views
243
PlumX Metrics