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Jul 21, 2016

The Proper Role of the FDA in the 21st Century

The current medical marketplace is 
very different  from the one that existed 
when FDA was founded in 1906.

by Dr. Joseph Gulfo

Executive Director, Rothman Institute of Innovation & Entrepreneurship



The current medical marketplace is vastly different from the marketplace that existed when the basic elements of Food and Drug Administration law were passed. Despite rapidly advancing technology and patients’ increasing desire to try new drugs and devices, the FDA has strayed significantly from the statutorily defined safety and effectiveness standards for drug approvals. The FDA now very often demands proof of clinical utility, including survival and disease outcomes, as a requirement for premarket approval. But hard proof of clinical utility is elusive, even for drugs that are clearly shown to be safe and effective as labeled. Rather than blocking safe and effective drugs on such grounds, we should allow physicians and patients to make outcome-oriented decisions, and rely on the medical marketplace to drive physician adoption of safe and effective drugs that prove to have great clinical utility in real-world settings.



This article is related to the Webinar:
Working on a Post-Inspection FDA Response
To get the full details, please access your free webinar.


This study evaluates current FDA policy toward new medical products and concludes that the FDA must return to its role as gatekeeper of safe and effective drugs and devices. The FDA has made significant incursions into private health decisions by exercising its public health mandate in a manner that was not intended by Congress. Rather than allowing doctors and their patients to determine how best to use a drug and ensuring that drugs placed in the market are safe and effective, the FDA has increasingly become concerned with controlling the outcomes of future judgments by physicians and patients regarding benefits and risks. The new medical marketplace should refocus the FDA on safety and effectiveness, leaving patients and doctors to evaluate and determine benefits and risks based on their experiences with the drugs.

To read the full article go to The Proper Role of the FDA in the 21st Century


Dr. Joseph Gulfo is the Executive Director of the Rothman Institute of Innovation & Entrepreneurship at Fairleigh Dickinson University where he established the Initiative for Patient Centered Innovation. He has more than 25 years of experience in the biopharmaceutical and medical device industries. In 2012, he received the American Business Awards’ Maverick of the Year Award and was an Ernst & Young Entrepreneur of the Year Finalist. He teaches graduate cancer biology. Prior to this, he served as President & CEO of MELA Sciences (2004-2013) and was Chairman of the Board (2011-2013). He recently testified in front of the Homeland Security and Government Affairs Committee on "Connecting Patients to New and Potential Life Saving Treatments” and his work has been published in the Wall Street Journal, Forbes, CNBC, US News & World Report, and other national publications. He is a regular contributor to The Hill. His latest book, The Care Quotient: Transforming Business Through People will be released on September 13, 2016 and is available for pre-order.





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