Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances

Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances

by Joseph V. Gulfo


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Winner of Maverick of The Year Award and Ernst & Young Entrepreneur of the Year Finalist, and featured by WSJ, Fortune and Bloomberg TV for his battle to defeat unlawful actions by the FDA, Dr. Joseph V. Gulfo provides a first-hand riveting account of an against-all odds fight that demonstrates what it takes to advance breakthrough medical products that truly benefit patients. Having been responsible for the development and FDA approval of three innovative cancer products, he provides the reader with ringside seats to the struggles that entrepreneurs of biotech and medtech companies must fight to successfully bring ideas to marketed innovative products that truly advance the lives of patients.

As exclaimed by one real-life witness to a high profile public battle recounted in the book, “It was like watching Gladiator!” The only difference is that this really happened. Sometimes life is more dramatic and unbelievable than fiction; the courtroom-like trial in front of FDA’s medical Advisory Panel is certainly one of those times. A second was the “declaration of war” – filing a Citizen Petition against the FDA demanding that it follow its own laws and acts transparently in honoring its binding agreements. A third was a Congressional Hearing at which the FDA subsequently admitted that a mistake was made. The book contains public record facts woven together in a series of compelling stories complete with unique characters and deeply personal insights. Unrelenting focus, even to the level of personal destruction, and leadership through crises are other major themes.

Part One describes how medical innovation occurs in small companies and details the challenges in moving those start-ups along a course that is anything but straightforward. It addresses issues such as the psychology of inventors and founders versus investors, the challenges of attracting and retaining talent, and the vagaries of early phase product development.

Part Two takes a deep dive into the unlawful actions and cover-ups by the U.S. FDA that had to be overcome in our effort to obtain approval of a non-invasive product that saves lives. It is a brutal blow-by-blow account of a public slugfest that forever damaged the company.

Part Three explains how the unnecessary and very public battle with the FDA left an indelible mark on the company, a taint that was exploited by nefarious Wall Street actors who then preyed on the company for their own benefit. It details how with a Scarlet Letter on its back and an albatross around its neck, Wall Street’s short sellers and dark pool traders hamstrung the course toward widespread use and adoption.

The book concludes with The Innovation Manifesto, an actionable list of changes to help fix this horribly broken system, including reform to the legal system to reduce meritless shareholder lawsuits; securities reform to stop manipulative trading, analysis, and predatory shorting of small companies; and FDA reform that will bring in leadership that is committed to, and unafraid of, promoting health by proactively advancing the development and approval of innovative products, rather than simply blocking drugs and devices that are not deemed to be safe. The FDA needs to get back to its first principles and to stop the propaganda - the author knows how to make that happen.

In medical school and residency, the author was taught to “see one, do one, and teach one” as the means to master a procedure and to complete the “circle of education.” With respect to biotech and medtech companies that have been severely compromised by an untenable system, having “seen one, done one, and taught one” he now seeks to “prevent a hundred” similar unfortunate examples. Continued advancement of our national health depends on it.

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Product Details

ISBN-13: 9781682613917
Publisher: Post Hill Press
Publication date: 03/07/2017
Pages: 272
Product dimensions: 5.50(w) x 8.20(h) x 0.90(d)

About the Author

Joseph V. Gulfo, MD, MBA, is the author of Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances. He is Executive Director of the Rothman Institute of Innovation and Entrepreneurship at Fairleigh Dickinson University and a Visiting Scholar at the Mercatus Center of George Mason University. A contributor to The Hill and, he also teaches graduate cancer biology, business and entrepreneurship classes and maintains an educational cancer biology blog.

A serial entrepreneur, Dr. Gulfo is a leader in biopharma and medtech innovation. He is passionate about removing obstacles to breakthrough innovation, managing start-up companies, cultivating young managers, and developing products that can make a huge difference in the lives of patients and individuals. He received his MD from University of Medicine and Dentistry of New Jersey, and his MBA from Seton Hall University. He lives in New York, NY.

Table of Contents

Introduction 1

Chapter 1 I Don't Want to Fight Anymore 5

Chapter 2 From Star Wars to Skin Cancer 25

Chapter 3 Innovation is Hard Enough 39

Chapter 4 FDA Part I: What's Supposed to Happen 76

Chapter 5 FDA Part II: The Letter Bomb 103

Chapter 6 FDA Part III: Taking Matters Into Our Own Hands 139

Chapter 7 $160 Million The Hard Way 166

Chapter 8 Let's Not Forget-This Machine Saves Lives! 202

Chapter 9 I Don't Want to Fight Anymore, Part II 225

Chapter 10 The Medical Innovation Manifesto 246

Acknowledgments 259

For More Information 262

What People are Saying About This

From the Publisher

"By focusing on the fate of one small company, Joseph Gulfo has written a riveting tale of how the FDA slows down crucial medical innovations, just when we need them the most. Policymakers on both sides of the aisle should absorb his prescriptions for fixing the system.

Michael Mandel, PhD Progressive Policy Institute

"Finally, an incisive look at the path that medical innovation takes through the FDA, the courts and the public advocacy groups and the crippling effect it has on advancing new treatments to treat and diagnose disease. Today’s regulatory/legal/public advocacy complex is stifling progress and killing medical breakthroughs. Joseph Gulfo lays out why this has happened, how to fix it and how to make all our voices heard."

Nancy Lurker, CEO, PDI Inc.

"Finally, a behind-the-scenes look at the mysterious and often poorly executed approvals process of the FDA. An important book for consumers, physicians, investors, and scientists - anyone who is interested in medical advances that can save lives."

Joseph Pieroni, retired CEO and President, Daiichi Sankyo Inc.

“Dr. Gulfo has written an important book that deserves to be read by everyone interested in having access to new medical treatments. The enormous and all too often insurmountable challenges in bringing breakthrough medical products to doctors are not unique to small biotech and medtech companies, rather, even the industry-leading firms struggle against these forces. And, in the end, it’s the patients who suffer.”

Brian Leyland-Jones, MD, Vice President, Molecular and Experimental Medicine, Avera Cancer Institute, Sioux Falls, SD

“A fascinating read of the relentless challenges a passionate entrepreneur faced and overcame to bring a medical breakthrough to patients.”

Susan Scherreik, Founding Director, Seton Hall University Center for Entrepreneurial Studies

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