“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.

“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.

“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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