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Manhattan Institute

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Project FDA

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Manhattan Institute health policy experts advocate for utilizing 21st century technologies to help improve FDA regulations and create a faster, safer drug and medical-device pipeline. Project FDA leads national efforts to meet health care challenges with more science, not more regulation.
Health PolicyFDA Reform


Katherine Lazarski
Senior Media Manager

Jack Solowey
Manager, Health Policy

Project FDA Reports

Unlocking the Code of Health: Bridging the Gap Between Precision Medicine and FDA Regulation

by Peter W. Huber and Paul Howard, March 2014


Project FDA Committee

Andrew C. von Eschenbach, MD

Former Commissioner, U.S. Food and Drug Administration; Advisor and Former Chairman, Project FDA; Former Director, National Cancer Institute

Tom Coburn, M.D.

Former Oklahoma Senator

John F. Crowley, JD, MBA

Chairman and CEO of Amicus Therapeutics, Inc.

Joseph DiMasi, PhD

Director of Economic Analysis, Tufts Center for the Study of Drug Development, Tufts University

Henry G. Grabowski, PhD

Professor Emeritus and Director of the Program in Pharmaceuticals and Health Economics, Duke University

James J. Hsieh, M.D., Ph.D.

Associate member, Memorial Sloan-Kettering Cancer Center; Co-Founder, MSK Translational Kidney Cancer Research Program; Associate Professor, Weill Cornell Medical College

Paul Howard, PhD

Senior Fellow and Director, Health Policy, Manhattan Institute

Peter Huber, PhD, JD

Senior Fellow, Manhattan Institute

Daniel P. Petrylak, MD

Director, Genitourinary Oncology, Co-Director Signal Transduction Program, Yale University Cancer Center

Tomas J. Philipson, PhD

Professor, Harris School for Public Policy, University of Chicago

Lance K. Stell, PhD, FACFE

John and Mary West Thatcher Professor of Philosophy, Davidson College

E. Fuller Torrey, MD

Executive Director, Stanley Medical Research Institute (SMRI) and founder of the Treatment Advocacy Center

Project FDA is a Manhattan Institute initiative that aims to reform the FDA to meet 21st century challenges. Under the leadership of former FDA commissioner Dr. Andrew von Eschenbach, Project FDA promotes reforms that can enable the FDA to offer a more predictable, transparent, and efficient pathway for bringing safe and effective new products to patients.

Medicine is on the cusp of a radical transformation. New sciences and technologies are poised to allow physicians to personalize treatment for every cancer patient; arrest or prevent the development of Alzheimer's disease; and radically lower health care costs by reducing the prevalence of expensive chronic diseases. Unfortunately, today's FDA has struggled to adapt its regulations to new scientific advances.

"The report and ad are part of what is becoming a deafening chorus of voices that believe FDA needs the help of external expertise when it comes to regulatory decision-making on biomarkers."

—Sue Sutter, The Pink Sheet Daily, October 15, 2015

Project FDA believes the FDA can become a bridge for innovation, rather than a barrier to it, and that this can be achieved without sacrificing patient safety. For instance, advances in molecular medicine that allow companies to target specific sub-groups of patients, combined with electronic health records, should allow the FDA to streamline and improve time-consuming and expensive pre-market product testing that can take a decade or more, and implement vigorous post-market surveillance of "real world" patients after drugs or devices demonstrate safety and efficacy in early testing. This approach will not only accelerate access to innovative products; it should enhance efforts to safeguard public health.

Project FDA will educate the public on the FDA's vital role in advancing medical innovation; highlight the potential for new sciences to improve health while also lowering costs; and collaborate with patients' groups, industry stakeholders, and policymakers to modernize the FDA's policies and procedures.

Precision Medicine and the FDA


Data and Technology: Keys to Precision Medicine and 21st Century Cures


Building a 21st Century Health Care System: Aligning Policy, Accelerating Cures, Delivering Hope


The Digital Future of Molecular Medicine: Rethinking FDA Regulation


Unlocking the Code of Health: Bridging the Gap Between Precision Medicine and FDA Regulation

By Peter Huber, Paul Howard, March 2015

An FDA Report Card: Wide Variance in Performance Found Among Agency's Drug Review Divisions

By Joseph A. DiMasi, Christopher-Paul Milne, Alex Tabarrok, April 2014

The Digital Future of Molecular Medicine: Rethinking FDA Regulation

By Peter Huber, May 2013

Stifling New Cures: The True Cost of Lengthy Clinical Drug Trials

By Avik Roy, April 2012

Blue Pill or Red Pill: The Limits of Comparative Effectiveness Research

By Tomas J. Philipson, Eric Sun, June 2011

How Conflict-of-Interest Rules Endanger Medical Progress and Cures

By Richard A. Epstein, October 2010

Cost of Caution: The Impact on Patients of Delayed Drug Approvals

By Tomas J. Philipson, Eric Sun, June 2010