Manhattan Institute for Policy Research.
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Andrew C. von Eschenbach, MD

Former Commissioner,
U.S. Food and Drug Administration; 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

Faculty member, Health Sector Management Program Faculty; Professor of Economics, Director of the Program in Pharmaceuticals and Health Economics, Duke University

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

Associate member at the Human Oncology and Pathogenesis Program and an associate attending physician at the Genitourinary Oncology Division at the Memorial Sloan-Kettering Cancer Center, and an associate professor at the Weill-Cornell Medical College.

Paul Howard, PhD

Senior Fellow and Director, Center for Medical Progress, 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.

TheCure in the CodeProject 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 timeconsuming 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.


The Digital Future of Molecular Medicine: Rethinking FDA Regulation

At a Manhattan Institute Project FDA conference, leading scientific and technical experts, industry stakeholders, and experienced FDA regulators discussed how we can better incorporate new technologies into the drug development process in order to accelerate biomedical innovation and improve outcomes for patients.

Framing the conference, senior fellow Peter Huber presented his report, The Digital Future of Molecular Medicine: Rethinking FDA Regulation, examining how rapid advances in the science of personalized medicine are being slowed by an outdated regulatory system that relies on 50-year-old statistical models to evaluate new medicines.
More on this event...


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

In the Wake of Wyeth v. Levine: Making the Case for FDA Preemption and Administrative Compensation
By James R. Copland, Paul Howard, March 2009

What Failed, the New Cancer Treatment or Regulators?, By Peter Huber and Paul Howard, Wall Street Journal, 02-03-15
FDA Reform Can Lift U.S. Economy, Tomas J. Philipson & Andrew von Eschenbach, Bloomberg, 02-28-13
FDA Approvals Are a Matter of Life and Death, Andrew von Eschenbach, Wall Street Journal, 06-17-12
Toward a 21st-Century FDA, Andrew von Eschenbach, Wall Street Journal, 04-15-12
Medical Innovation: How the U.S. Can Retain Its Lead, Andrew von Eschenbach, Wall Street Journal, 02-14-12
Former FDA Commissioner Andrew von Eschenbach To Head Manhattan Institute's Project FDA Initiative

Biotech Industry In Early Phase Of Sustainable Growth Trend
Paul Howard and Peter Huber, Investor's Business Daily, 09-24-15
To Lower Drug Prices, Innovate, Don’t Regulate
Paul Howard, New York Times “Room for Debate”, 09-23-15
How Can Policymakers Bridge the Gap Between Precision Medicine and FDA Regulation?
Paul Howard and Peter Huber, Food and Drug Policy Forum Volume 5, August 2015
Innovation And Its Discontents: FDA Regulation, Competition, And Drug Pricing
Paul Howard, The Morning Consult, 02-09-15
21st Century Cures Is Good Health (And Fiscal) Policy
Paul Howard, Yevgeniy Feyman,, 07-09-15
21st Century Cures Legislation: Embracing The Future Of Medicine
Andrew von Eschenbach, Paul Howard, The Morning Consult, 06-15-15
Broad Healthcare Networks Do Not Equal High Quality
Yevgeniy Feyman, Washington Examiner, 05-28-15
New York Innovates In Medicaid--But Ignores A Key Member Of The Team
Yevgeniy Feyman, The Health Care Blog, 05-20-15
The True Cost Of Costly Drug Development
Paul Howard, Yevgeniy Feyman, U.S. News and World Report, 05-20-15
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