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Utilizing 21st century technologies to help develop better FDA regulations and
a faster and safer drug and medical device pipeline

       
  Andrew C. von Eschenbach, MD
 


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

   
  Arthur Daemmrich, PhD
 

Assistant professor, Harvard Business School

   
  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

   
  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

   
   
 
 

The Digital Future of Molecular Medicine: Rethinking FDA Regulation
The Digital Future of Molecular Medicine: Rethinking FDA Regulation
By Peter Huber
May 2013

Project FDA reports archive >>

 

FDA Reform Can Lift U.S. Economy,
By Andrew von Eschenbach,
Bloomberg, 02-28-13

FDA Approvals Are a Matter of Life and Death,
By Andrew von Eschenbach,
Wall Street Journal, 06-17-12

Toward a 21st-Century FDA,
By Andrew von Eschenbach,
Wall Street Journal, 04-15-12

Medical Innovation: How the U.S. Can Retain Its Lead
By Andrew von Eschenbach,
Wall Street Journal, 02-14-12

Former FDA Commissioner Andrew von Eschenbach To Head Manhattan Institute's Project FDA Initiative

 
Project FDA director, Andrew von Eschenbach, and University of Chicago professor, Tomas J. Philipson, explain why lowering unnecessary barriers facing innovative US companies, particularly in the biopharmaceutical sector, will help grow the US Economy.

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.

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 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.

As part of our mission to advance public dialogue and debate about the importance of supporting medical innovation and personalized medicine, the Center for Medical Progress also hosts Medical Progress Today, a blog that provides a forum for economists, scientists, and policy experts to explore the scientific, regulatory, and market frameworks that will best support 21st century medical innovation.


Get FDA Off the Slow Track
By Paul Howard, Washington Examiner, 05-17-13

An Unhealthy Advantage For Generic Medicines
By Paul Howard, Washington Times, 04-09-13

FDA Reform Can Lift U.S. Economy
By Dr. Andrew von Eschenbach, Tomas J. Philipson, Bloomberg, 02-28-13

Why Does FDA Keep Drugmakers From Informing Doctors?
By James R. Copland, Paul Howard, Investor's Business Daily, 01-09-13

FDA Approvals Are a Matter of Life and Death
By Dr. Andrew von Eschenbach, Wall Street Journal, 06-17-12

More on this topic >>

 

 

       

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