Spurring Medical Innovation, Help FDA Meet 21st Century Challenges And Advance Patient Access To Safer And More Effective Drugs And Medical Devices

Main Category: Medical Devices / Diagnostics
Also Included In: Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals
Article Date: 01 Oct 2008 - 9:00 PDT

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Today, October 1, 2008, the Manhattan Institute's Center for Medical Progress announces the launch of Project FDA. Project FDA is an initiative designed to help the Food and Drug Administration develop the 21st Century technologies and regulations that can accelerate medical innovation, and get safer and more effective treatments to patients faster, cheaper, and smarter than is currently possible.

Today, it may take more than a decade and hundreds of millions of dollars to bring a single new medical product innovation to the public from initial conception to FDA approval. During this time, potentially life-saving drugs and devices are kept out of the hands of those who need them the most. The Project FDA committee, chaired by Tomas Philipson, PhD, is composed of ten practicing physician-scientists, economists, medical ethicists and policy experts who will critically examine the existing regulatory environment affecting medical innovation and suggest ways that regulators, policymakers, and companies can improve it.

http://www.manhattan-institute.org/projectfda

Some issues Project FDA will address:

How do we balance drug safety and rapid patient access to new medicines?

Solution:

-- Improve the ability of the FDA to collaborate with outside organizations to validate new scientific discoveries that have the potential to speed patient access to new therapies

-- Promote cost-benefit analysis of existing FDA regulations and procedures as they affect the "speed v. safety" tradeoff in the development and regulatory review of new medicines to ensure that they promote overall social welfare

-- Increase FDA funding for Critical Path Initiative and related activities, which have the potential to revolutionize drug development and drug safety

Pharmaceutical litigation drives up drug prices and reduces innovation without a corresponding increase in drug safety. What can we do to ensure that compensation reaches truly injured patients without deterring medical innovation?

Solution:

-- Implement regulatory preemption for FDA approved labeling from state "failure to warn lawsuits" so that the FDA can make a national judgment about appropriate drug labeling and drug warnings

-- Create a science-based administrative compensation program for drugs similar to the one currently used for vaccine related injuries so that patients who are injured by serious but unforeseen side effects receive appropriate and timely compensation

Some critics have argued that profit-driven companies corrupt medical science and drive up health care costs, without a corresponding benefit to patients. Can profit seeking behavior be reconciled with a commitment to the highest scientific standards and improving patient wellbeing?

Solution:

-- The U.S. leads the world in biomedical innovation because we have a robust partnership between the public and private sectors. Tremendous gains in the treatment of heart disease, cancer, and AIDS would not have been possible without that collaboration. We will educate the public and policymakers on the value of innovation and the need for close working relationships between academic medical centers, industry, and regulators in the quest to translate basic science discoveries into new cures. We will explain why conflict-of-interest regulations can sometimes do more harm than good, and are based on an incorrect understanding of medical professionalism.

"The FDA is probably the most scientifically educated regulatory agency in government. But there are powerful incentives for it to overemphasize safety at the expense of faster patient access to new therapies. By giving regulators the right incentives and funding to develop new scientific tools, like biomarkers, the FDA can accelerate medical innovation without compromising public health." - Tomas Philipson, Chairman, Project FDA

"Certain aspects of the culture at the FDA work against our country's need to maintain its worldwide competitiveness in biomedical research and development. Project FDA will help to identify specific aspects of FDA regulations and oversight that could be modified to best serve the healthcare community." - Paul Offit, MD

Committee Members:

Dennis A. Ausiello, MD, Harvard Medical School, Chief of Medicine, Massachusetts General Hospital; Director of Pfizer, Inc

Arthur Daemmrich, PhD, assistant professor, Harvard Business School; member of the Harvard Business School Healthcare Initiative

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

Paul Howard, PhD, senior fellow and director, Center for Medical Progress, Manhattan Institute; managing editor, MedicalProgressToday.com

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 A. Offit, MD, Chief of the Division of Infectious Diseases and Director of the Vaccine Education Center, Children's Hospital of Philadelphia; Professor of Vaccinology and Professor of Pediatrics, University of Pennsylvania School of Medicine

Daniel P. Petrylak, MD, Associate Professor of Medicine and Program Director, Genitourinary Oncology Section, Division of Hematology/Oncology, Columbia University Medical Center

Tomas J. Philipson, PhD, chairman of Project FDA; professor, Harris School for Public Policy, University of Chicago; former Bush Administration Senior Economic Advisor to the head of the Food and Drug Administration (FDA) during 2003-04, and Senior Economic Advisor to the head of the Centers for Medicare and Medicaid Services (CMS) in 2004-05

Lance K. Stell, Ph.D., FACFE, John and Mary West Thatcher Professor of Philosophy, Davidson College; Clinical Professor, Department of Internal Medicine, Carolinas Medical Center; Full Professor (Adjunct), Translational Science Institute, Wake Forest University School of Medicine

Thomas P. Stossel, MD, senior fellow, Center for Medical Progress, Manhattan Institute; Director, Division of Translational Medicine, Brigham & Women's Hospital; American Cancer Society Professor of Medicine, Harvard Medical School

The Manhattan Institute, a 501(c)(3), is a think tank whose mission is to develop and disseminate new ideas that foster greater economic choice and individual responsibility.

http://www.manhattan-institute.org