ARTICLES/OP-EDS:

'Caution Syndrome' Infects The FDA David Gratzer, Forbes.com, 05-22-09 How To Maintain FDA Standards Thomas Stossel and Bruce Gingles, Forbes.com, April 29, 2009 "GPS" for Health Care Paul Howard and Gualberto Ruano, City Journal Online, 4-15-09 It's Time to Fight the 'PharmaScolds' Thomas Stossel and David Shaywitz, Wall Street Journal, 04-08-09 Borrow From The HIV Battle Plan To Help Win War Against Cancer Investor's Business Daily, Tomas Philipson, 03-14-09 Don't surrender innovation in the name of health care reform Washington Examiner, Tomas Philipson, 03-11-09 Who Pays for a Cancer Drug?, Peter W. Huber, Forbes, 01-06-09 Curing Diversity , Peter W. Huber, City Journal, Autumn 2008 The FDA and drug pre-emption, Tomas Philipson, Chairman, Project FDA, Washington Times, 10-20-08 Don't handcuff scientists, Thomas Stossel, Committee Member, Project FDA, Boston Globe, 10-20-08

NEW REPORT In the Wake of Wyeth v. Levine: Making the Case for FDA Preemption and Administrative Compensation By James R. Copland and Paul Howard March 2009 OP-ED: A 'cure' worse than gangrene, Washington Times, Paul Howard and Jim Copland, 3-8-09 Medical Progress Bulletin From the Broad Brush to the Fine Point: How to Enable Personalized Medicine December 2008 Experts Discuss Priorities for the New FDA Commissioner in our "Second Opinion" Expert Forum! Expert Panel:   • Henry I. Miller   • Paul H. Rubin   • Alex Tabarrok   • Mary Woolley Click here to read their second opinions.

The time and costs required to bring new medical products to market is growing ever larger. 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. The slow pace and high cost of development contributes to the cost of health care and delays patient access to potentially lifesaving innovations.

At the same time, the FDA is facing a crisis in confidence among consumers, media and policymakers, with some critics declaring the agency “broken”—unable to ensure that medical products offered for sale in the U.S. are reasonably safe and effective. Doctors and academic medical centers, too, face growing concerns about allegedly harmful interactions with industry during the development and marketing of medical products. The result is a growing call for sweeping new regulation of the industry at both the state and federal levels.

Advances in the molecular and genetic understanding of disease have the potential to make health care more predictive and preventive rather than empirical and reactive—thus improving patient outcomes and reducing health care costs. Unfortunately, in our zeal to reduce risks, regulate potential conflicts, and mandate transparency, we may reduce incentives for companies to develop and market improved products due to increased tort litigation; inhibit doctors from collaborating with companies in designing safer and more effective products; and slow the FDA’s efforts to bring its oversight activities into conformity with the latest scientific and technical advances.

The membership of Project FDA includes practicing physician–scientists, economists, medical ethicists and policy experts. Committee members will examine the current framework and direction of federal and state regulation to ensure that the medical innovation pipeline remains robust and that all stakeholders—including industry, academic medical centers, and regulators—are taking advantage of appropriate opportunities to bring safer and more effective products to market utilizing 21st Century technologies.

Issues that Project FDA will address include:

• Improve the ability of the FDA to collaborate with outside organizations to develop regulatory standards that are adapted to the latest scientific findings on clinical trial design, biomarkers, diagnostics and disease modeling that have the potential to speed patient access to groundbreaking new therapies
• 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
• Promote cost-benefit analysis of existing FDA regulations 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
• 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; this also includes examining the impact of conflict-of-interest regulations on FDA Advisory Committees as well as on the ability of academic researchers to partner with industry to develop new therapies
• Increase FDA funding for Critical Path Initiative and related activities, which have the potential to revolutionize drug development and drug safety