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NEW: The Manhattan Institute Announces Its
21st Century FDA Task Force
The Manhattan Institute announces its 21st Century FDA Task Force. The FDA Task Force, with over 20 members, will devise and promote better science-based regulations at the FDA that will decrease the time and cost required for new drug development while increasing the safety and efficacy of the nation’s drug supply. The Task Force is composed of experts from academia, industry, and the policy community, and will develop and disseminate proposals to reform the FDA’s drug approval and safety monitoring procedures.
In recent years, the creation of new medicines has become increasingly difficult, costly, and time consuming. Currently, it may take up to a decade and cost over $800 million to successfully develop a single new medicine for FDA approval. At the same time, recent safety concerns over pediatric antidepressants and widely used painkillers like Vioxx have riveted the public’s attention on the FDA’s inability to identify serious side effects until years after a drug is released onto the market.
The reality is that safety and innovation are two sides of the same coin. Over the past 10 years, computer-assisted technologies have allowed us to decipher the human genome and led to a revolution in the basic sciences. Today, more than ever, is it possible to “personalize” medicine to ensure that the right patient gets the right medicine—and avoids the wrong ones—based on his or her genetic profile. However, the FDA’s regulatory framework for developing, approving, and monitoring the safe use of medicines (called the “critical path”) is essentially the same as it was 30 years ago. As a result, the full potential of personalized medicine is frustrated and the FDA is unable to reassure patients that the prescriptions they use are as safe and effective as possible. The solution proposed by our Task Force is a new, flexible, science-driven FDA critical path that will encourage the development of more effective, safer, and less expensive personalized medicines.
Robert Goldberg, PhD, Task Force chairman and director of the Manhattan Institute’s Center for Medical Progress, has created a brain trust of leading scientists and stakeholders that, as Dr. Goldberg observes, “will leverage the current crisis to transform the FDA and embrace the promise of 21st century technologies.” The Task Force also includes Nobel Prize winner Joshua Lederberg, PhD, Professor Emeritus at Rockefeller University and Frederick Goodwin, MD, Professor of Psychiatry and Director of the Center on Neuroscience, Medical Progress, and Society at the George Washington University Medical Center, and former head of the National Institute of Mental Health.
Currently the Task Force is compiling working papers from its members; holding meetings with prominent scientific experts and industry leaders; and preparing a document for release in Fall 2005 with specific recommendations for reform.
For more information on Robert Goldberg,PhD, please visit:
http://www.manhattan-institute.org/html/goldberg.htm
To read Robert Goldberg’s latest article “The Right Road to Safe Drugs,” please visit:
http://www.manhattan-institute.org/html/_nypost-the_right_road.htm
For more information on the 21st Century FDA Task Force please visit:
http://www.manhattan-institute.org/html/fda_task_force.htm
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.
www.manhattan-institute.org
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