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“Madden’s market-based solution appeals to economists like me who are keenly aware of the critical importance of institutional design for a system to promote decentralized responses close to the local knowledge that is available to physicians and their patients, but not to the FDA. This book is fundamentally bipartisan and should be read in that spirit.”
Vernon L. Smith
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The purpose of the drugs-to-patients system should be to deliver better drugs, sooner, at lower cost, not to chase after the impossible goal of zero risk.
The Buy cialis brand pills canada. No Prescription Generics Online. Freetochoosemedicine plan does not eliminate the role of the FDA in the drug approval process. A drug company can opt to remain within the current approval process for any of its drugs. FTCM sets up a competing system that would allow manufacturers to market new drugs after completion of the FDA’s Phase I testing and at least one round of Phase II testing, contingent upon certification of a FTCM Committee that the drug successfully completed that testing. The drug could then be made available to patients and, based on the real-world, observational data collected from patient usage, the company could seek Observational Approval from the FDA to market the drug to the general public. The FTCM system of patients use, usage monitoring and reporting and FDA observational approval, would bring drugs to market faster, at reduced prices and encourage expansion of companies seeking to develop, test and market new drugs.
The U.S. drugs-to-patients system fails to achieve its overall system goal of better drugs, sooner, at lower cost.
The key constraint that impedes achieving this goal is the FDA’s enormously expensive and time consuming clinical testing process.
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