Senator Coats Calls for FDA Mission Reform

Posted 09 December 2011 | By

Sen. Dan Coats (R-Ind.) introduced an "FDA Mission Reform Act" last week, aiming to clarify the mission of the federal watchdog agency and clarify the regulatory environment. The bill would add language to the US Food and Drug Administration's (FDA) mission statement calling for it to establish a predictable and clear regulatory environment while promoting job growth in the US. The federal watchdog agency's new mission would require it to establish a regulatory system that: "Advances medical innovation by incorporating modern scientific tools, standards, and approaches to ensure the predictable, consistent and efficient review, clearance, approval and licensing of innovative products (including drugs, devices and biological products); protects the public health and enables patients to access novel products while promoting economic growth, innovation, competitiveness and job creation among the industries regulated by the FDA; identifies and uses the most innovative and least burdensome tools for achieving regulatory ends; and "Incorporates a patient-focused benefit-risk framework that accounts for varying degrees of risk tolerance." (Mass Device)


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