Sen. Dan Coats (R-IN) has introduced a bill to clarify and reform FDA’s mission in order to keep jobs from going overseas.
“The FDA Mission Reform Act would require the FDA to establish a predictable, consistent and transparent regulatory environment,” Coats said in a news release.
The measure’s language calls for a regulatory system that:
• Advances medical innovation by incorporating modern tools, standards, and approaches to ensure the predictable and efficient review, clearance, approval and licensing of 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.
From the February 01, 2012 Issue of MM+M - Medical Marketing and Media
