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Coats Introduces Bill to Reform FDA Mission, Encourage Job Creation

December 9, 2011

12/1211 Senator Dan Coats (R-Ind.) Thursday introduced legislation to clarify and reform the mission of the Food and Drug Administration (FDA) in order to promote job creation. The FDA Mission Reform Act would require the FDA to establish a predictable, consistent and transparent regulatory environment.
“The current regulatory environment created by the FDA has forced American companies to eliminate jobs and move operations overseas,” said Coats. “Unpredictable and burdensome regulations from this agency have severely impacted medical device manufacturing, an important industry in Indiana’s economy. These are tough economic times, and we need to support, not punish, our job creators so they can innovate and expand. This legislation will encourage the development of innovative products and protect American jobs.”

Coats’ legislation would add language to the FDA mission statement calling for the agency 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.

Rep. Mike Rogers (R-Mich.) introduced similar legislation earlier this year in the House of Representatives. Senator Kelly Ayotte (R-N.H.) is an original co-sponsor of the Senate bill.