Senate intros new version of FDA reform bill

Sens. Dan Coats and Kelly Ayotte, Republicans of Indiana and New Hampshire, respectively, have introduced a Senate version of the FDA Mission Reform Act, which was submitted to the House in October by Michigan Republican Mike Rogers.

The new legislation would require the FDA to establish a predictable, consistent and transparent regulatory environment, according to a statement from Coats’ office. Its backers’ intent is to clarify and reform the mission of the agency as a way to create jobs.

Coats and Ayotte are calling for the agency to amend its mission statement 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;
• Protects the public health and enables patients to access novel products while promoting economic growth, innovation, competitiveness and job creation;
• 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.

“The current regulatory environment created by the FDA has forced American companies to eliminate jobs and move operations overseas,” said Coats. “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.”