Senator Dan Coats (R-Ind.) has introduced legislation to clarify and reform the mission of FDA in order to promote job creation. The FDA Mission Reform Act (S. 1972) would require 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,” says 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 FDA.

• Identifies and uses the most innovative and least burdensome tools for achieving regulatory ends.

• Incorporates a patient-focused benefit-risk framework that accounts for varying degrees of risk tolerance.

“We believe these goals will help reinforce the agency’s commitment to improving the efficiency and predictability of its device review process and to working with industry to ensure American patients have timely access to safe and effective medical innovations,” says Stephen J. Ubl, president and CEO of AdvaMed.

Ubl says AdvaMed applauds the introduction of the legislation, noting that it will facilitate innovation and apply a risk-benefit framework that takes patients into account are key parts of FDA’s mission.
Rep. Mike Rogers (R-Mich.) introduced similar legislation earlier this year in the House of Representatives. Senator Kelly Ayotte (R-NH) is an original cosponsor of the Senate bill.