Sen. Dan Coats (R-Ind.) introduced an “FDA Mission Reform Act" yesterday, aiming to clarify the mission of the federal watchdog agency and clarify the regulatory environment.
The bill would add language to the FDA’s mission statement calling for it to establish a predictable and clear regulatory environment while promoting job growth in the U.S.
"The current regulatory environment created by the FDA has forced American companies to eliminate jobs and move operations overseas," Coats said in prepared remarks. "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."
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."
Rep. Mike Rogers (R-Mich.) introduced a similar bill in the U.S. House of Representatives earlier this year.
Coats too has been vocal in his opposition to the 2.3 percent medical device tax, which is set to go into effect in 2013. He co-sponsored a bill that would repeal the legislation, which industry groups claim is a "job-killer."
The federal watchdog agency’s medical device review and approval process has been getting some flak from lawmakers recently. House Republicans introduced 10 bills aimed at the FDA’s medical device review and approval process.
The bills, sent to the Energy & Commerce Committee in October, detailed proposed measures to reform the predictability, consistency and transparency of the federal watchdog agency’s med-tech review process.