“We Need to Improve FDA Regulations to
Approve Life-Saving Treatments & Create Jobs”

 

Washington, DC – Rep. Cathy McMorris Rodgers (R-WA), Rep. Leonard Lance (R-NJ), and six other members of the House Energy and Commerce Committee introduced the Keeping America Competitive through Harmonization Act today.  This bill would streamline and improve the regulatory process for medical devices, spur innovation in a high-tech, high-paying field, bolster America’s competitiveness, and create much-needed jobs.   

“While America has led the medical device industry for decades, our leadership is being threatened by the FDA’s unpredictable, inconsistent and inefficient regulation of medical devices,” said Rep. McMorris Rodgers.  “According to job creators I’ve met, harmonizing FDA requirements with those of foreign regulators would help improve FDA regulation, expedite approval of life-saving and life-improving treatments, and improve the environment for job creation.  Our bill will charge the FDA with undertaking the common-sense reforms that are needed to keep America the world capital of medical innovation.” 

On Sep. 20, 2011, Rep. McMorris Rodgers hosted the first “Jobs and Innovation Forum” on Capitol Hill with a special focus on medical device innovators, how the regulatory process impedes them, and how to improve that process.  The next day, The Hill published her op-ed, The Medical Device Industry and Jobs.  To read it, click here.

The Keeping America Competitive through Harmonization Act would require FDA, to the maximum extent feasible, to enter into agreements with Tier One countries, like Australia, Canada, Israel and those of the European Union, on methods and approaches to harmonizing regulatory requirements for premarket review, inspections and common international labels.

In the United States, medical technology is directly responsible for employing more than 400,000 people, paying employees more than $24 billion, and transporting more than $135 billion in products around the world.  In Washington State alone, more than 8,700 jobs have been created by the medical innovation industry with a payroll of $526 million and more than $2 billion in sales.