WASHINGTON, D.C. – U.S. Senator Amy Klobuchar announced that her bipartisan provisions to boost medical device innovation will be included in upcoming legislation being considered by the Senate Health, Education, Labor and Pensions (HELP) Committee. The provisions would reduce regulatory burdens that unnecessarily delay new, life-saving medical devices from reaching the market without compromising consumer safety.
“This legislation is a positive step forward for these critical provisions that will help ensure regulatory red tape isn’t preventing companies in Minnesota and across the country from delivering life-saving products to the patients that need them,” Klobuchar said.“I will continue to push for common-sense reforms that encourage innovation and promote safe, pioneering technologies that save lives and create good jobs in Minnesota.”
Over the past few years the FDA’s regulation has become increasingly burdensome and less transparent, delaying, and in some cases preventing, new and innovative devices from reaching the market. Recent studies showed that the average time to approve a 510(k) application has increased 43% from the 2003-2007 period to 2010, and the average time to approve a premarket approval (PMA) application has increased 75%. A recent survey of venture capitalist life sciences investors showed that almost 40% of investors are more likely to shift their operations and investments overseas because of FDA’s regulatory challenges.
The Senate HELP Committee legislation includes key provisions from Klobuchar’s bipartisan legislation, the Medical Device Regulatory Improvement Act, that would help streamline the FDA’s regulation of medical devices by strengthening FDA’s current least burdensome requirements. This would ensure that when making regulatory decisions on medical devices, FDA focuses only on the relevant information during the decision-making process, considers appropriate alternatives to reduce the time, effort, and cost of reaching regulatory decisions, and uses all reasonable mechanisms to reduce review times when making these decisions. The bill also includes Klobuchar’s provision to streamline FDA’s overly restrictive conflicts of interest requirements.
Klobuchar is the chair of the Senate Commerce Subcommittee on Competitiveness, Innovation, and Export Promotion, and has been a leader in the effort to cut red tape that threatens innovation in the medical device industry. After a December 2010 report surveyed over 200 medical technology companies and found that confusing and contradictory regulations are stifling innovation, Klobuchar pushed the Food and Drug Administration (FDA) to reform its slow and inconsistent 510(k) approval process for medical devices to maintain safety, protect patients, and encourage innovation. Klobuchar also founded the bipartisan Senate Medical Technology Caucus to increase awareness about issues facing the industry.