U.S. Senator Amy Klobuchar and U.S. Representative Erik Paulsen today met with Food and Drug Administration (FDA) Commissioner Margaret Hamburg to discuss ways to improve the medical device approval process and encourage innovation. Klobuchar and Paulsen have both introduced bills that would reduce regulatory burdens that unnecessarily delay new medical devices from reaching the market. Today the FDA and medical technology companies announced an agreement as part of the reauthorization of the Medical Device User Fee Act that proposes inclusion of a provision in Klobuchar's legislation. The provision would require an independent agency to conduct a thorough review of the FDA's management and regulatory processes, including the impact on medical device innovation. Paulsen's advocacy led to recognition of the need for greater accountability on the part of FDA; the agreement would significantly improve review times and hold FDA responsible for total review time goals.
"In order to maintain America's competitiveness in the medical device industry, we need to ensure that red tape isn't preventing companies in Minnesota and across the country from delivering life-saving products to the patients who need them," Klobuchar said. "Today's announcement is a positive step forward for my legislation, and I will continue to work with Commissioner Hamburg, Congressman Paulsen, and other stakeholders to improve our processes and promote safe, pioneering technologies that save lives and create good jobs in Minnesota."
"Minnesota medical device innovators are a true American success story -- employing more than 35,000 of our neighbors, friends, and family members," said Rep. Paulsen. "I am encouraged by the FDA's commitment to reduce unpredictable regulatory hurdles and improve review times. I look forward to continuing my conversation with Commissioner Hamburg, Senator Klobuchar, and my colleagues in the House, to ensure the agency lives up to the commitments it has made."
Over the past few years the FDA's regulation has become increasingly longer and more difficult, 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.
Klobuchar's legislation, the Medical Device Regulatory Improvement Act, would help streamline the FDA's regulation of medical devices by clarifying FDA's current least burdensome requirements. These provisions will 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 would also require the FDA to be subject to the same conflicts of interest requirements as the rest of the federal government. Finally, the legislation would direct the FDA to contract with an outside entity to conduct a thorough review of the management and regulatory processes at the FDA's Center for Devices and Radiological Health, including the impact on medical device innovation.
As Co-Chair of the House Medical Technology Caucus, Paulsen has been a champion of medical technology innovation. He is the author of the FDA Renewing Efficiency From Outside Reviewer Management (REFORM) Act, which would reduce FDA workload by streamline the third party review and inspection programs. Paulsen is the original cosponsor of nine other bills that would reform the device review process through provisions to reaffirm least burdensome provisions, change conflict of interest rules, streamline the de novo process, and increase FDA accountability. Paulsen is also the author of the Protect Medical Innovation Act, which would repeal the $20 billion tax on medical devices, which will go into effect in 2013.
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.