MINNEAPOLIS, MN – U.S. Senators Amy Klobuchar and Al Franken today held a meeting with Food and Drug Administration (FDA) Commissioner Margaret Hamburg and Minnesota medical device businesses to discuss efforts to expand access to lifesaving devices. Minnesota is a leader in innovation and production of lifesaving medical devices, with the industry creating tens of thousands of jobs across the state. Klobuchar and Franken have been leaders in the effort to reduce regulatory burdens that unnecessarily delay new medical devices from reaching the market.
“Today’s meeting highlighted the importance of ensuring 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.”
"Minnesota’s innovative medical device industry not only creates tens of thousands of well paying jobs in our state, but also produces internationally respected life-saving devices," said Sen. Franken. "Today's meeting was a great opportunity for the FDA to get a better understanding of the hurdles our companies often face when trying to bring their life-saving products to market in the quickest, safest way possible. It was a very constructive meeting that will pay dividends in the future."
The Food and Drug Administration Safety and Innovation Act, signed into law last month, included key provisions from Klobuchar’s bipartisan legislation, the Medical Device Regulatory Improvement Act, that will help streamline the FDA’s regulation of medical devices by strengthening FDA’s current least burdensome requirements. This 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 also included Klobuchar’s provisions to address FDA’s overly restrictive conflicts of interest requirements and requires an independent review of the FDA’s Center on Device and Radiological Health.
Sen. Franken was a key member of a bipartisan group of Senate Health Committee members that authored the bill. Additionally, he championed three significant provisions that were included in the legislation passed by the Senate. The first was a provision that would allow the FDA to tap a deeper well of expertise from the medical device industry during the approval process, allowing devices to get to market more quickly. The second would encourage medical device makers to develop treatments for rare diseases, making it easier for patients with those diseases to get treatment. Sen. Franken's third provision would require that the FDA withdraw guidance released by the FDA that could have created new and burdensome requirements for companies making changes to their approved devices, which would cause even more delays.
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