Budget Provision Klobuchar, Franken, Paulsen Fought For Will Help Improve Safety and Efficiency for Medical Device Approval Process

Press Release

U.S. Senators Amy Klobuchar and Al Franken and Representative Erik Paulsen today announced that a provision in the budget that they fought for to improve the safety and efficiency of the medical device approval process was included in the final version of the omnibus spending bill. Under sequestration, users fees - funds collected from medical device companies intended to support the FDA and its approval process for new devices - were frozen. The provision included in the bill will help unfreeze the funds collected from the user fee and ensure that they are used for their intended purpose, reducing the burden on both medical manufacturers and the FDA.

"Businesses like Medtronic are producing the world's highest quality medical products and having a huge impact on countless patients' lives," Klobuchar said. "The fact that this money businesses were giving the FDA was frozen during the sequester made no sense, and that's why I fought for this provision to allow this money to finally be used for its intended purposes - to give the FDA the resources it needs to review products in a timely manner and get them to patients."

"Many Minnesotans depend on medical devices to keep them alive and depend on this important industry to support their families," Franken said. "Unfortunately, the sequester took an unfair toll on medical device companies and slowed down the approval process for life-saving devices. I was proud to help lead the bipartisan effort to fix this problem and make sure these products can come to market in a timely fashion, and I'm pleased we were able to come together and get it done."

"Minnesota is home to hundreds of medical device companies, large and small, that have paid user fees to help the FDA review life-improving, life-saving devices," Paulsen said. "Unfortunately, sequestration made it impossible for the FDA to use these funds, which is why I co-authored legislation to make these user fees exempt. I am pleased that Congress could come together on a bipartisan funding bill that makes these voluntary, private industry dollars accessible so they may be used to improve patient safety."

"Resolving the frozen User Fees in the Omnibus spending bill is a tremendous accomplishment for Minnesota's medical technology community," said Dale Wahlstrom, CEO of LifeScience Alley. "Having made a significant commitment to a stronger partnership with the FDA, we are excited to be able to see these resources utilized to bring life-saving therapies to the patients who desperately need them. We are particularly proud of the leadership of the Minnesota Congressional delegation on this issue and applaud their commitment to bipartisan solutions that are good for the economy and the patients we serve."

As a co-chair of the bipartisan Medical Technology Caucus, Senator Klobuchar has consistently fought for Minnesota medical device companies. In addition to introducing legislation with Senator Orrin Hatch (R-UT) to repeal the medical device tax, Klobuchar also led the effort to delay the implementation of the device tax, and successfully secured 17 other Democratic Senators to join her in a letter to Senate Majority Leader Reid urging delay. In addition, The Food and Drug Administration Safety and Innovation Act, signed into law in 2012, 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.

Senator Franken is a strong supporter of Minnesota's medical device industry. Last year he was a leading cosponsor of the bipartisan FDA User Fee Protection Act that would give the FDA full access to user fees paid by medical device and diagnostics companies, the very issue resolved in the budget agreement. In addition, as a member of the Senate Health Committee, Senator Franken played a critical role in enacting into law the Food and Drug Administration Safety and Innovation Act, which reauthorized the user fee agreements between the medical technology industries and the FDA. Senator Franken has also consistently opposed the medical device tax and, after successfully working to cut it in half, is continuing to work toward a bipartisan solution that will repeal the tax entirely.

Paulsen, a champion of small business and advocate of free enterprise, entrepreneurship, and innovation, serves on the House Ways and Means Committee, the bicameral Joint Economic Committee, and is co-chair of the Congressional Medical Technology Caucus. He is the author of a bill to repeal the medical device tax, worked on numerous provision included in the Food and Drug Administration Safety and Innovation Act, and has been a leader in advocating for regulatory harmonization in free trade agreements to streamline approval for life-saving devices across the globe.

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