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Harkin, Enzi, Upton and Waxman Announce Bipartisan Agreement on Food and Drug Administration Safety and Innovation Act

WASHINGTON, DC– Senate Health, Education, Labor and Pensions Committee Chairman Tom Harkin (D-IA), Ranking Member Mike Enzi (R-WY), House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Ranking Member Henry A. Waxman (D-CA) today announced a bipartisan agreement on the Food and Drug Administration Safety and Innovation Act, S 3187, which reauthorizes Food and Drug Administration user fees to ensure the continuation of various FDA programs and the creation of new ones to facilitate the review and approval of life-saving and life-improving drugs and medical devices. As part of the agreement, the FDA will commit to implementing specific performance goals and reforms to ensure patients receive quality care and access to new therapies. Text of the legislation is available here.

“This legislation takes significant steps to ensure that Americans get better access to safe, innovative medicines and medical devices while reducing prescription drug costs and modernizing the FDA,” said Senator Tom Harkin, Chairman of the Senate Health, Education, Labor and Pensions Committee.  “I am pleased that working together, Senator Enzi, Representative Upton, Representative Waxman and I were able to reach agreement on this critically important legislation. I’ve said it before and I’ll say it again – this process should be a model for Congressional bipartisan cooperation. I hope that the House and Senate will act to approve it soon so we can send it to the president for his signature without delay.”

“Passing this important legislation will provide Americans with access to life-saving medicines and medical devices, and show that Congress can still function when it comes to critical life-and-death issues like this one,” said Senator Mike Enzi, Ranking Member of the Senate Health, Education, Labor and Pensions Committee. “I am proud that even during an election year, Congress is poised to carry out its most important function — passing bills that matter.”


“The U.S. has led the global medical device and biopharmaceutical industry for decades, and this agreement will keep and create those jobs here in America,” said Rep. Fred Upton, Chairman of the House Energy and Commerce Committee. “In addition to reauthorizing the user fees that are so important to the FDA’s review and approval efforts, the bill also includes several reforms to build certainty and transparency into the process. Many of these reforms were based on suggestions by patients and innovators who shared first hand experience of how the current system is broken. I want to thank my colleagues on both sides of the aisle for their bipartisanship throughout this process. Because of their outstanding work, we have an agreement that is a win for patients, American innovation and jobs.”

“I am pleased that we have been able to work together across the aisle on user fee legislation that will bring FDA critical dollars to expedite its review of drugs and medical devices—and, for the first time, generic drugs and biosimilars,” said Rep. Henry A. Waxman, Ranking Member of the House Energy and Commerce Committee. “As a result, patients will have access to new and innovative therapies in a timely way. This legislation contains many important provisions, including language to spur development of new antibiotics to treat serious and life-threatening bacterial infections. This bipartisan effort has resulted in important legislation that will improve the lives of American patients.”