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Paulsen, Altmire Lead Bipartisan Effort to Increase Efficiency at the FDA

Press Release

Location: Washington, DC

Representatives Erik Paulsen (MN-03), Jason Altmire (PA-04), Adam Kinzinger (IL-11), Brett Guthrie (KY-02), Brian Bilbray (CA-50), Bill Cassidy (LA-6), John Shimkus (IL-19), Cathy McMorris Rodgers (WA-5), Marsha Blackburn (TN-7), Bob Latta (OH-5), Mary Bono Mack (CA-45), John Kline (MN-2), Michele Bachmann (MN-6) and Chip Cravaack (MN-8) today introduced legislation to increase consistency and efficiency in the FDA's third party review process. The FDA currently uses third parties to review device applications and conduct inspections, however, the FDA's utilization of third parties could be improved and increased to provide greater efficiency to device companies and, ultimately, patients, all the while saving valuable resources.

H.R. 3205, The FDA Renewing Efficiency From Outside Reviewer Management (REFORM) Act, would reauthorize review and inspection for five years, decrease review time by requiring FDA to review third party submissions within 30 days of receipt, improve the quality of reviews by providing transparency around decision summaries and Total Product Life Cycle information, and ensure standards are kept by requiring third party reviewers to request reaccreditation every three years.

"By focusing on efficiency and requiring reviewers get re-accreditation every three years, this legislation speeds up patient access to life-saving medical devices while ensuring high-quality reviews focused on patient safety," said Rep. Paulsen. "This common sense legislation will save both the FDA and medical device innovators valuable resources, and ensure we keep and expand jobs here in our communities."

"The FDA has made it a habit of enforcing unclear and sporadic regulations that cause delays on the approval of medical devices that could save lives and whose development could create good-paying jobs," Rep. Altmire said. "This bill reforms the way medical devices are inspected by clarifying regulations and speeding up the review process. This industry represents a large portion of America's job suppliers, and it is important for us to remove these unneeded barriers to their growth."

"Our nation has been a world leader in medical technology for several decades, which in turn creates thousands of jobs and produces equipment that has saved or improved our quality of life," said Rep. Kinzinger. "This legislation would establish a review process for medical devices that is effective, efficient, transparent, and will eliminate the threat of sending these good paying jobs overseas."

"Improving third party review is a critical step in updating the current regulatory review process at the FDA," said Rep. Guthrie. "I am hopeful this bill will make the review process more efficient, which will help manufacturers create more jobs."

"The San Diego life science cluster is one of the largest in the world, accounting for more than 24,000 jobs in our region. These jobs and American patients are threatened by Washington bureaucracy, unnecessary regulations, and a disturbing culture within the Food and Drug Administration," said Rep. Bilbray. "H.R. 3205, will help protect San Diego jobs and improve the efficiency of the device approval process so life-saving devices can get to American patients. Congressman Paulsen continues to be a leader on these issues, and this legislation is further proof of his dedication to protect the health and livelihood of Americans."

"I am proud to support this legislation. Encouraging the FDA to use third party reviewers would ensure patients have access to life saving medical devices in a more timely fashion," said Rep. Blackburn. "The medical device industry employs nearly 10,000 people in my home state of Tennessee, and this important bill will provide them with both transparency and consistency and allow them to further invest their resources in our state."

Paulsen has been working closely with a team of Members of the House Energy and Commerce Committee, which has jurisdiction over the FDA, to craft comprehensive legislation to restore transparency, predictability, and efficiency of the agency. In addition to his own bill on third party reviews, Paulsen is the original cosponsor of nine other bills which address the least burdensome principle, conflicts of interest, Humanitarian Use Devices, the de novo process, good guidance practices, international standards, device tracking, reviewer expertise, the FDA's mission, and ensuring device safety.

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