Author: Susan Peschin, MHS
Date: August 3rd, 2017
Alliance for Aging Research (Alliance) President and CEO Susan Peschin, MHS, has issued the following statement in response to the U.S. Senate’s passage of the FDA Reauthorization Act of 2017:
The Alliance for Aging Research applauds the Senate’s bipartisan, nearly unanimous passage of the FDA Reauthorization Act of 2017. We appreciate the Senate’s urgency in passing this legislation, as the current user fees agreement is set to expire on September 30. The Alliance has been a strong supporter of this legislation and has played a lead role in working with the FDA and industry on the PDUFA and MDUFA portions of the bill. In addition to helping the FDA get life-changing therapies to the American people more quickly and efficiently, these user fees fund patient-safety and patient-centered programs. The latest iteration of the bill will strengthen the FDA’s Sentinel Initiative, an electronic system proactively monitoring the safety of medical products after they are approved and marketed to the public. It also gives patients a greater voice in the development of new medicines. It funds programs such as the Patient-Focused Drug Development Initiative as well as advancements in the use of real-world evidence and patient-focused methods in regulatory decision making. This bill now goes to President Trump for his consideration, and we urge the president to take immediate action and sign the bill into law.